GxP Lifeline
"In a Data-Driven Ecosystem, Don't Let Data Integrity Be Your Achilles' Heel"
Data integrity ensures the quality of your product, and yet it’s not always a top priority for some organizations. Without it, you can’t meet regulatory requirements or get to market. Now is the time to focus on data integrity by:
- making it part of your risk-management plan
- controlling system access
- retaining raw data
- having a clear audit trail
- validating your system
- allowing data to be invalidated
- capturing electronic signatures correctly
Identify any gaps in the product life cycle and improve data integrity. Read the full article written by Coda Corp USA.
Gina Guido-Redden is a quality and regulatory professional with over 25 years of domestic and international industry experience. She is the co-founder and chief operations officer of Coda Corp USA, which provides consultancy services to pharmaceutical, biologics and medical device firms.
Guido-Redden’s history specializes in the areas of facility start up, regulatory compliance and remediation, quality system development, mentorship and training, quality system design, and implementation and management.
She is also a quality systems subject matter expert (SME), frequent seminar presenter, and content contributor to industry publications, including GAMP’s White Paper on Part 11, The Journal of Validation Technology, New Generation Pharmaceuticals, Computer Validation Digest, and MasterControl’s GxP Lifeline. Coda Corp USA is an enterprise partner of MasterControl.
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