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:

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

• 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:

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.

White-Glove Customer Service: The SciCord Commitment

In the bustling world of laboratory information management, where precision and reliability are paramount, SciCord stands out not just for its cutting-edge solutions but for its unwavering dedication to exceptional customer service. As a small company with approximately 20 employees, we pride ourselves on offering what we like to call ‘white-glove’ customer service. This personalized, meticulous approach to customer care is one of the cornerstone reasons why potential customers should choose SciCord for their laboratory management needs.

The Essence of White-Glove Service

White-glove service is a term that evokes images of careful, detailed, and above-and-beyond service. At SciCord, this means more than just addressing issues as they arise; it involves anticipating customer needs, offering tailored solutions, and providing continuous support throughout our partnership. Our customers are not just numbers or accounts; they are partners in innovation, and their success is our mission.

Personalized Onboarding Experience

From the moment a customer decides to implement SciCord’s solutions, they are met with a highly personalized onboarding process. Unlike larger corporations that might offer a one-size-fits-all approach, SciCord dedicates time to understand each client’s unique needs and workflows. Our expert team works closely with your laboratory staff to ensure a seamless transition, minimizing downtime and maximizing efficiency.

Ongoing Support and Training

Our commitment to customer service doesn’t end once the system is up and running. SciCord offers continuous support to ensure our customers can leverage the full potential of our solutions. Whether it’s troubleshooting a technical issue, optimizing workflows, or updating the system with the latest features, our team is always available to assist.

We understand that the scientific landscape is ever-evolving, and so are the needs of our customers. Therefore, we provide ongoing training and updates to keep your team informed and your systems running at peak performance. Our proactive approach means that we often identify and address potential issues before they become problems, ensuring that your lab operations remain smooth and efficient.

Dedicated Account Management

At SciCord, every customer is assigned a dedicated account manager. This individual acts as a single point of contact, fully familiar with your laboratory’s specific requirements and challenges. Your account manager is not just a liaison; they are an advocate within SciCord, ensuring that your feedback is heard and that your needs are met promptly.

This dedicated approach allows us to build long-lasting relationships with our customers. We believe in fostering trust and understanding, which is why our account managers are always just a phone call or email away. They regularly check in to ensure everything is running smoothly and to discuss any new needs or improvements that could benefit your operations.

Customized Solutions and Flexibility

One of the hallmarks of SciCord’s white-glove service is our ability to provide customized solutions. We recognize that no two laboratories are the same, and we take pride in offering software that can be tailored to fit the specific requirements of your lab. This flexibility ensures that you are not forced into a rigid framework but instead have a solution that works seamlessly with your existing processes.

Our team collaborates closely with your staff to understand the intricacies of your workflows and suggests modifications or enhancements that can lead to greater efficiency and accuracy. This level of customization is rare in the industry and is a testament to our commitment to providing solutions that truly add value to your operations.

Conclusion

In the competitive field of laboratory information management, SciCord’s dedication to white-glove customer service sets us apart. Our personalized approach, from the initial onboarding to ongoing support and customized solutions, ensures that our customers receive the highest level of care and attention. We view our customers as partners and are committed to their success, making SciCord not just a service provider, but a trusted ally in achieving your laboratory’s goals.

Choosing SciCord means choosing a company that values your business, understands your unique needs, and is dedicated to providing unparalleled support every step of the way. Join the SciCord family and experience the difference that true white-glove service can make in your laboratory’s operations.

Interfacing LIMS and ELN

Objective

This article aims to describe the division of functionality between ELN (Electronic Laboratory Notebook) and LIMS (Laboratory Information Management System) and the available interface options.

Why Interface LIMS and ELN

The functionality set represented by LIMS and ELN is desirable for pharmaceutical organizations with projects at or beyond phase III.  Compliance, traceability, sample management, and the sheer volume of data, render paper based documentation inadequate. Hardbound notebooks, Excel workbooks, and file shares are significant compliance risks just waiting to explode at every audit.

