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
Category
Security & Compliance
Insights and guides filed under Security & Compliance.
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
Discover What Healthcare Compliance Means & How to Implement It
Healthcare compliance is the practice of making sure that organizations follow all laws, regulations, and policies related to the healthcare industry.
Master the Basics: Unlocking the Power of eMandates
An eMandate is an electronic authorization for direct debit payments. The system is designed to streamline the payment process, reducing administrativ
Unlock HIPAA Compliance: The Complete Guide
The Health Insurance Portability and Accountability Act (HIPAA) is a standard which all healthcare providers, organizations, and insurance companies m
