Life sciences computer systems regulatory can be overwhelming. We can help you cut to the chase and get your electronic record keeping system validated in accordance with 21 CFR Part 11. We have worked with company's to review documentation and make suggestions on how they can be more compliant. We can help you setup a validation effort that tracks the testing process and coordinates the resources. We can help with IQ, OQ, and PQ development, setup and audit your IT SOPs (standard operating procedures) and guidelines. We work with partners like Praxis Life Sciences for larger projects.

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