The best solution for a company transitioning from paper to an electronic system is to select a hybrid ELN plus LIMS solution.  The ELN and LIMS components in a hybrid solution are integrated by a single vendor and should provide optimum transparent communication.  Most organizations do not implement hybrid solutions for a few reasons:

1) Hybrid solutions combining best of class ELN/LIMS are rare.

2) The desirability of deploying both ELN & LIMS is not initially understood.

Typically, when confronted with phase III compliance challenges, organizations choose to deploy a LIMS.  Although excellent at organizing samples and results, LIMS does very little to reduce compliance/data volume issues at the bench.  To address these issues. ELN functionality is required.

Functionality Distribution

A critical decision is how to apportion the functionality between ELN & LIMS.  The criteria for distributing functionality:

• Group functionality used in a work session within one application to avoid users switching between systems. Switching between applications requires users to change mind sets to navigate different user interfaces.  Complex communication arising from the need to refresh data between the applications can be avoided by grouping tasks.
• Utilize the best aspects of each solution.

The table below illustrates an optimum distribution of functionality. The allocation attempts to create a contiguous workflow and utilize the strengths of each solution.

In general, administrative/management functions are allocated to LIMS with bench related processes encapsulated in ELN.   An underlying assumption guiding the division of functionality is that ELN will be readily available and active on laboratory benches.  Laboratory functionality has been grouped within ELN to take advantage of the readily available access and to avoid inefficient transitions between applications.  Allocation of functionality which is not self-evident is described in more detail below.

Configuration item definition and management (Methods, Analysis, Measurements) are handled by LIMS although these configuration items are used extensively by both ELN & LIMS.  LIMS is the natural placement for configuration.

Barcode functionality must be present in LIMS to support Sample Management and in ELN for chemicals, solutions, and standards. Implementing in both solutions does increase maintenance overhead.

Work Requests are the definition of the testing or other work to be accomplished on samples and includes visualization of the status of assigned work.  Work generated by stability or external sources is managed by LIMS while work originating internally is defined by ELN.  Interface of Work Requests is the most complex interface task.  The interface requires sharing user/group/site information in addition to sample/analysis/methods.

Chemical Inventory is allocated to ELN because the task is physically executed in laboratories.

Data File Management is provided by ELN unless an Enterprise Content Management solution is deployed for this purpose.

Notebook records, review, and lifecycle are consolidated in ELN.

Asset Management is a shared functionality.  LIMS provides equipment and instrument definitions while ELN records daily check and usage information.  The LIMS portion of Asset Management may be provided by a standalone Metrology application.

Interface Options

The interface options available are dependent on the two applications to be interfaced.  Web Services, database views, file transfer are among the available options.

Web services are utilized to expose the persisted data of an application.   Web Services are interoperable (language independent), provide a standardized protocol, and represent an economical form of communication.  For these reasons, Web Services are by far the best option available and will be the focus of this discussion.

The diagram represents the data objects which must be exposed as a data service from both ELN & LIMS.  Additionally, each system must be configured to consume the exposed data objects.

Data Refresh

Refresh of interfaced data is a critical component of the ELN & LIMS interface.  Polling of the current state of exposed data is required each time an operation in one system requires data from the other.  Polling determines if the data is stale and requires refresh.   The complexity involved in polling and refresh is governed by:

• Frequency of the consuming operation requiring the exposed data.
• Variability of the exposed data.

The matrix diagram above identifies projected use and variability for each type of exposed data.  Variability is measured in number of times a table is expected to change per day, where low is several changes each day and high is 10 changes or more each day.

In situations with low variability tables, refresh for each usage by the consuming application is not required.   The consuming application (ELN) can simply poll to determine if a change has occurred and refresh only when necessary.

In situations with high variability, it must be assumed that the data is often stale and requires refresh.  The high variability data defined above is ELN Results, ELN Sample Status, and ELN Work Requests. This data is consumed by LIMS activities such as reports and trending which are less frequent operations.

