The Cubis® II balance, with pharma package, contains all the technical controls to support compliance with common regulations.
Discover FDA 21 CFR Part 211 (CGMP) impact on pharmaceutical... Read more Annex 11: A comprehensive compliance checklist Dive into the nitty-gritty of Annex 11. Learn about the requirements... Mastering risk assessment for life sciences organizations ...
21 CFR Part 11 simplifies records management and signature processes by permitting the use of digital technology for these quality tasks. FDA-regulated companies will naturally benefit from more speed and better efficiency, which can be achieved with the rightquality management system (QMS). ...
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations established by the United States Food and Drug Administration (FDA) as regulation on electronic records and electronic signatures (ERES). Part 11 defines the criteria under which electronic signatures and electronic ...
Need a document management and signing solution that is compliant to the FDA’s 21 CFR Part 11? In this blog, we’ll discuss how GMO Sign is compliant to the FDA’s 21 CFR Part 11.
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall com...
21CFR Part 11electronic signatureselectronic recordsA 21 CFR Part 11 Checklist can satisfy many business, process, and educational needs of companies that use computer systems that must comply with Part 11. This article identifies a strategy for creating your own Part 11 Checklist. Suggestions are ...
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Arbour Group's extensively trained professionals evaluate a client's use and documentation of electronic records and electronic signatures as governed by applicable regulatory requirements. The result of a 21 CFR Part 11 compliance checklist and assessment determines the effectiveness of a client's proces...
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