As an IT manager in the pharmaceutical industry, it is crucial to select an Electronic Laboratory Notebook (ELN) solution that meets the specific needs of your laboratory while also adhering to regulatory requirements set by the Food and Drug Administration (FDA). The process of selecting an ELN solution can be complex and time-consuming, but by following a few key steps, IT managers can ensure that they choose the right solution for their laboratory.
The first step in selecting an ELN solution is to identify the specific needs of your laboratory. This includes determining the type of data that will be stored in the ELN, the number of users who will be accessing the system, and any specific compliance requirements that must be met. By identifying these needs, IT managers can narrow down the list of potential solutions and focus on those that are best suited for their laboratory.
Once the specific needs of the laboratory have been identified, IT managers should thoroughly research the different ELN solutions that are available. This includes reading product literature, attending webinars or product demonstrations, and speaking with vendors or other IT managers who have experience with the solutions. By researching the different solutions, IT managers can get a better understanding of the features and capabilities of each system and how they align with the needs of their laboratory.
Another important step in selecting an ELN solution is to evaluate the vendor’s compliance and regulatory experience. The ELN solution should be able to meet regulatory requirements set by the FDA and should have a proven track record of compliance in the pharmaceutical industry. IT managers should also look for vendors who have experience working with regulatory bodies such as the FDA and can provide guidance on compliance-related issues.
Additionally, IT managers should also consider the vendor’s support and maintenance services. The ELN solution should be easy to use and should have a user-friendly interface. Additionally, the vendor should provide comprehensive training and support services to help IT managers and laboratory staff quickly become proficient with the system. The vendor should also have a reliable maintenance and upgrade plan.
Security is another important consideration when selecting an ELN solution. The system should have robust security features that prevent unauthorized access and tampering of data. This includes encryption of data and user authentication to ensure that only authorized personnel can access the system. Additionally, the ELN solution should have an audit trail feature to record all data changes and activities.
Scalability is another key consideration when selecting an ELN solution. As the laboratory’s needs change over time, the ELN solution should be able to adapt and grow with the laboratory. The solution should have the ability to handle large amounts of data and should be able to accommodate an increasing number of users.
Finally, IT managers should also consider the cost of the ELN solution. This includes not only the initial cost of the system but also the ongoing costs of maintenance, support, and upgrades. IT managers should also consider the potential return on investment (ROI) of the ELN solution and how it will benefit the laboratory in the long term.
In conclusion, selecting an ELN solution for a pharmaceutical laboratory can be a complex and time-consuming process. However, by following a few key steps, IT managers can ensure that they choose the right solution for their laboratory. This includes identifying the specific needs of the laboratory, researching different solutions, evaluating the vendor’s compliance and regulatory experience, considering the vendor’s support and maintenance services, security, scalability, and cost. With the right ELN solution in place, IT managers can improve efficiency, compliance and data management in their laboratory.
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Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.
Josh Guyer,
Senior Pharmaceutical Scientist
Has your team considered utilizing an ELN or LIMS, or Batch Record or Stability solution in the laboratory, but didn’t know how or where to start? End-user requirements for any informatics solution or platform are an important part and a good place to begin your journey towards a paperless lab.
SciCord has put together an example of what end-user requirements may look like for a laboratory:
To define end-user requirements to support R&D, Quality Control, and Manufacture as implemented at Organization.
Implement a commercial off the shelf (COTS) application capable of supporting R&D, Quality Control, and Manufacture business organizations.
ELN | Electronic Laboratory Notebook |
LIMS | Laboratory Information Management System |
COTS | Commercial off-the-shelf software |
URL | “Uniform Resource Locator” – protocol for specifying addresses on the Internet. |
21CFR Part 11 | Code of US Federal Regulations dealing with electronic records and signatures. |
Closed System | Software environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. |
Plug and Play | Term defining a process that allows functionality to be integrated into an existing application and which will work perfectly when first used or connected, without reconfiguration or adjustment by the user. |
Configuration | Specific settings which define how the system operates, including roles and permissions. |
End-user requirements are designed to define the procedures and practices critical to support laboratory and production operations and associated documentation. Each end-user requirement is assigned unique requirement numbers to support traceability to test scripts.
