The claim that a company’s paper documentation of GxP activities is their only official records is pervasive and continues to be entrenched in the pharmaceutical and biotech industries.  In fact, the practice rears its head frequently during audits of GMP laboratories and manufacturing sites.  The myth is intimately tied to the belief that a company’s electronic systems are a black box that should not be opened. 

The U.S. FDA and World Health Organization (see references below) require companies to follow good documentation practices for paper and electronic data.  Documentation meeting data integrity requirements must be (1) Attributable to the person who generated the data, (2) Legible, (3) Contemporaneously recorded, (4) Original and (5) Accurate – collectively defined as ALCOA. These essential characteristics apply equally for both paper and electronic records.

Case Study – A pharmaceutical manufacturer received multiple FDA 483 observations for the following:

• “Processed by date/time” on printed chromatograms did not match the “Processed by date/time” on electronic chromatograms
• Numerical testing results on printed chromatograms did not match the numerical data on electronic data files

The FDA re-inspected the manufacturer two additional times and found that the problems were not resolved.  The FDA issued the company a Warning Letter requiring the company to respond in writing within 15 days describing the actions the company would take to correct the problems and the timeline to complete those actions.  

Discover how Eastlake Quality Consulting can improve your systems for review and approval of GMP data.