Summary

Interface between ELN and LIMS is often required for business reasons and to obtain best of class functionality.  Division of functionality between ELN & LIMS is critical to avoid complexity and increase usability.  Web services provide the optimum interoperability and standardization necessary for a successful interface.

Streamlining Scientific Collaboration

In today’s rapidly evolving scientific landscape, researchers face growing demands to collaborate and share data across institutions. However, traditional paper-based lab notebooks, essential for scientific record-keeping, can be cumbersome and time-consuming to manage and share. SciCord Informatics offers a digital lab notebook designed to enhance how scientists collaborate and conduct research.

How ELNs improve laboratory collaboration

SciCord’s digital lab notebook provides researchers with a secure and user-friendly platform for capturing, storing, and sharing their research data. The platform is designed to be flexible, accommodating into all types of laboratory workflows and accommodating into existing lab infrastructure. This makes it easy for researchers to transition from paper-based to digital record-keeping, without disrupting their existing processes.

One of the key features of SciCord’s platform is its ability to facilitate collaboration. With SciCord, researchers can easily share their data with colleagues both within and outside of their institutions, enabling them to work together on projects and analyze data in real-time. Additionally, the platform allows for multiple people to access and edit the same notebook simultaneously, eliminating the need for multiple copies and ensuring that all team members have the most up-to-date information. SciCord Informatics also offers advanced tools for data analysis and visualization, enhancing users’ ability to interpret and report their findings efficiently. This includes automated data capture, analysis, and reporting, which streamlines workflows and reduces the likelihood of human error.

Another major advantage of SciCord’s digital lab notebook is its ability to improve data security and compliance. With traditional paper-based lab notebooks, data can be easily lost, stolen, or destroyed. With SciCord, all data is securely stored in the cloud and can be easily backed up and recovered in case of an emergency. Additionally, the platform is compliant with various regulations including FDA 21 CFR Part 11 and GxP, which makes it ideal for use in regulated industries such as pharmaceuticals and medical devices.

SciCord also ensures detailed audit trails, providing transparency and traceability which are critical for audits and compliance with industry regulations. The platform’s standardization ensures consistent documentation practices across the organization, which is important for maintaining quality and compliance.

In addition to collaboration and security, SciCord’s digital lab notebook also improves data management and accessibility. With traditional paper-based lab notebooks, data can be difficult to search, sort, and analyze. With SciCord, researchers can easily search and retrieve their data using keywords, dates, or other parameters. Additionally, the platform allows for data to be exported in a variety of formats, making it easy to integrate with other software and analytical tools.

Additionally, SciCord’s ELN supports integration with various instruments and external systems (e.g. Empower), creating a seamless data ecosystem. This interoperability enhances productivity and ensures that data flows smoothly across different platforms and tools.

SciCord’s digital lab notebook is also designed to be mobile-friendly, allowing researchers to access and update their notebook from anywhere, at any time. This is especially useful for researchers working remotely or in the field, as they can easily capture and share data in real-time.

A step in the right direction for labs

In conclusion, SciCord’s digital lab notebook represents a significant step forward in the way scientists collaborate and conduct research. Its ability to facilitate collaboration, improve data security and compliance, enhance data analysis and visualization, support integration with other systems, and improve data management and accessibility make it an essential tool for any modern laboratory. With SciCord Informatics, researchers can easily capture, store, and share their data, enabling them to work more efficiently and effectively, and ultimately, accelerate the pace of scientific discovery.

Ensuring Compliance: The Crucial Role of FDA Regulations for ELNs and LIMS in the Pharmaceutical Industry

In the rapidly evolving landscape of scientific research and development, Electronic Laboratory Notebooks (ELNs) and Laboratory Information Management Systems (LIMS) have become essential tools. They offer a convenient and efficient way to store, manage, and analyze data, thereby enhancing productivity and accuracy in laboratories. However, in the pharmaceutical industry, the utility of these systems extends beyond mere data management; compliance with regulations set by the Food and Drug Administration (FDA) is paramount.

