What follows is based on what we observe across validation programs actively navigating AI adoption for computer systems validation documentation.…
We had record registrations for our last webinar, Revolutionizing Validation & Risk Assessments: Introducing Fast and Low-Cost AI-enabled Validation as…
For life sciences organizations, CFR Part 11 is a regulatory requirement for validating authenticity, integrity, and confidentiality of electronic records…
The purpose of this article is to review the solution to four (4) common challenges when using spreadsheets to meet…
Executive Summary The United States Food and Drug Administration’s (FDA) modern regulatory function started with the 1906 Pure Food and…
What is Document Controls? The Document Control process involves the management of documents in terms of creation, review, approval, distribution,…
Guest Author: Heather Longden Ms. Heather Longden has thirty (30) years of experience in regulatory compliance in the pharmaceutical…
Guest Author: Heather Longden Ms. Heather Longden has thirty (30) years of experience in regulatory compliance in the pharmaceutical…
Since the FDA’s Data Integrity guidance came out in April 2016, there has been a lot of interest on the…
Companies that use spreadsheets for business process that involve GCP, GLP or GMP outcomes often look to tighten up good…