UR-Qual-01 | The system manages user roles for at minimum Administrator, Scientist, Data Reviewer, Sample Manager, Customer, and Quality Assurance. |
UR-Qual-02 | The system supports granular permissions for system functionality. |
UR-Qual-03 | The system manages a matrix of roles versus permissions. |
UR-Qual-04 | The system manages User definition – creation, activation, updates, deactivation, and role assignment. |
UR-Qual-05 | Grouping mechanism, such as the “site”, which governs the default scope of information displayed to a user. Site scope may be overridden to display a wider range of information. |
UR-Qual-06 | A mechanism must be available to expose specific information or documentation to internal or external customers |
UR-Qual-07 | Granular access to specific system information can be managed (Claims). This requirement adds an additional layer of control to permissions. Example: Use of an instrument is restricted to users completing a specific training exercise. |
UR-Qual-08 | The system enforces password strength and expiration in accordance with organizational requirements OR implements the organization’s LDAP system for single sign-on. |
UR-Qual-09 | The system provides archival of documentation and samples in long-term readable format. |
UR-Qual-10 | The system supports messaging both internal to the solution or via email. Messages are automatically generated based on user-defined events. |
UR-DocLife-01 | The system supports a controlled document lifecycle including document status for: creation, in progress, optional review, optional approval, and complete. |
UR-DocLife-02 | The system supports rework, where reviewed or complete documents are returned to an editable state. |
UR-DocLife-03 | Documents may be canceled but may not be deleted. |
UR-DocLife-04 | Document content may be viewed in a read-only mode |
UR-DocEdit-01 | Document edit supports recording and formatting scientific information. |
UR-DocEdit-02 | Calculations are supported with Excel compatible formula functionality. |
UR-DocEdit-03 | Document edit supports cell content types: text, dates, numbers, and calculated formulas. |
UR-DocEdit-04 | Document Editor supports Copy & Paste operations. |
UR-DocEdit-05 | Document Editor supports URLs, Pictures, & Lines. |
UR-DocEdit-06 | Support in context Signatures within document content. |
UR-DocEdit-07 | Support temporary work on a document by a different user to record information. |
UR-DocEdit-08 | Support file attachment within document content. |
UR-DocEdit-09 | Support linkage between resource definition and resource usage. |
UR-DocEdit-10 | Support extraction of structured data |
UR-DocEdit-11 | Support data entry in standard spreadsheet and rich text formats. |
UR-DocRev-01 | Support addition and management of review notes on a document. Notes must be removed when document is completed. |
UR-DocRev-02 | Support review alerts for visualization of situations requiring reviewer attention. |
UR-DocRev-03 | Highlight/mark all entries related to audited records under Review |
UR-DocRev-04 | Support partial reviews and multiple reviewers |
UR-Spl-01 | The system supports a controlled sample lifecycle including sample status for: creation, in progress, available, optional review, and optional complete. |
UR-Spl-02 | Support configurable sample types and configurable sample attributes. |
UR-Spl-03 | Support linkage between samples and documents. |
UR-Spl-04 | Support label printing for Samples. Include barcodes on the label. |
UR-Spl-05 | Support sample inventory. |
UR-Spl-06 | System supports management of hierarchical sample locations |
UR-Spl-07 | Sample task management is supported. Tasks should include at minimum:
1) what needs to be done, 2) who is responsible (individual or group), 3) start date and completion date |
UR-Sup-01 | The preferred solution requires minimal overhead by the organization and is provided as SaaS (Software as a Service). The solution is provisioned, maintained, and fully supported by the vendor. |
UR-Sup-02 | The preferred solution is provided as a Closed System to be more easily validated and managed. |
UR-Sup-03 | The preferred solution provides an industry-standard data migration path such as XML to support transfer of organization data to another solution if circumstances require. |
UR-Sup-04 | The preferred solution features a modular architecture that can be easily enhanced and extended by adding plug and play modules & components. |
UR-Sup-05 | Scheduling of updates and releases are managed by the organization – not the vendor. |
UR-Sup-06 | Vendor validation package (Solution Requirements, Functional Specification, Design Specification, Test Plans, Test Executions, Matrix, Summary Report) |
UR-Sup-07 | Documented Backup and Recovery procedure. |
UR-Sup-08 | Documented Service Level Agreement (SLA) defining:
· Service Availability · Support Coverage · Support Guidelines |
UR-Sup-09 | Issue Management |
UR-Comp-01 | The solution supports flexible life cycles for documents, specifications, and samples. At minimum, life cycles must include author(s), reviewer(s), and approver. |
UR-Comp-02 | Screen locking can be implemented on organization defined “unused” time interval. |
UR-Comp-03 | A comprehensive audit trail is implemented. The audit trail should be easily displayed and understood by reviewers and auditors. Audit reasons can be required for change events. |
UR-Comp-04 | The solution generates a comprehensive “readable” archive bundle for long-term data storage. The archive bundles should be available for storage inside the organization’s network. |
UR-Data-01 | The solution supports definition of structured data in the format Test-Measurement. |
UR-Data-02 | Structured data is associated with samples or documents. |
UR-Data-03 | Structured data includes definition of analyst, date, units, replicate number, method, and method version. |
UR-Data-04 | The definition of structured data may be extended through a set of flexible qualifiers. |