I. The Importance of Compliance

The FDA enforces strict regulations to ensure the safety, efficacy, and quality of pharmaceutical products. Compliance with these regulations is critical for several reasons:

1. Ensuring Data Integrity and Traceability:

• Data Integrity: Accurate and reliable data is the cornerstone of pharmaceutical research and development. Compliance with FDA regulations ensures that data is recorded, processed, and maintained in a manner that preserves its integrity.
• Traceability: Regulatory compliance mandates detailed audit trails, which are essential for tracking the history of data and ensuring traceability. This is crucial for identifying any deviations and implementing corrective actions.

2. Meeting Regulatory Requirements:

• 21 CFR Part 11: This FDA regulation outlines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Compliance with 21 CFR Part 11 is mandatory for ELNs and LIMS used in regulated environments.
• Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP): Adhering to GLP and GMP guidelines ensures that laboratory practices and manufacturing processes meet the required quality standards.

3. Facilitating Regulatory Inspections and Audits:

• Readiness for Audits: FDA inspections and audits are routine in the pharmaceutical industry. Compliance with regulatory standards ensures that laboratories are always prepared for inspections, thereby reducing the risk of non-compliance penalties.
• Transparency: Maintaining detailed and accurate records in ELNs and LIMS enhances transparency and facilitates smoother audits.

II. Key Features of Compliant ELNs and LIMS

To meet FDA regulations, ELNs and LIMS must incorporate several key features:

1. Secure Data Storage and Access Control:

• User Authentication: Robust user authentication mechanisms are essential to ensure that only authorized personnel can access the system.
• Access Controls: Role-based access controls help in defining user permissions, ensuring that data access is restricted based on the user’s role and responsibilities.

2. Audit Trails:

• Detailed Logs: Comprehensive audit trails that record all data entries, modifications, and deletions are critical. These logs must be immutable and easily retrievable for audit purposes.
• Time Stamps: Accurate time stamps are necessary for all electronic records to ensure traceability and accountability.

3. Electronic Signatures:

• Compliance with 21 CFR Part 11: Electronic signatures must be implemented in accordance with FDA guidelines, ensuring that they are as reliable and trustworthy as handwritten signatures.
• Signature Records: Systems must maintain records of electronic signatures, including the name of the signer, the date and time of the signature, and the purpose of the signature.

4. Data Encryption and Backup:

• Encryption: Sensitive data must be encrypted both in transit and at rest to protect against unauthorized access and data breaches.
• Regular Backups: Regular data backups are essential to prevent data loss and ensure data recovery in case of system failures.

5. Validation and Verification:

• System Validation: ELNs and LIMS must undergo rigorous validation to demonstrate that they function correctly and meet all regulatory requirements.
• Regular Reviews: Continuous monitoring and regular reviews of the systems are necessary to ensure ongoing compliance.

III. The Path Forward

As the pharmaceutical industry continues to embrace digital transformation, the adoption of ELNs and LIMS will only increase. However, with this technological advancement comes the responsibility of ensuring that these systems comply with FDA regulations. By doing so, laboratories can not only enhance their efficiency and productivity but also safeguard the integrity and reliability of their data.

IV. Conclusion

Compliance with FDA regulations is not just a legal requirement but a fundamental aspect of maintaining high standards in pharmaceutical research and manufacturing. ELNs and LIMS that meet these regulatory standards provide a robust framework for data management, ensuring data integrity, traceability, and security. As such, they are indispensable tools for any pharmaceutical laboratory committed to achieving excellence in their scientific endeavors. By prioritizing compliance, laboratories can confidently navigate the complexities of the pharmaceutical industry and contribute to the development of safe and effective medical products.

