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Abbott Laboratories is retaining an outside consultant to audit its manufacturing and quality assurance systems at its diagnostics division following a request in a March 13 FDA warning letter, Abbott told GMP.
It is often said the pharma industry has lagged behind others in converting from paper-based recordkeeping, notably in clinical trials, to an all-electronic environment.
Skilled vendors can do a lot for an FDA-regulated life sciences firm -- but if there are problems with their work, the agency will place the burden of responsibility on you and make it tough to shake, an industry expert said.
Urgency surrounding Part 11 and electronic record security controls has ebbed and flowed for many years as the FDA’s own emphasis has appeared to wax and wane, but one constant remains: Audit trails are critically important when dealing with FDA inspectors, experts tell PIR.
Research organizations may think their data is secure, but if even one employee is burning CDs or printing information and taking it home, then there is a problem, an expert warns.