21 CFR Part 11: A Brief Overview of cGMP
Manufacturing companies in the life sciences must follow FDA 21 CFR 11 and EU GMP Annex 11 requirements in order to sell products in the US and EU. As many organizations across the industry scale up production from clinical to commercial operations, adequate documentation and access to records is essential. In a growing and more competitive market, faster product releases and streamlined FDA audits are a must. While adhering to this regulation may seem daunting, electronic record keeping becomes a no-brainer.
The largest hurdle to successful documentation is paper! Paper records pose risks around legible handwriting, accountability, signatures, and more. These compliance risks demonstrate that paper is not always the solution to record keeping. Paper can take days, weeks, and even months to reach an report for investigations and process improvement. This can result in fines, costly delays, and improper data entry. Electronic systems have been built to alleviate these risks and provide high value functionality within many use-cases, particularly around logbooks, batch records, forms, and work activities. Going electronic helps to solve some of these challenges. The US FDA and EU have developed GMP guidance, 21 CFR Part 11 and Annex 11, for electronic record keeping and signatures in the pharmaceutical, biotech, life sciences, cosmetics, and medical devices industries.
What is 21 CFR Part 11?
First established in 1997, this regulation requires electronic records and signatures to ensure documentation is trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. In order to follow 21 CFR Part 11, GMP compliant software must be used to manage such activities for accountability. Electronic records and signatures must include the relevant details surrounding the activity captured and all changes. Data in the records must be authenticated as belonging to the person performing an activity.
21 CFR Part 11 includes three main sections:
General Provisions Key Points:
Accountability is key in pharmaceutical manufacturing, in areas governed by 21 CFR Part 11. Records must clearly identify the who/what/when/where/why of all activities involved with a process. GMP Compliant Software must enable a system of record so that such documentation is trustworthy, reliable, and equivalent to the documentation typically found on paper. Further, the documentation must be readily available for use in FDA Audits and inspections.
Electronic Records Key Points:
Managing paper records is a daunting task. Paper is limited in that it is challenging to control the execution. Electronic systems, and in particular, GMP software, must limit access to authorized users. This enables a high degree of control over accessibility for authorization. Ultimately, ensuring that the right person, performs the right activity, at the right time.
GMP Audit Trails are necessary as they not only capture activities performed, but also all revisions and changes to the process. The audit trail ensures full traceability within this process, something that paper simply cannot do.
Audit trails not only capture who performs the activities, but also the surrounding details, such as the time and date, and the meaning of the action. This is essential in GMP operations. The audit trail captures all changes, in all states. Such a process eliminates the risks of falsification to ensure compliance with GMP regulations.
Electronic Signatures Key Points:
The electronic signature is essential in maintaining accountability. GMP Systems, for use in pharma biotech, and so on, provide unique credentials to all those interacting with the process. Credentials cannot be reassigned or re-used by others. Typically, a username and password combination control the security and integrity of an authorization.
Additionally, the identification must include several details for full accountability. These details include the users name (username or user ID), the timestamp of the action, as well as the meaning of the action. This validates not only the identity of the performer, but also the meaning of the activity.
How Does OpsTrakker Help With 21 CFR Part 11 Compliance?
When assessing different electronic solutions, selecting one compliant with 21 CFR Part 11 is essential. OpsTrakker was built with GMP in mind to deliver the requirements necessary for user identification, authorization, traceability, and reliability. OpsTrakker equipment management, forms, and documentation solutions can help ensure that your organization, achieves the highest-level of performance, without sacrificing GMP compliance. The audit trail appropriately captures all activities in real-time and logs all changes accordingly.
You can learn more about 21 CFR Part 11 for electronic records and signatures here: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
We understand the importance of GMP to all pharmaceutical organizations. Our life science consulting team will ensure the delivery of a GMP complaint system to exceed your needs. Get in touch to learn more about how OpsTrakker’s solutions can support your digital transformation.
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