Paper vs Electronic Records

This week, Stacey is joined once again by Chris Wubbolt. Stacey and Chris discuss the ins and outs of paper vs. electronic records. In GMP-regulated environments maintaining proper records and documentation is critical to data integrity, regulatory compliance, and GMP best practices. Starting with Part 11 more than two decades ago, we’ve seen an emphasis on good record keeping and a shift to paperless. Still, paper-based systems are prevalent around the world, but given our current environment and reliance on digital technologies are we now at a point where the industry is ready to embrace that shift?
About our guest:
Chris Wubbolt
Chris has over 25 years of experience in the regulated industry and has provided compliance, quality assurance, and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
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Thank you Stacy