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.