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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.
Unpacking the Regulations: Understand 21 CFR 1271
21 CFR 1271 is a regulation set forth by the US Department of Health and Human Services (HHS) that addresses the manufacturing, processing, and labeli
Unveiling the Mysteries of 21 CFR Part 820 & ISO 13485
The 21 CFR Part 820 is a quality system regulation (QSR) issued by the United States Food and Drug Administration (FDA) which governs the design, manu
21 CFR Part 11: Open vs Closed Systems – What’s the Difference?
The 21st Century Cures Act (21 CFR Part 11) is a US Food and Drug Administration (FDA) regulation on the security and integrity of electronic records
Unraveling Regulations: 21 CFR Part 11 vs EU Annex 11
In today's digital age, organizations must be equipped to manage electronic records in a consistent, secure manner. In order to achieve this obj
Compliance with HITRUST: What It Is and Why It Matters
HITRUST certification is a highly-regarded IT security and compliance certification program. HITRUST stands for Health Information Trust Alliance, and
Unlocking Healthtech Success:Understanding Business Models
When it comes to the world of healthcare, technology is becoming increasingly essential for medical organizations to increase patient satisfaction, re
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