Sample Management

Sample management is a crucial aspect of any laboratory system. It allows researchers to effectively track, organize, and store samples throughout the experimental process.

Benefits

One of the main benefits of sample management in a digital tool is increased organization and efficiency. With the ability to track samples from acquisition to disposal, researchers can easily access and reference important information about each sample, such as its origin, storage conditions, and any relevant notes or observations. This can greatly streamline the experimental process, allowing researchers to quickly and easily locate and utilize the samples they need.

Additionally, sample management systems provide real-time tracking and automated data entry, reducing the risk of human error and ensuring that all sample information is always up-to-date. This automation not only saves time but also improves the accuracy of data management. Automation features can include barcode scanning, automatic inventory updates, and integration with other laboratory systems, which collectively enhance workflow efficiency.

Another benefit of sample management in a digital tool is improved data integrity and compliance. By storing all information about a sample in a centralized, electronic location, researchers can ensure that data is accurate, complete, and easily accessible for audits or inspections. This can help to ensure compliance with regulations and guidelines, such as Good Laboratory Practice (GLP) or Good Clinical Practice (GCP).

Detailed audit trails within sample management systems provide a complete history of sample handling, ensuring transparency and traceability. This is crucial for maintaining regulatory compliance and upholding data integrity. These audit trails can log every action taken on a sample, from its initial entry into the system to its final disposal, capturing user IDs, timestamps, and specific changes made.

In addition, sample management in a digital tool can also facilitate collaboration and sharing of samples among different researchers and groups. With the ability to easily access and share sample information, researchers can more easily collaborate on projects and share samples, which can greatly enhance the overall productivity and success of research efforts. Collaboration features may include shared databases, real-time updates, and notifications, ensuring that all team members are informed about the status and availability of samples.

Furthermore, advanced search functionalities enable researchers to quickly locate samples using various parameters such as sample ID, date, type, or storage location. Efficient inventory management tools help monitor sample quantities and expiration dates, reducing waste and optimizing resource use. These tools can also automate reordering processes, ensuring that critical samples are always in stock.

Mobile integrations can offer sample managers increased flexibility when updating sample information, including leveraging cell phone cameras for barcode scanning, enabling real-time updates and streamlining data entry processes. This mobile capability ensures that sample data can be managed on the go, increasing efficiency and accuracy in dynamic laboratory environments.

Scalability is another significant advantage, as sample management systems can adapt to the growing needs of the laboratory, accommodating increasing sample volumes and more complex workflows. Whether a laboratory is expanding its operations or diversifying its research activities, a scalable sample management system can support these changes without compromising performance.

Finally, cost efficiency is achieved through reduced waste and optimized resource utilization, resulting in overall savings and improved operational efficiency. By minimizing sample loss and maximizing the use of available resources, laboratories can significantly lower their operational costs.

Conclusion

Overall, sample management in a digital tool can greatly improve the organization, efficiency, compliance, and collaboration of laboratory operations. With advanced features such as real-time tracking, automated data entry, seamless integration, and mobile accessibility, it is an essential tool for any laboratory looking to streamline their work and achieve better results. Effective sample management is fundamental to modern laboratory practices, ensuring that valuable samples are handled with utmost care and precision, ultimately enhancing productivity and operational success. Additionally, the integration of advanced technologies and compliance features ensures that laboratories can meet regulatory standards and maintain the highest levels of data integrity.

Does Your ELN or LIMS Help Your Lab Be FDA 21 CFR Part 11 Compliant?

Whether you’re selecting your first ELN/LIMS or evaluating the effectiveness of your current digital solution, you need to verify that it meets the United States Code of Federal Regulations (CFR) Part 11 as it applies to a pharmaceutical lab that produces and utilizes electronic documents and signatures. Since 1997, Part 11 of Title 21 of the Code, has been the primary authority governing the standard of practice for electronic records. Pharmaceutical laboratories that plan on adopting digital solutions for documentation should ensure that the ELN or LIMS solution they are selecting is one that is FDA 21 CFR part 11 compliant.

