21 CFR Part 11 compliance – PDF & Key Things to Know
5 min read
SciNote is a trusted solution used by the researchers at the FDA. In this article, we have listed critical details about FDA 21 CFR Part 11 compliance on electronic records and electronic signatures.
Historically, companies maintained a paper trail of all their equipment, experiments and results in order to comply with the current GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) regulations. Today, with the increasing amount of digitalization and automatization, the volume of digital data created and transferred has rapidly surmounted what is still feasible to maintain in paper records. This situation calls for a radical switch from paper records to digital records.
With this in mind, many regulatory agencies have set out policies regarding electronic records; one of such examples is the FDA 21 CFR Part 11. If your lab requires compliance with CFR Part 11, GMP, or GLP, an electronic lab notebook (ELN) could be a great tool to support your switch from paper to digital.
Meeting 21 CFR Part 11 compliance requirements
In a regulated environment, digital information is governed by FDA 21 CFR Part 11 in the US (or EU Annex 11 within the European Union). This is a set of instructions and guidelines about the creation, authentication and maintenance of digital records.
Compliance is a complex and resource-consuming process, it’s not limited to just buying and installing a “21 CFR Part 11 compliant” software. The whole electronic systems for keeping records needs to be verified – and only when all the pieces of the puzzle are linked together, the laboratory can say it is 21 CFR Part 11 compliant.
Get your 21 CFR part 11 compliance PDF guide
SciNote supports electronic signatures, electronic witnessing, audit trails and more.
If your lab needs to comply with 21 CFR part 11, GLP or GMP requirements, this is the PDF for you.
SciNote & FDA Webinar: Lab software and compliance
If you are looking for a software for your lab that will help you meet the compliance requirements, watch our webinar with the FDA where we cover:
- Technical aspects, setting up computer systems, making sure that they work, looking at capabilities of the software solutions etc.
- How to acquire a software for your lab and meet the compliance requirements?
- Q&A session
Key things to know about FDA 21 CFR Part 11
In order to comply with 21 CFR Part 11, you must take into account 4 important things:
1. The hardware and software you use must be validated in order to prove that all the equipment is fit for its intended use.
Validation is connected with the second important feature, the SOP’s (Standard operating procedures), they are instructions on what must be done in case something does not conform to the specifications.
2. All regulated environments are based on SOPs.
This is the second key element to complying with regulations. In SOPs, all the processes regarding data generation and storage need to be defined and described. Some of the SOP’s in a typically regulated environment include computer and network system maintenance, as well as backups and restoring of backup data. Other key SOPs are for introducing changes to the system with new equipment, system data security and recovery of data in case of catastrophic events.
3. Instruments, users or user accounts and additional features must be described to comply with 21 CFR Part 11.
The transition from paper records to digitally signed electronic records entails the following steps. The SOPs required for instrument operation, computer & network management and electronic signature management need to be prepared. All users need to have personal login credentials to enable unique signatures of documents. Software that supports 21 CFR Part 11 compliance needs to be installed and then verified on your network system; including software for managing instruments and devices, electronic lab notebook and laboratory inventory management software.
4. Of course, all records need to be computer readable and human-readable.
Once a electronic record is created and signed, it needs to be protected against change. All data operations need to be recorded in an audit trail.
The move toward digital records for compliance requirements has started, and it won’t slow down in the future. Act now to start your move toward digital records, and see how SciNote can help you address your compliance needs.
If you like this post, also check out
- Data Integrity in your lab: The 6 steps you can take to avoid an FDA warning
- The value of an electronic lab notebook – on ROI and stakeholder buy-in
- SciNote example of use: GMP lab working with clients
- Data Integrity and Compliance With Drug CGMP: Questions and Answers – FDA
- Part 11, Electronic Records; Electronic Signatures – Scope and Application – FDA
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