Simplifying Global Compliance
Articles Tagged with ''Part 11''
To determine whether an electronic document management system (EDMS) requires validation, companies should identify the regulatory and/or business risk the system poses to product safety, efficacy and quality, according to an industry expert. Read More
The key to adhering to a predicate rules-based system for GMP and using a risk-based approach for computer system compliance successfully is to understand how systems are being used as part of the entire process, understanding if and how your company is relying on the system and understanding the impact of the system, according to an industry expert. Read More
The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), has released its "GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures." Read More
The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), will release its “GAMP Good Practice Guide: Risk Management Approach to Electronic Records and Signatures,” on Feb. 18 at an ISPE conference in Tampa, Fla. Read More
Despite cries from some industry groups to kill 21 CFR Part 11, the FDA isn’t likely to take such a drastic step, according to a former FDA policymaker. Read More
Janssen Pharmaceutica has selected ABB to install a Part 11-compliant manufacturing system in its new greenfield active pharmaceutical ingredient (API) plant in Cork, Ireland. Read More
The FDA will make substantial changes to and relax some of the requirements of 21 CFR Part 11, but the controversial rule won’t go away, according to a former FDA policymaker. Read More
Pharmaceutical companies are expected to increase information technology (IT) spending by roughly 5 percent during the next 12 months, with a majority of the investment coming in the clinical trials arena. Read More
While a recent Citizen Petition asking the FDA to revoke 21 CFR Part 11 presents a compelling case, it does not always demonstrate that existing federal regulations are strong enough to protect electronic data and electronic signature integrity without Part 11 in place, said experts at a recent Drug Information Association (DIA) panel. Read More
Pharmaceutical and medical device companies generally agree that the FDA is doing the right thing to reevaluate its Part 11 rule, but most firms believe that the regulation should not be wiped away completely. Read More
Copyright ©2017. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing