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| System Architecture | 21 CFR Part 11 | Consulting | Project Management | e-Commerce | Industries & Disciplines | Contact Info | |||
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If you research, test or manufacture a drug, a nutritional supplement or a medical device under the regulatory oversight of the FDA, you have certain requirements for recordkeeping under the predicate rules covering what you make. For example, in the drug manufacturing industry, you are covered by 21 CFR Parts 210 & 211. |
As an adjunct to this, you may decide to keep some or all of your required records electronically. This subjects you to the regulations in 21 CFR Part 11. I have been involved from the beginning with the creation of a product intended to simplify the maintenance of low-volume records in a compliant fashion. |
In the course of this work, I was able to factor out a generic list of requirements for any system to be compliant with 21 CFR Part 11. I have developed this into a manuscript for an e-Book that will be available soon (watch here for details as they become available). | |||||||
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MAAYA |
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