UR-Data-05 | Structured data is displayed for a specific sample or for a filtered group of samples. |
UR-Data-06 | Structured data may be queried from a DataMart. The DataMart tables should be in stacked or in wide form tables to support queries from third party visualization tools such as JMP, PowerBI, Spotfire, Excel, or Visio. |
UR-Data-07 | Specifications can be applied against structured data. Specification should at minimum support warning and error limits for text or numeric data. The results associated with a specification are displayed with outcomes. |
UR-Rep-01 | Reports can be generated for structured data in either pdf or spreadsheet format. |
UR-Rep-02 | Basic reports can be defined using a set of filters available in the user interface. |
UR-Rep-03 | Advanced reports can be defined by the organization by users with a knowledge of spreadsheet applications. |
UR-Rep-04 | Reports can be scheduled and delivered either via email or to a defined folder within the system. |
UR-Inter-01 | Solution supports real-time connections with instruments such as balances and pH meters. |
UR-Inter-02 | Instrument files can be attached to documentation. |
UR-Inter-03 | Attached instrument files can be “parsed” to extract specific information for additional processing or reporting. |
UR-Inter-04 | Instruments can “print” directly to the solution using a printer driver. |
UR-Inter-05 | Custom interfaces are provided for specific instrument applications |
UR-Inter-06 | Chromatography interface is provided for industry standard vendors (Waters, Agilent) |
UR-Res-01 | The solution manages resources such Standards, Solutions, Supplies, Chemicals, Protocols, and Methods |
UR-Res-02 | Resource usage can be identified – instances where a resource was used within a specified date range. |
UR-Res-03 | Manage Resource Expiration dates and availability |
UR-Res-04 | Manage Resource location |
UR-Res-05 | Manage Resource inventory |
UR-Res-06 | Manage Instrument logbooks including metrology (calibration due dates, in/out of service, scheduling, and recording preventative maintenance). |
UR-Ext-01 | The system provides Analytical Documentation modules. |
UR-Ext-02 | The system provides Manufacture Batch Records. |
UR-Ext-03 | The system provides a Training module. |
UR-Ext-04 | The system provides a Document Management module. |
UR-Ext-05 | The system provides a Stability module. |
UR-CFRRec-01 | Limited and authorized system access. [11.10(a)] |
UR-CFRRec-02 | Limited access to selected tasks and permissions. [11.10(a)] |
UR-CFRRec-03 | Computer generated audit trail. [11.10(a)] |
UR-CFRRec-04 | Accurate and complete copies. [11.10(a)] |
UR-CFRRec-05 | Binding signatures with records. [11.10(a)] |
UR-CFRRec-06 | Procedures should be in place to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection. [11.10(b)] |
UR-CFRRec-07 | Records must be protected to enable their accurate and ready retrieval throughout the records retention period. [11.10(c)] |
UR-CFRRec-08 | Procedures should be in place to limit system access to authorized users [11.10(d)] |
UR-CFRRec-09 | Procedures should be available to use secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. [11.10(e)] |
UR-CFRRec-10 | Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as required for the subject electronic records and shall be available for agency review and copying. [11.10(e)] |
UR-CFRRec-11 | Procedures should be available to use operational system checks to enforce permitted sequencing of steps and events, as appropriate [11.10(f)] |
UR-CFRRec-12 | Procedures should be available to use authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. [11.10(g)] |
UR-CFRRec-13 | Procedures should be available to use device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. [11.10(h)] |
UR-CFRRec-14 | Procedures should be available to determine that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks”. People qualification is a GxP requirement and not specific to Part 11. [11.10(i)] |
UR-CFRRec-15 | Procedures should be available to establish, and adhere to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification. [11.10(j)] |
UR-CFRRec-16 | Procedures should be in place for appropriate controls over systems documentation including: (1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. (2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation. [11.10(k)] |
UR-CFRSig-01 | Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. (4) The items identified in this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout). |
UR-CFRSig-02 | Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means |
UR-CFRSig-03 | Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. Before an organization establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. |
UR-CFRSig-04 | Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.
(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. |
UR-CFRSig-05 | Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such as an identification code and password. |
UR-CFRSig-06 | Persons who use electronic signatures based upon the use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password. (b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). (c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls. (d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management. (e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner. |
Looking for other resources, press releases, articles, or documentation?
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.
Josh Guyer,
Senior Pharmaceutical Scientist
Quality control (QC) labs play a crucial role in the pharmaceutical industry by ensuring the safety and efficacy of drug products. These labs are responsible for conducting a wide range of tests, including raw material testing, in-process testing, stability testing, and finished product testing, among others. With the increasing complexity of drug development and the need to comply with regulatory requirements, quality control labs face numerous challenges in managing and organizing their data.
