- BioPharm International-05-01-2003
- Volume 16
- Issue 5
Part 11 Is Not Going Away: The New Electronic Records Draft Guidance
by Wolfgang Winter, Agilent Technologies GmbH and Ludwig Huber, Agilent Technologies GmbH The rules for electronic records and signatures still remain in effect. The change means that companies must now justify their decisions on whether or not to implement specific electronic controls with documented risk assessments and considerations of the record requirements detailed in the corresponding predicate rule.
Articles in this issue
over 22 years ago
Sumeria to Satellites: Evolution of the Bioreactorover 22 years ago
Patent Law: Extracting Maximum Value from Your Patent Portfolioover 22 years ago
Inside Washington: Medication Safety in the Limelightover 22 years ago
Survival Strategies: The Life Sciences Industry Turns to eLearningNewsletter
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