Choosing an ELN solution is Complex

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.

Criteria for selecting an ELN

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.

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.

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.

Conclusion

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.

Starting with the Basics: End-User Requirements in Lab Informatics

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:

1 Purpose

To define end-user requirements to support R&D, Quality Control, and Manufacture as implemented at Organization.

2 Scope

Implement a commercial off the shelf (COTS) application capable of supporting R&D, Quality Control, and Manufacture business organizations.

3 Abbreviations and Definitions

3.1 Abbreviations

3.2 Definitions

4 Requirements

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.

4.1 Quality

4.2 Document Lifecycle

4.3 Document Edit

4.4 Document Review

4.5 Sample Management

4.6 Support

4.7 Compliance

4.8 Data

4.9 Reports

4.10 Interface

4.11 Resources

4.12 Extensions

4.13 21CFR Part 11 Records

4.14 21CFR Part 11 Electronic Signatures

Informatics Platform for Quality Control (QC) Labs

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.

Improved Data Management

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.

Enhanced Data Accessibility

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.

Streamlined Workflow

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.

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.

Securing Your Data with SOC 2 and ISO 27001: Ensuring Trust in Our Informatics Platform

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.

Access Control: SciCord employs granular access controls to ensure that only authorized personnel have appropriate access to sensitive data and system functionalities. Role-based access mechanisms are meticulously configured and continuously monitored to prevent unauthorized entry or data breaches.

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.

What is SOC 2?

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:

1. Security: Our systems and infrastructure incorporate multiple layers of security controls to thwart unauthorized access and mitigate cyber threats effectively.
2. Availability: The SciCord platform ensures high availability, minimizing downtime and disruptions to your operations.
3. Processing Integrity: We maintain data accuracy and completeness through stringent controls over processing activities and data manipulation.
4. Confidentiality: Your data remains confidential through robust access controls, encryption measures, and policies that prevent unauthorized disclosure.
5. Privacy: Personal and sensitive information is shielded from unauthorized handling or exposure.

ISO 27001: Elevating Our Security Practices

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:

1. Risk Assessment: Thorough risk assessments identify potential security threats and vulnerabilities, enabling us to implement effective risk mitigation strategies.
2. Information Security Policies: Our SOPs guide team members in securely handling data, fostering a culture of heightened security awareness.
3. Access Control: We enforce stringent access controls to ensure only authorized personnel access sensitive data, minimizing the risk of data breaches.
4. Regular Auditing and Monitoring: Continuous monitoring and audits of security controls identify and address potential system weaknesses proactively.
5. Incident Response: A well-defined incident response plan enables us to swiftly minimize the impact of any security incidents and facilitate quick recovery.

Your Trust is Our Priority

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.

Introduction

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.

21 CRF Part 11 Compliance Requirements

1. Auditable Trails and Security
   One of the foundational requirements for FDA compliance is the ability to maintain a comprehensive auditable trail. ELNs and LIMS must record all data changes, including who made the changes and when. Resilient security features are crucial to prevent unauthorized access and ensure data integrity. Advanced encryption and user authentication protocols are necessary to safeguard sensitive information.
2. Accurate Reporting
   ELNs and LIMS must generate reports that meet FDA’s strict reporting standards, such as 21 CFR Part 11 and electronic records/electronic signatures (ERES). These reports should be accurate, reliable, and in the required formats to ensure regulatory compliance.
3. System Validation
   Regular validation of ELNs and LIMS is essential to confirm that the systems operate correctly. This includes ongoing testing and maintenance to promptly identify and resolve any issues. Validation ensures that the systems consistently produce reliable and accurate data, a critical aspect of FDA compliance.

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:

• Secure and Auditable Records: Advanced encryption and security protocols protect data, while the platform tracks and records all user actions.
• Electronic Signatures and Approvals: Digital signatures and an easy review and approval process ensure data integrity.
• User-Friendly Interface: Powerful search and filter tools, customizable workspaces, and detailed documentation support compliance and enhance the user experience.

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.

Streamlining Laboratory workflows

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.

How SciCord’s Informatics Platform Can Improve Lab Efficiency

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.

Optimizing Laboratory Operations

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.

Enhanced Data Management and Accessibility

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.

Data Security and Compliance

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.

Streamline your Lab’s Work Processes

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.

Transitioning Your Lab from Paper Notebooks to an ELN

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.

Why should your lab 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.

Enhanced data quality

An ELN’s collection, retrieval, and analysis features help scientists generate data that is:

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.

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.

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.

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.

What are the keys to successfully transitioning from paper notebooks to an ELN?