To overcome these challenges, many quality control labs are now turning to Lab Informatics Platforms. The SciCord Informatics Platform is a computer-based systems that provide a centralized platform for managing and storing laboratory data. These solutions offer numerous benefits for quality control labs, including improved data management, enhanced data accessibility, streamlined workflows, and regulatory compliance.
One of the primary benefits of an informatics solution is improved data management. These solutions provide a centralized platform for storing and managing laboratory data, reducing the risk of data loss or errors associated with manual data entry. These tools also provide a secure platform for storing sensitive information, such as test results, ensuring that the data is protected against unauthorized access.
In addition, Informatics Platforms provide a user-friendly interface for capturing and organizing laboratory data, making it easier for quality control labs to manage their information. With SciCord Informatics Platform, laboratory data can be easily searched, retrieved, and analyzed, improving decision-making and reducing the time and effort required to manage data.
Another benefit of these tools is enhanced data accessibility. These solutions provide easy access to laboratory data for stakeholders such as QA/QC, R&D, and regulatory authorities. With SciCord Informatics Platform, quality control labs can share their data with stakeholders in real-time, improving communication and reducing miscommunication.
Lab Informatics solutions provide a platform for collaboration among cross-functional teams involved in laboratory testing, making it easier for teams to work together and share information. With these tools, stakeholders can access laboratory data from anywhere, at any time, using a computer, improving efficiency and reducing the need for manual data entry.
Another benefit of Informatics Platforms is streamlined workflow. These solutions can automate and streamline laboratory workflows, reducing manual efforts and errors. For example, these tools can be used to automate the creation of test protocols, reducing the time and effort required to complete these tasks.
The SciCord Informatics Platform can track laboratory work, making it easier for quality control labs to monitor progress and ensure that work is completed on time. Work requests within our tool notify scientists when certain tests need to be executed against specified samples. A calendar view allows managers to see the day’s and upcoming weeks work and plan accordingly.
Finally, Informatics Platform solutions are compliant with regulatory requirements for data integrity and security, reducing the risk of regulatory penalties or fines. For example, the SciCord Informatics Platform can be used to comply with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) requirements, ensuring that laboratory data is accurate, complete, and secure. These tools help manage and track change control, making it easier for quality control labs to ensure that changes to laboratory data are properly documented and approved. Quality control labs can ensure that their data is in compliance with regulatory requirements, reducing the risk of regulatory penalties or fines.
If you are looking for a solution to improve data management and regulatory compliance in your quality control lab, consider the SciCord Informatics Platform. With the right solution, you can improve efficiency, reduce errors, and ensure that your data is secure and accessible. Digital lab solutions are a valuable investment for quality control labs in the pharmaceutical industry and can help you stay ahead of the curve in the ever-evolving pharmaceutical industry.
Looking for other resources, press releases, articles, or documentation?
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.
Josh Guyer,
Senior Pharmaceutical Scientist
Our platform is strategically built upon the robust Microsoft Azure Cloud infrastructure, recognized globally for its state-of-the-art data security features, comprehensive compliance capabilities, and unmatched scalability. By harnessing Azure’s advanced security controls, robust encryption mechanisms, and continuous monitoring protocols, SciCord guarantees the utmost integrity and confidentiality of your sensitive data, effectively shielding against diverse cyber threats and vulnerabilities.
In addition to leveraging Azure’s built-in security capabilities, SciCord maintains rigorous Standard Operating Procedures (SOPs) meticulously crafted to establish a structured framework for implementing and enforcing stringent security measures. These SOPs, accessible to all our clients, encompass critical aspects such as Access Control, Privileged Access Management, Incident Response Planning, Backup and Recovery Procedures, and Change Management Protocols.
Privileged Access Management: We implement strict protocols for managing privileged accounts and administrative access, including regular review and rotation of credentials, multi-factor authentication (MFA), and least privilege principles to minimize the risk of insider threats and unauthorized system alterations.
Incident Response Planning: SciCord maintains a comprehensive incident response plan (IRP) designed to swiftly and effectively mitigate security incidents. This proactive approach includes predefined escalation procedures, incident categorization, containment strategies, forensic analysis capabilities, and communication protocols to minimize disruption and ensure prompt resolution.
Backup and Recovery Procedures: To safeguard against data loss and ensure business continuity, SciCord implements robust backup and recovery strategies. Regularly scheduled backups are conducted with strict adherence to industry best practices, ensuring data integrity and availability in the event of hardware failures, natural disasters, or malicious attacks.
