21 CFR Part 11…what it is….and why it matters for ALL FDA regulated industries….present and future

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21 CFR Part 11…what it is….and why it matters for ALL FDA regulated industries….present and future

operator in the pharmaceutical factory near the equipment, electronic signature approvals

Just what is this 21 CFR Part 11?

21 CFR (Code of Federal Regulations) Part 11 established electronic records and signatures for FDA regulated industries.

While standardizing guidelines, the code importantly improves documentation and operational efficiency in use.

21 CFR Part 11 compliance brings the following benefits:

  • Increased data confidentiality, integrity, and accessibility
  • More paperless environments
  • Faster information exchange
  • Increased cost savings from reduced information storage space
  • Reduced errors

From the pandemic experience, the advantages these offer to health-related product development simply cannot be overstated. When this work suddenly became remote, cloud-based 21 CFR Part 11 systems continued the progress toward vital remedies…….proving their worth.

Here is a brief review of key elements of 21 CFR Part 11:

  • User Authentication—verifies the identity and uniqueness of logins
  • Security—allows only authorized user access; secure storage; and transmission of information without meaningful interception.
  • Auditability—ability to ensure the trustworthiness and reliability of record activity through observable login identity and date/time information
  • Record Management—generation and retention of human intelligible and electronic records for inspection, review and copying
  • System Validation—proof of proposed system installation, operation, and performance through a series of successfully completed test scripts and procedures

At InstantGMP, these Part 11 items are the design criteria for all of our software systems, as well as our SOPs. For example, all InstantGMP systems, upgrades, etc., have completed an automated OQ per part 11 guidelines. We do this in house. We can assist in PQ upon request. This eliminates the need for any supplemental validation “package” or third-party involvement, for the use of our software.

Pharma or biotech producers tend to understand the code well. It’s less familiar, but no less important, for dietary supplements and other regulated domains, present and future. Its implications provide some clear advantages:

  • Inspections-production events that confirm user/time signoffs for permissions, approvals, etc. can greatly expedite audits. This can also improve a GMP certification process as well as a full-fledged FDA (or equivalent) review.
  • Customer review and retention-InstantGMP has designed in customer e-view and e-approval of production; our Make to Order Batch Record simplifies ‘build from scratch’ products and processes; and the InstantGMP PRO system adds interactive collaboration on documents for business and technical applications. All built “per code”.
  • Strategic business objectives-proof of Part 11 operation can win product shelf space from discerning wholesalers and retailers…..and end user confidence. It’s a respected standard and a statement of commitment, especially in domains that have experienced recalls and citations. A well-made Electronic Batch Record can be an effective product resume.

We at InstantGMP plan to keep on bettering compliance to 21 CFR Part 11 through ongoing development. That’s our job. We welcome your inquiries.

To learn more about our GMP software products, validation process or to schedule a demonstration, please contact our team today!

21 CFR Part 11, Electronic Records and Electronic Signatures