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Tools to Transform

IPT: How has compliance changed in the last decade? Andrew Smith: Manufacturers are experiencing tough scrutiny across the globe, and the spectrum of their industries, especially in quality control activities, safety reporting, and manufacturing operations. Organisations have, therefore, started paying more attention to reduce risks through the implementation of strong management controls.

Electronic batch records (EBR) were once mainly used for helping pharmaceutical companies automate away the mountains of paperwork required for maintaining production batch records.

When part of the FDA specification known as title 21 of the Code of Federal Regulations part 11 was issued, production facilities were permitted to use EBRs to document each step in the production, packaging, and handling of every batch of their products. Since then, industries began to realise how automating batch records can also help them improve workflows and efficiencies.

Andrew Smith at Rockwell Automation (October 2021)

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