Change Management Protocols: We adhere to stringent change management practices to carefully orchestrate and document changes to our systems, applications, and infrastructure. Each change undergoes thorough assessment, testing, approval, and implementation procedures to mitigate risks and maintain system stability and security.
SOC 2 (Service Organization Control 2) stands as a preeminent auditing standard developed by the American Institute of CPAs (AICPA). It focuses on five critical trust service criteria: security, availability, processing integrity, confidentiality, and privacy of customer data. Achieving SOC 2 compliance underscores our dedication to maintaining a secure environment for your valuable information.
Implementing SOC 2 involves:
ISO 27001 serves as a globally recognized information security management standard, providing a systematic approach to safeguarding sensitive data’s confidentiality, integrity, and availability.
Our implementation of ISO 27001 includes:
For a comprehensive list of our compliance offerings via Azure, please refer to the Azure compliance documentation. Additionally, we make our internal SOPs and guidelines available upon request.
Use our SciCord Informatics Platform with confidence, assured that industry-leading security practices protect your data. For inquiries about our security protocols, compliance benchmarks, or data management procedures, please contact us. Your peace of mind is paramount, and we are committed to ensuring your experience with us is secure, smooth, and successful.
Looking for other resources, press releases, articles, or documentation?
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.
Josh Guyer,
Senior Pharmaceutical Scientist
Electronic Laboratory Notebooks (ELNs) and Laboratory Information Management Systems (LIMS) are essential tools in modern FDA pharmaceutical labs. These systems streamline data management, enhance efficiency, and ensure compliance with stringent regulatory standards set by the Food and Drug Administration (FDA). This article delves into the key aspects of FDA compliance for ELNs and LIMS, emphasizing the importance of maintaining auditable trails, robust security, accurate reporting, and system validation.
SciCord ELN: Ensuring Compliance
SciCord ELN is designed to help pharmaceutical labs maintain FDA 21 CFR Part 11 compliance. Key features of SciCord ELN include:
Conclusion
Complying with FDA regulations is crucial for the pharmaceutical industry. ELNs and LIMS, like SciCord ELN, provide the tools necessary to meet these requirements. By ensuring auditable trails, advanced security, accurate reporting, and regular validation, pharmaceutical labs can maintain compliance and ensure the safety and efficacy of their products.
Looking for other resources, press releases, articles, or documentation?
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.
Josh Guyer,
Senior Pharmaceutical Scientist
In today’s fast-paced scientific landscape, laboratories face mounting pressures to streamline operations and boost efficiency, especially in large research institutions managing numerous concurrent projects with limited resources. These requirements necessitate the adoption of advanced Informatics Platforms like SciCord to effectively address these challenges.
By providing a secure and intuitive platform, SciCord facilitates the seamless transition from traditional paper-based methods to digital data management, enhancing operational agility without disrupting ongoing projects. This transformation not only minimizes the administrative burden associated with manual record-keeping but also ensures data accuracy and accessibility across diverse research endeavors.
SciCord’s Informatics Platform stands out as a versatile solution designed to enhance laboratory efficiency and data management. Its secure and intuitive interface modernize laboratory workflows, enabling researchers to manage and analyze data effectively.
One of the platform’s hallmark features is its capability to automate repetitive tasks effectively. Researchers can create customizable templates for digital notebooks, ensuring consistent data capture in standardized formats. This automation not only saves time but also minimizes errors that often accompany manual data entry. Moreover, SciCord supports data exportation in various formats, facilitating integration with other software tools and analytical platforms, thus enhancing the versatility of data utilization.
Another advantage of SciCord’s platform is its system for data organization and accessibility. Unlike conventional paper-based systems prone to inefficiencies in data retrieval and analysis, SciCord enables researchers to easily search and retrieve data using keywords and parameters. This capability not only boosts productivity but also promotes real-time collaboration among team members, enabling consistent project coordination and data analysis.
In terms of data security and regulatory compliance, SciCord provides a secure cloud-based storage solution. This protects data against risks such as loss, theft, or physical damage inherent in traditional paper records. Furthermore, the platform adheres to stringent regulatory standards like FDA 21 CFR Part 11 and GxP protocols, ensuring its suitability for deployment in highly regulated industries such as pharmaceuticals.
SciCord’s Informatics Platform empowers laboratories to optimize operations through streamlined workflows, enhanced data management capabilities, and robust security measures. By leveraging these advanced functionalities, researchers can focus more on scientific endeavors while confidently managing and utilizing their research data efficiently.
The platform’s automation features are particularly beneficial – by automating routine tasks such as data entry and report generation, SciCord significantly reduces the time and effort researchers spend on administrative duties. This not only improves overall efficiency but also allows scientists to allocate more time to core research activities, accelerating the pace of scientific discovery.
