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Demystifying FDA CFR Part 11: A Guide for Life Science Companies

Demystifying FDA CFR Part 11: A Guide for Life Science Companies

For life science companies, compliance with regulatory standards is paramount to ensure the safety, efficacy, and quality of products and processes. One such critical regulation is FDA CFR Part 11, which governs the use of electronic records and...

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Tags: FDA compliance software, Quality Management System, 21 CFR compliance, Compliance, fda cfr part 11

The Best 21 CFR Part 11 Compliant Software Has These Features

The Best 21 CFR Part 11 Compliant Software Has These Features

If your company is required to adhere to FDA 21 CFR Part 11 compliance, a document management system can make this process simple. However, not every system is built the same, and there are certain features your company should look for in a DMS...

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Tags: 21 CFR compliance, Compliance, Document Compliance Software

2019: Document Management Year in Review

2019: Document Management Year in Review

2019: Document Management Year in Review

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Tags: 21 CFR compliance, managed cloud, year in review

How To Address Electronic Signature Compliance

21-CFR-Part-11-Compliance

Compliance is a top concern for businesses across industries, including healthcare, medical device, laboratories, and more. To stay compliant, organizations need to make sure multiple aspects of their operations are following regulations set forth...

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Tags: FDA Compliant Document Control Software, FDA Electronic Signature, Electronic Signature, Digital signature, 21 CFR compliance