Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
Manufacturing systems should be designed using the principles of good documentation practice to ensure data integrity. Industry experts describe issues with validating, using, and auditing paper and electronic records. Records must meet the core principles of ALCOA+ (data must be attributable, legible, contemporaneous, original, accurate, complete, consistent, and enduring).
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Thermo Fisher Opens Advanced Therapies Collaboration Center in California
April 18th 2025The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.