SciCord enhances collaboration within research teams and across institutions. Its intuitive user interface and cloud-based accessibility enable researchers to share data seamlessly, collaborate on projects in real-time, and facilitate interdisciplinary research efforts. This collaborative environment not only enhances communication but also fosters innovation by leveraging diverse expertise and perspectives.
Central to SciCord’s effectiveness is its resilient data management capabilities. Unlike traditional paper-based methods that often result in fragmented data storage and limited accessibility, SciCord ensures centralized data storage and easy retrieval. Researchers can organize and categorize data using customizable tags and keywords, making it effortless to locate specific information needed for analysis or compliance purposes.
SciCord supports data integration with a wide range of laboratory instruments and analytical tools. This integration allows researchers to capture data directly from instruments, ensuring accuracy and reliability in data acquisition. The platform’s compatibility with various file formats and APIs further enhances its utility, enabling researchers to leverage existing software tools and easily integrate SciCord into their workflow ecosystems.
In regulated industries such as pharmaceuticals, data security and compliance are paramount concerns. SciCord addresses these challenges by providing a secure cloud-based environment that adheres to industry regulations and standards. All data stored in SciCord is encrypted and backed up regularly, ensuring data integrity and continuity even in the event of unforeseen disruptions.
In conclusion, SciCord’s Informatics Platform emerges as a crucial asset for laboratories aiming to optimize workflows and enhance efficiency. By automating repetitive tasks and offering intuitive data capture tools, SciCord simplifies the transition from traditional to digital record-keeping, thereby saving valuable time and minimizing errors. The platform’s sturdy capabilities extend to improving data organization and accessibility, empowering researchers to swiftly retrieve and analyze information critical to their projects.
SciCord prioritizes data security with its secure cloud-based storage solutions, ensuring compliance with stringent regulatory standards such as FDA 21 CFR Part 11 and GxP protocols. This feature not only safeguards valuable research data but also mitigates risks associated with physical record-keeping methods.
Looking for other resources, press releases, articles, or documentation?
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.
Josh Guyer,
Senior Pharmaceutical Scientist
For centuries paper notebooks have been integral tools for scientists who laboriously and carefully recorded specific details of their research and experiments.
That picture began to change in the 1990s with the development of the ELN (electronic lab notebook.) An ELN is a digital version of the traditional lab notebook. Like a paper notebook, it documents the who, what, when, where, how, and why of daily activities in the lab.
This article explains the benefits of a paperless lab, identifies the hurdles researchers face in implementing an ELN, and addresses the keys to a successful transition from paper notebooks to an ELN.
Two essentials of scientific discovery are 1) reliable data in a format that’s accessible and easy-to-use and 2) time efficiencies that help researchers get critical products to market in a timely fashion. An ELN surpasses paper notebooks in the ability to provide both of these critical elements.
An ELN’s collection, retrieval, and analysis features help scientists generate data that is:
Legible
In a perfect world, lab notes would always be written neatly. They’d never have anything spilled on them. They would be stored securely, protected from moisture, aging, and disasters like fires and floods.
Unfortunately, even the most meticulous laboratory environment isn’t perfect. Some notes are legible only to the scientist who wrote them. Accidents happen. Occasionally, disaster strikes.
The result is that a percentage of notes are unusable. Scientists may disagree over how widespread the problem is, but they concur that not all hand-written lab notes are legible.
Accurate
Extremely precise formulas can be solved instantly, accurately, and repeatedly, regardless of the researcher who performs the calculations. The system incorporates date and time stamps as well as user identification to verify who did what.
A growing number of ELNs–including the hybrid SciCord ELN/LIMS–also utilize a spreadsheet format. With a spreadsheet, researchers can enter one–or hundreds–of formulas that automatically calculate data entered into the cell. This feature reduces entry errors and saves time for scientists and reviewers.
Accessible and Retrievable
Accessing and retrieving information stored in paper notebooks can be a nightmare, especially if the data is stored off-site. Rifling through dozens–or hundreds–of notebooks takes time, even if items are stored carefully and consistently. Locating the exact page with the specific details requires more time. The process can be tedious and time-consuming, even when all team members follow protocols precisely.
Using a search function, an ELN allows you to quickly access mountains of data and retrieve the precise information needed.
– Jana Erjavec, Ph.D., on SciCord ELN/LIMS
In addition to standard search functionality of sample and document descriptions, some ELNs (including SciCord ELN/LIMS) support definition of data attributes and incorporate filtering on a much more granular level.
Shareable
Scientists working on projects that utilize the same data can share their insights and results with others without sacrificing control or having their data compromised. ELN security protocols limit access to the data and restrict–or deny– data manipulation.
