Compliance-ready documents, explained
Practical guides on 21 CFR Part 11, electronic signatures, audits and digital SOPs for pharma and life sciences teams.
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Guides from the MSB Docs compliance team.
How to Handle FDA Audits for Electronic Records Compliance
FDA audits are a crucial aspect of regulatory oversight for businesses handling electronic records, particularly those using Electronic Signature Cont
21 CFR Part 11 Compliance: Key Elements of a Validation Plan for 21 CFR Part 11 Systems
Ensuring compliance with 21 CFR Part 11 is a critical step for organizations in the pharmaceutical industry and other regulated sectors.
Pharma: Steps to Conduct a Self-Assessment for 21 CFR Part 11 Readiness
In the pharma industry, compliance with 21 CFR Part 11 is not optional—it’s a necessity. This regulation, established by the FDA, ensures that ele
Electronic Signature Contracts: Secure Storage & Retrieval
With businesses increasingly relying on Electronic Signature Contracts, securely storing and retrieving eSigned documents has become more important th
Pharma: Multi-Factor Authentication for 21 CFR Part 11 Compliance
Pharma companies operate in a highly regulated environment where data security and compliance are paramount. Ensuring compliance with 21 CFR Part 11 i
Electronic Signature Contracts: What FDA Requires
The shift from traditional wet signatures to electronic signatures (eSignatures) has transformed how businesses and regulated industries manage contra
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