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Validation requires to prove that each process involved in producing a product or result can be shown to be
- doing the right job
- and doing the job right
The validation of analytical systems is not an easy task. Validation is an ongoing process with strict (and often updated) regulation that evaluates the entire, sample specific process, products, and analytical methods.
Many lab managers associate validation with increased workloads and paper work, because it requires extensive documentation of all testing experiments. However, if the validation process is carefully and thoroughly planned, with method know-how, it indeed decreases documentation effort and ensures data integrity, traceability and security.
PSS offers dedicated and proven Compliance Services to assist our customers in reducing their regulatory risk and to streamline their compliance efforts.
Frequently Asked Questions
- FDA21CFR Part 11
What are the main requirements of 21CFR part 11 for electronic records and electronic signatures?
For customers working in an FDA regulated environment, it is necessary that the software is compliant with regulations adopted by the FDA. These regulations are contained in the Code of Federal Regulations (CFR), Title 21, Part 11, and are entitled “Electronic Records; Electronic Signatures”. These rules change significantly the treatment of computer-generated data. The main goal of this rule is securing the authenticity of the generated analytical data and protection against unauthorized disclosure, unintentional error and intentional fraud.
There are several requirements that help to achieve the goal:
- secure login with username and password
- access levels (customizable) appropriate for each user
- time-stamped audit trails to independently record all actions
- electronic signatures
All requirements of 21CFRpart 11 are met with the WinGPC UniChrom Compliance Pack.