The shareable feature also mitigates difficulties that arise when a researcher gets sick, takes a vacation, retires, or leaves the lab to work elsewhere. Work that relies upon that person’s data isn’t delayed or halted altogether.
Secure
While no ELN can guarantee 100% security, electronic notebook systems provide superior data protection compared to paper notebooks. Unlike paper notebooks, an ELN offers safety measures that include layered passwords, encryption, replication, regular data backup, and–often–multiple storage locations.
Time efficiencies
The adage– “Time is Money” –is true, particularly in the pharmaceutical industry where, according to a study completed in 2020, “the median cost of getting a new drug into the market was $985 million, and the average cost was $1.3 billion.”
Those statistics make a strong case for transitioning to an ELN. A survey by SciNote asserts that, “On average, researchers save 9 hours per week by using an ELN, while doing the same amount of work!” Thus, with a 40-hour work week and a 50-week work year, researchers would finish the year’s planned activities halfway through week 39.
Time savings accrue in virtually every part of the lab–data entry, search, and retrieval; calculations and statistics; inventory control and labeling; and documentation and reports. These efficiencies allow researchers to accomplish more with an ELN than they could without one.
An ELN provides solutions for some of the most pressing issues facing labs today. However, utilization remains low.
– Dr. Simon Bungers
From LabFolder
Why is that? Here are the difficulties scientists frequently mention:
No pressing need to change
Many labs don’t see the need to change, even though they know that technology has affected virtually every other aspect of scientific discovery. It’s not just that paper notebooks have been the status quo for centuries. Some scientists suspect that ELN systems may cause bigger problems than they solve.
Worries about decreased control and security
When ELNs first hit the market, researchers in virtually every field questioned the wisdom of releasing control of their data. They knew the shortcomings posed by paper notebooks but still felt that their data was safer when they controlled where it went and who accessed it.
That feeling has shifted a bit, but some scientists–especially those who meticulously follow data safety protocols and adhere to GLP (Good Laboratory Practices)–are still reluctant to trust an ELN.
Complexity of learning and using an ELN
Since laboratory science is a complex world of testing and discovery, it demands attention to detail and intense focus. Some scientists worry that an ELN will add an unnecessary level of complexity that will muddle or derail their professional focus and lead to costly errors.
Cost
Each ELN is tailored to the lab that uses it. Therefore, there’s no accurate estimate of the cost to implement an “average” ELN for an “average” lab. The cost varies based upon the number of users, the scale of the lab’s required services, and whether the ELN is hosted or located on-premise.
The initial cash outlay to install and coordinate the hardware and software needs of an ELN deters some labs from making the switch. Decision-makers also need to account for the subscription cost of a hosted ELN or the required hardware upgrades for an ELN that’s located on the premises.
Key person(s) to facilitate the process
Successful transitioning from paper notebooks won’t happen without one or more people from your lab who facilitate the process by:
A mindset that accepts the change as a transition, not a fixed-point change
Implementing any systemic change takes time. Virtually everyone in the lab will have to transition both mentally and physically.
A transition team composed of personnel from the lab and the ELN will be integral to the process of tactfully and skillfully guiding researchers as they learn the nuances of the software and how to adhere to GLP while using it.
Appropriate timing
In a busy lab, there will never be a perfect moment to switch from paper notebooks to an ELN. Research and experiments that are already in progress will be disrupted. Everyone’s productivity will dip briefly while he or she acclimates to the ELN.
However, given the financial benefits of implementing an ELN, waiting for the perfect moment could be very costly, both in terms of the rate of getting drugs on the market and in the additional ROI the lab could generate with an efficient ELN. Unless the lab is facing a crisis, the best time to transition to an ELN is now.
An excellent ELN provider
An excellent ELN provider for your lab is the one that meets your needs and supports you during and after the transition. As you choose a provider, ask these questions:
SciCord is a hybrid ELN/LIMS, featuring a spreadsheet paradigm, that combines the compliance and structured aspects of a Laboratory Information Management System (LIMS) with the flexibility of an Electronic Laboratory Notebook (ELN). The ELN and LIMS functions integrate seamlessly and enable your company to quickly reap the benefits of enhanced data and time efficiencies as you continue to meet compliance standards and follow GLP.
Looking for other resources, press releases, articles, or documentation?
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.
Josh Guyer,
Senior Pharmaceutical Scientist
The pharmaceutical industry has historically identified ‘the best” ELN vendor and then force-fit that solution across all organization functions. There were practical reasons for this practice:
However, organizations have also discovered that there are significant costs with the one size fits all approach:
Although Electronic Laboratory Notebooks (ELNs) are considered general-purpose tools, each has its own strengths and weaknesses. The scientific community is incredibly diverse, encompassing a wide range of disciplines such as Biology, Small Molecule Chemistry, Inhaled Pharmaceuticals, and Dermal applications. Each of these areas has unique requirements and workflows, and what works well for one might be entirely unsuitable for another.
