Articles Tagged with ''Part 11''

EDMS Validation Depends on Risk Posed by System

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.

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Understanding Aspects of System Is Key to Using 'Predicate Rules'

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.

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GAMP Releases Electronic Records and Signatures Guide

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."

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GAMP to Release eRecords Guide Next Month

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.

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COALITION CASE TO KILL PART 11 HAS HOLES, EXPERTS SAY

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.

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INDUSTRY COMMENTS APPLAUD PART 11 REVISION

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.

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