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:

1. Determining and communicating the benefits of transitioning. What specific problem areas will the ELN address? How will this help everyone in the lab?
2. Setting the timeframe of the transition. What schedule will be optimal? How long will the process–realistically–take? When will the ELN feel like a valuable asset rather than a liability?
3. Interfacing with the provider. The facilitator must be able to field questions from the researchers and provide answers promptly.

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:

1. Is their ELN easy to integrate and use?
2. Does this provider have feedback from satisfied customers who appreciate their software–and their service?
3. Do they offer a demo to help you get a true feel for their software?
4. What type of hosting do they provide?
5. How do they help a customer safely and quickly transition from paper notebooks to an ELN?

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.

Tailoring ELN Solutions to Diverse Scientific Needs

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.

SaaS has changed the ELN paradigm

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.

• The ELN can “speak” the language of the specific community group with targeted structure, calculations, and reports.
• Requires minimal configuration or customization. Scientists are not well known for defining “good” requirements.  Just skip this source of implementation failure.
• Instrument interface can often be provided out of the box.
• The vendor is more likely to extend the product to support the specific community.
• Individual functional groups can have more “control”, implementing and operating at their own pace.

Summary

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.

Introduction

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:

• Data Migration and Management
• Testing and Validation
• Training and Documentation
• Compliance Audits and Reviews

What it means to be FDA Compliant:

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:

1. Current Good Manufacturing Practices (cGMP): Pharmaceutical manufacturers must adhere to cGMP regulations, which include requirements for the control and documentation of software used in manufacturing processes. This ensures that software-related activities, such as batch records, electronic signatures, and process controls, meet regulatory standards.
2. Data Integrity: The FDA emphasizes the importance of data integrity in pharmaceutical software systems. This includes ensuring that data generated, processed, and stored by software systems are accurate, dependable, and attributable throughout their lifecycle.
3. Validation: Pharmaceutical companies are required to validate computer software used in GMP activities to demonstrate that it performs as intended, meets user requirements, and complies with regulatory requirements. This validation process typically includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
4. Electronic Records and Signatures: Software systems that handle electronic records and electronic signatures (ERES) must comply with FDA regulations outlined in 21 CFR Part 11. This includes requirements for system validation, audit trails, data security, and controls to prevent unauthorized access or modifications.
5. Risk Management: Like medical devices, pharmaceutical software systems must undergo risk management processes to identify and mitigate potential risks associated with software failures, data integrity issues, and regulatory non-compliance.

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.

The SciCord Platform Path to Compliance

Define the Purpose and Scope

Identify Use Cases

Use cases help determine the specific scenarios and involves understanding the target audience and their requirements.

Scope

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:

• Core Functionalities: Identify the essential features that the template must provide for the customers’ needs.

• Optional Features: Determine additional functionalities that can be optionally included or configured based on specific project needs. Examples include email notifications, file uploads, role-based access control, etc.
• Documentation: Plan for comprehensive documentation that explains how to use the template, configure it, and extend its functionalities.

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.

Template Content Development

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.

Testing and Validation

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:

1. Installation Qualification (IQ):
   • IQ ensures that equipment or systems are installed correctly and according to their specifications.
   • It verifies that all components are delivered as designed and specified, and that they are installed in the intended environment.

2. Operational Qualification (OQ):
   • OQ verifies that the equipment or system operates as intended throughout all anticipated operating ranges.
   • It ensures that the equipment functions correctly when subjected to specified operating conditions, such as upper and lower limits of operational parameters.

3. Performance Qualification (PQ):
   • PQ demonstrates that the equipment or system consistently performs according to predefined criteria over an extended period, typically using actual product or process materials.
   • It verifies that the equipment, when used in routine production or operation, produces consistent results within specified limits.

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.

Documentation Included for a Validated Environment

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.

TIP/TIR

• Technical Installation Plan: Document the installation

• Technical Installation  Report: Record any issues encountered during installation, including their impact, steps to reproduce, and resolutions.

Risk Assessment

• Identify Risks: Evaluate potential risks associated with using the template and apply risk level assessment.
• Mitigation: Develop strategies to mitigate identified risks, conducting thorough testing, or providing clear documentation.

Requirements

• Functional Requirements: Ensure the template meets all specified functional requirements.

Summary Report

• Testing Results: Summarize the outcomes of testing, including any incidents  found, their severity, and their resolutions. This will also include Template History, Documentation List, Contents of the template index, Requirement Test Matrix, and Installation Requirements.
• Compliance: Ensure the template complies with relevant standards, guidelines, or regulations applicable to its use case.

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.

Implementation and Training

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.