Moreover, the different phases of scientific work—research, development, and manufacturing—each have distinct needs. Research activities are typically more exploratory and flexible, requiring ELNs that support a high degree of customization and novel data types. Development activities, on the other hand, demand more structured and rigorous documentation to comply with regulatory standards and to ensure reproducibility. Manufacturing phases prioritize efficiency, scalability, and integration with other enterprise systems. ELN designers cannot possibly be experts in all these diverse fields and phases, so they tend to focus their designs on specific communities to better meet their specialized needs.
For example, a research-oriented ELN might offer advanced data analysis tools and flexible entry formats to accommodate the unpredictable nature of early-stage experiments. However, this same flexibility can become a liability in a development setting, where standardized processes and stringent documentation are critical. Forcing such a research-oriented application into a development organization can lead to significant issues: workflows might become cumbersome, compliance risks could increase, and scientists may experience frustration due to the system not aligning with their precise needs. This misalignment not only hampers productivity but can also lead to costly errors and inefficiencies.
The Plug and Play nature of SaaS ELN solutions can be liberating! Organizations are now free to consider the benefits to be derived from implementing the best solution for a functional group.
While ELNs are versatile tools, their effectiveness is maximized when they are tailored to the specific demands of the scientific discipline and phase they are intended to support. A one-size-fits-all approach often fails to deliver the nuanced functionality required across different scientific domains and stages of work, leading to suboptimal outcomes and user dissatisfaction. Therefore, it is crucial for organizations to select ELNs that are purpose-built for their specific needs, ensuring that each function within the organization can operate at its highest potential.
Looking for other resources, press releases, articles, or documentation?
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.
Josh Guyer,
Senior Pharmaceutical Scientist
SciCord will develop robust and reliable software templates that not only meet our customers’ current requirements but also adapt to future needs and challenges effectively. Regular evaluation and improvement based on testing outcomes and user feedback are key to maintaining high standards of quality and usability. Transitioning software compliantly involves several key steps to ensure a smooth and effective process:
When it comes to pharmaceutical computer software assurance, the FDA (U.S. Food and Drug Administration) focuses on ensuring that software used in pharmaceutical manufacturing, testing, and distribution meets certain standards of quality, reliability, and regulatory compliance. Here are some key aspects of FDA pharmaceutical computer software assurance:
Overall, FDA pharmaceutical computer software assurance aims to ensure the reliability, security, and regulatory compliance of software systems used in pharmaceutical manufacturing, testing, distribution, and other related activities. Pharmaceutical companies must implement and maintain effective software assurance practices to ensure product quality and patient safety. This is where the SciCord Platform team can help ease your transition to a validated environment.
Use cases help determine the specific scenarios and involves understanding the target audience and their requirements.
Our team works together with you, our customer, in defining the functionalities, features, and components that the template will include. This helps in setting clear boundaries for what the template will deliver. Here are key aspects to consider:
By thoroughly defining use cases and scoping the template’s functionalities, SciCord can ensure that the template meets the specific needs of its intended users effectively and efficiently. This approach also helps in managing expectations and providing clarity during the development and deployment phases.
This involves working closely with the customer and designing templates that effectively perform the duties that are set by the user requirements. This requires customer feedback to ensure that the template/s aesthetic and functionality match the customer requirements.
By following a structured approach to testing, including thorough validation, risk assessment, and adherence to requirements, SciCord can ensure that the software template is robust, dependable, and meets the needs of its intended users effectively. Regular updates and maintenance based on feedback and new requirements will further enhance its usability and reliability over time.
The SciCord team is well versed in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), which are validation protocols used in various industries, especially pharmaceuticals, biotechnology, and medical devices. Here is a brief overview of each:
These protocols are crucial for ensuring that equipment, systems, and processes meet quality standards and regulatory requirements before they are used in production or other critical applications. Constant communication with all stakeholders involved is crucial to successful implementation.
Creating documentation for a validated software environment is crucial to ensure compliance with regulatory requirements and to maintain the integrity of the validated state. SciCord can create thorough documentation for a validated software environment that meets regulatory standards and supports ongoing compliance efforts.
By following these steps and practices, SciCord will develop effective software templates that save time, promote consistency, and improve the overall quality of software development within your organization or community.
Implementing software templates involves developing the actual content of the template itself and providing comprehensive documentation to guide users on its usage and customization. SciCord will be able to handle all your needs for all required documents as well as training your team.
Looking for other resources, press releases, articles, or documentation?
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.
Josh Guyer,
Senior Pharmaceutical Scientist
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