FDA 21CFR Part 11 Regulations

Kallik minimizes the impact of staying compliant with current and forthcoming pharmaceutical regulations

What is 21CFR Part 11

21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Each title of the CFR addresses a different regulated area, 21 CFR relates to Pharmaceuticals and Medical Devices and Part 11 being applicable to electronic records and electronic signatures.

How does Kallik help with the DSCSA?

Kallik’s software helps regulated industries ensure that their labelling processes are compliant with 21CFR Part 11 through the capture, recording and publishing of audit reports that can be used as part of their due diligence and reporting processes to evidence adherence to GMP guidelines.

  • Is fully compliant with 21CFR Part 11 including audit trail functionality, electronic signatures, security and data integrity,  records retention and file formats
  • Enables organizations to move from wet ink to digital signatures eliminating the risk of lost or falsified records that could otherwise result in non-compliance and potential fines
  • Provides comprehensive details of users accessing the labeling solution the tasks undertaken with detailed logs that can be used as part of any subsequent audit

Timeline of Updates

Early 1991: Requirements established

Key groups who operated within the pharmaceutical industry met the FDA to determine how the industry would deal with electronic record keeping systems that fell within GMP regulations.

August 1997: Final Rule published

Over the next few years these groups along with the FDA started to build out the early versions of the rules we are governed by today, with the final rule becoming effective on August 20th, 1997.

Beginning 2000: Electronic records in-use

From the year 2000, the FDA stated that alongside the released criteria, they would consider electronic records to carry the same compliance requirements as paper records and including electronic signatures as an equivalent to the traditional wet ink handwritten signatures. The FDA has released a number of guidance papers in response to the changing landscape to clarify the rule and how it should be interpreted.

2007: Final guidance published

In May 2007, the FDA issued the final version of their guidance on computerized systems in clinical investigations. This guidance supersedes the guidance of the same name dated April 1999; and supplements the guidance for industry on Part 11, Electronic Records; Electronic Signatures.

How To Be Compliant

Retire paper
Retire Paper-Based Processes

Reduce the cost of managing and recording the entire labelling lifecycle process by eliminating the need for paper-based records whilst reducing the overhead of responding to FDA audits.

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Demonstrate Adherence to GMP

Deploying a validated, enterprise labeling system with a secure audit log that captures the entire label lifecycle, including label printing will help demonstrate robust process and system validation at time of audit.

Reduce reporting overhead
Reduce Reporting Overheads

Look for a solution that automatically generates and stores records in such a way to ensure accurate and fast retrieval such that these can be found quickly and easily to minimize the burden of showing proof of compliance.

Accurate Print Reporting

In addition to original print production, label re-prints labels occur either due to error or quality issues.  It’s essential for 21 CFR Part 11 compliance that the labeling solution captures both the fixed and variable data along with identification.

Security control
Effective Security Controls

Ensure access is secure by requiring a unique log in and password for every user.  The labeling solution should support ‘permissions-based roles’ defining the specific tasks that each can perform, backed up by detailed reports of activity undertaken.

Comprehensive Digital Signatures

In order to be compliant with CFR 21 Part 11, look for a solution that stipulates that digital signatures must include printed name of the signer, the date/time the signature was applied, and the ‘meaning’ or intention of the electronic signature