In this article, we explain several key provisions of FDA 21 CFR Part 11 and answer commonly-asked questions.

What made 21 CFR Part 11 a necessity?

What are the operational purposes of 21 CFR Part 11?

The operational purposes of 21 CFR Part 11 focus, first, on granting access to documents only to authorized individuals who are properly identified and who meet access requirements. The second purpose of 21 CFR Part 11 is to safeguard data integrity by creating strong security measures that include strict password, login, and electronic signature protocols as well as a clear audit trail that monitors all changes to a record and enhances a lab’s ability to catch errors or detect unauthorized access to any document.

Which industries need to comply with 21 CFR Part 11?

There are a few exceptions, but generally, US companies that manufacture pharmaceuticals, food products, or medical devices must adhere to 21 CFR Part 11.

What are the 3 main parts of 21 CFR part 11?

1. General provisions. This section lays out the overall scope of the regulation and explains the types of documents to which it pertains.

2. Electronic records.

• Data Integrity: Ensuring that electronic records are accurate, complete, and reliable.
• Traceability: Maintaining a traceable link between records and their respective electronic signatures.
• Secure Storage: Implementing robust security measures to protect records from unauthorized access, alteration, or deletion.
• Audit Trails: Maintaining detailed logs of all changes to records, including who made the change, what the change was, and when it occurred.
• System Validation: Conducting rigorous validation to demonstrate that the informatics solution meets all regulatory requirements.

3. Electronic signatures.

• Verification: Ensuring each person’s identity is verified and assigning unique electronic signatures.
• Signature Linking: Associating electronic signatures clearly with their respective records, including date and time stamps and the role connected to each signature.
• Non-repudiation: Implementing measures to prevent electronic signatures from being repudiated.

What qualifies as an “electronic document”?

• The whole “life” of the document. Any file created with a computer system falls under 21 CFR purview. So does every iteration of the file, regardless of how many times it is “modified, maintained, archived, retrieved or distributed.”
• Any record–even a single file. Even if your company creates only one electronic document, you’re obligated to comply with 21 CFR Part 11.

How does the SciCord Informatics platform help you be 21 CFR Part 11 compliant?

The SciCord Informatics platform features a spreadsheet-based hybrid ELN/LIMS 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.

Summary

Complying with all the requirements of 21 CFR title 11 can be tedious unless you have a robust ELN or LIMS solution in place. The specifications regarding the safety and integrity of electronic records, including electronic signatures and an audit trail, can be onerous. SciCord Informatics platform meets all the 21 CFR Part 11 compliance requirements and provides a hybrid solution for data integrity and safety. By ensuring compliance with these regulations, laboratories can enhance their efficiency, accuracy, and security in managing electronic records and signatures.

SciCord Benefits within the Lab

SciCord Informatics provides laboratories with a hybrid ELN and LIMS solution that offers the flexibility of an ELN with the structure of a LIMS. When asked, scientists that operate at the bench like to use SciCord because of the user-friendly interface, the integration of ELN and LIMS functionality, collaboration with colleagues, compliance aspects, data visualizations, customizability, and the fact it’s a cloud-based service.

User-Friendly Interface: SciCord has a user-friendly interface that allows scientists to easily manage and organize their experiments and data. The platform is designed to be intuitive and straightforward, making it easy for users to get started and quickly become productive.

Integration of ELN and LIMS: SciCord Informatics provides a single platform that features electronic laboratory notebooks (ELN) and laboratory information management systems (LIMS), which can help streamline the workflow of scientists. This integration enables researchers to manage their data and experiments in one place, eliminating the need for multiple tools and reducing the risk of data loss or inconsistencies.

Collaboration: SciCord provides a range of collaboration features that make it easy for scientists to work together on experiments and projects. Researchers can share their data and results with colleagues, and use the platforms audit and commenting features to track changes and discuss findings.

