A 180,000-sqft sterile-fill pharmaceutical manufacturer migrated from paper-based PM tracking to Maintoro under formal validation protocol — and produced their first FDA PAI in 22 years with zero maintenance-related 483 observations.
Paper PM logs failed cGMP scrutiny routinely; calibration cycles drifted from manufacturer specifications; deviation investigations took 6–8 weeks to close because retrospective batch-impact analysis was a manual paper exercise. The site had received maintenance-related 483 observations on every FDA inspection in its 22-year history.
A 16-week validated deployment under formal change control:
PM compliance tracked daily across all manufacturing-relevant assets. FDA PAI inspection results compared against site's 22-year history of inspection outcomes. Calibration deviation investigation duration measured from initial out-of-tolerance reading to Quality release of investigation report.
“We held 99.4% PM compliance for 4 quarters and our last FDA PAI closed with zero maintenance-related 483 observations — first time in the site's 22-year history. The Part 11 controls held up to inspector scrutiny because they were designed in, not bolted on.”
Electronic signatures, audit trails, and validation packages built into the platform from day one.
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