The Part 11 Advisor assesses your compliance with
21 CFR Part 11, Electronic Record and Electronic Signature systems, creates Corrective Action Plans, and tracks progress towards compliance.
As the 21 CFR 11 FDA increases enforcement of 21 CFR 11, it is more important than ever that FDA-regulated businesses ensure that their systems are compliant with all of the provisions of 21 CFR 11, Electronic Records Electronic Signatures.
The Part 11 Advisor is an efficient and effective tool for you to ensure that all of your computer systems are compliant with 21 CFR 11. Part 11 Advisor facilitates the creation of computer system inventories and guides you through the process of assessing the compliance status of each system. If you determine that any of your computer systems are not fully compliant, Part 11 Advisor helps you create Corrective Action Plans to address any compliance gaps, including suggesting remedies to meet shortcomings in compliance.
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