Compliance: SciCord has built-in security and compliance features to help ensure that sensitive research data is stored and shared securely. The platform is designed to meet industry regulations and standards (FDA 21 CFR Part 11 / GAMP), and can be customized to meet the specific needs of individual organizations or projects.

Data Visualization: SciCord provides tools for data visualization, which can help scientists quickly identify patterns and trends in their data. This can save time and improve the accuracy of research results, as well as make it easier to communicate findings to others.

Customizability: SciCord provides a range of customization options, allowing scientists to tailor the platform to meet the specific needs of their organization or project. This can include customizing the layout and functionality of templates that simplifies the experiments into easy-to-follow processes.

Cloud-Based: SciCord is a cloud-based platform, which allows scientists to access their data and experiments from anywhere with an internet connection. This can be especially useful for researchers who need to work remotely or travel frequently.

Real-Time Tracking and Automated Data Entry: SciCord offers real-time tracking and automated data entry features, ensuring that all sample information is always up-to-date and accurate. This automation reduces manual input errors and saves time.

Advanced Search Functionalities: SciCord’s advanced search functionalities enable scientists to quickly locate specific data or samples using various attributes, such as sample ID, date, type, or storage location. This capability greatly enhances efficiency and productivity.

Mobile Accessibility and Barcode Scanning: SciCord’s mobile-friendly platform allows researchers to access and update data from anywhere, enhancing flexibility and responsiveness. The ability to use cell phone cameras for barcode scanning simplifies sample tracking and data entry.

Seamless Integration with Other Systems: SciCord integrates seamlessly with analytical instruments and systems, creating a cohesive data ecosystem and improving overall laboratory efficiency.

Scalability: SciCord is designed to scale with the needs of the laboratory, accommodating growing data volumes and more complex workflows, making it adaptable for various research and manufacturing environments.

Cost Efficiency: By optimizing resource use and reducing waste through efficient sample and inventory management, SciCord helps laboratories achieve significant cost savings and improve operational efficiency.

 

In conclusion, SciCord offers a comprehensive solution for scientific data management and collaboration that can help bench scientists streamline their work and improve the accuracy and security of their research results. With advanced features like real-time tracking, automated data entry, advanced search functionalities, and seamless integration, SciCord enhances the efficiency and effectiveness of laboratory operations. With its user-friendly interface, integration of ELN and LIMS, collaboration features, compliance options, data visualization tools, customizability and cloud-based architecture, SciCord can be an excellent choice for researchers looking to improve the efficiency and effectiveness of their work.

Introduction

By all accounts, “Cloud Computing” lowers the total cost of ownership of IT for companies in industries of any type and of any size.  In marked contrast to other industries, the Pharmaceutical industry has lagged in adopting cloud computing solutions, retaining costly on-premise solutions or implementing hybrid Cloud solutions which deliver only minimal benefit. Data integrity, among other barriers to implementation, remains the major hurdle for the Pharmaceutical Industry in attempting to adopt Cloud technology.

In 2014 the Food and Drug Administration published an article in the FDA Voice praising how leveraging Cloud Computing allowed the Agency to “continue to protect and promote the public health”. In early 2016, the FDA followed-up by publishing “Guidance on Data Integrity”, which, for the first time, clearly categorized a computer system: “Computer or related systems can refer to computer hardware, software, peripheral 142 devices, networks, cloud infrastructure, operators, and associated documents (e.g., 143 user manuals and standard operating procedures)”.

About the same time the FDA was publishing its “Guidance on Data Integrity”, the Internal society for Pharmaceutical Engineering (ISPE) formed a new GAMP (Good Automation Manufacturing Practices) Special Interest Group with the intent to provide guidance on the usage of Cloud technologies in the regulated (GxP) environments and to help accelerate the adoption of this technology within the industry.

