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ChemSW’s Enterprise software solutions, such as CIS Chemical Inventory System® CISPro and STIS™ Sample Tracking and Inventory System, provide audit trail and electronic signature to meet 21CFR11 compliance. Our systems incorporate multiple levels of security, transaction logging and signature verification ideal for use in pharmaceutical and biotech laboratories.
Below you will find links to aid you in understanding 21CFR11, the latest news, and how software tools can help meet that or any GMP, cGMP, or GxP requirement.
21 CFR Part 11 refers to the Code of Federal Regulation the FDA issued in March of 1997 (see below) that “sets forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”1 This was established as a part of the FDA’s current good manufacturing practices (cGMP) for the production and development of human and animal drugs and biologics.
If you would like more information about our 21 CFR Part 11 products please contact us at 707-864-0845 or info@chemsw.com
Latest News on 21 CFR Part 11
Important Links:
¹ 21 CFR Part 11, 11.1 (a)
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