Implement a Cloud solution

There are 3 main delivery models for Cloud solutions, which can be implemented using virtual online products instead of physical on-site hardware: Infrastructure as a Service (Iaas), Platform as a Service (Paas) or Software as a Service (SaaS). The responsibilities for using any of these delivery models as GxP solutions are comparable to utilizing any traditional on-site IT model and they all apply similarly.

Depending on the used cloud model – Infrastructure as a Service (Iaas), Platform as a Service (Paas) or Software as a Service (SaaS) – the nature of some of these responsibilities, however, might change.

The true benefits of Cloud computing are specialization and focus.  Scientific organizations want to focus on science and view IT as necessary to supporting infrastructure.  By contrast, vendors focus and specialize exclusively on IT solutions, spreading the development and support costs across their entire customer base.

From the diagram, it is evident that there is a transfer of effort from the scientific organizations onto vendors as the SaaS Cloud delivery model is more fully implemented.  SaaS describes a delivery model in which the IT effort is almost completely transferred to the solution vendor and describes the most beneficial end-state for scientific organizations.

Under this well-established model, customers who intend to use Cloud products as part of their GxP systems must assess responsibilities covered by Quality Systems, System Development Life Cycle and Regulatory Affairs areas.

Management Responsibility

Involves tasks such as creating and managing user accounts within the system, ensuring access controls are appropriately managed and maintained.

Personnel

Focuses on ensuring that all personnel interacting with GxP systems have the necessary qualifications, training, and experience to perform their assigned roles effectively and compliantly.

Audits

Regular assessments conducted to evaluate the effectiveness of security measures, data integrity controls, and overall compliance with regulatory standards. Audits ensure that systems are operating as intended and that any issues are promptly identified and addressed.

Product Assessment

Ensures that all products and components used within GxP systems meet predefined specifications and quality standards. This assessment is crucial to maintaining the integrity and reliability of data generated by these systems.

Supplier Evaluation

Involves assessing and selecting suppliers, contractors, and consultants based on their ability to meet specific GxP requirements. This process ensures that external partners contribute to maintaining compliance and system integrity.

Supplier Agreement

Establishes clear responsibilities and commitments between organizations and their IT suppliers. This includes obligations to notify about any significant changes to IT products or services that could impact GxP operations.

Records & Logs

Identifying and maintaining necessary records and logs as evidence of GxP compliance throughout their required retention periods. This ensures data integrity and traceability for audits and regulatory inspections.

System Development Life Cycle

Each GxP system must have certain features and a controlled SDLC process for delivering them. The specific features and SDLC controls that apply to each system depend on a variety of factors and are derived from regulations like 21 CFR Parts 11 and 820 in the US, Annex 11 and 93/42/EEC in the EU, and their international equivalents. The overall intent of these regulatory guidelines is to ensure that the GxP system fulfills its intended use and that the data is trustworthy and reliable.

Develop

GxP systems need to be developed following documented procedures that ensure the systems meet their specified requirements. Development activities include: planning, coding, building, configuring, testing, and deployment.

Validate

GxP applications need to be validated to ensure that software specifications conform to user-needs requirements, and the software infrastructure that the GxP applications runs on needs to be qualified to ensure that it meets the system requirements for the application.

Operate

Developing, conducting, controlling and monitoring GxP systems in production operations is important to ensure that they continue to conform to specifications. When end-user issues or system deviations occur, organizations with GxP systems also need to maintain a process for responding, correcting and preventing those issues.

• Change Control
• Service Level Agreement (SLA)
• End User Support
• Back and recovery
• Incident Response
• Corrective and Preventive Action (CAPA)

Conclusion

With the Cloud, organizations of any size can take advantage of solutions that will minimize the total cost of ownership, ensure pharmaceutical data integrity, and remove the need to plan and procure physical devices and IT infrastructure weeks or months in advance.

Cloud Validation is certainly a challenge, however following FDA and GAMP guidance many organizations are demonstrating that it is possible to utilize the Cloud in GxP regulated environment and thus secure the benefits that this innovative technology offers.