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Digitizing Processes to Align with GMP Requirements
In 2019, the failure to document quality responsibilities and procedures was the top citation in the Form 483 reports issued by FDA. The next most common inspection finding citation related to compliance with good manufacturing practices (GMP), moving up from its third-place position in 2018, was failure to thoroughly review unexplained discrepancies or failure of batches to meet specifications (1).
These are all common lapses that start small but lead to major compliance roadblocks for life-sciences companies of all sizes. The reason for their occurrence can be easily explained: manual processes are the biggest threat to compliance with GMP requirements. Making the case that paper is the greatest enemy of GMP compliance and the leading cause of the escalating cost of quality is not difficult.
Read the full article here: Digitizing Processes to Align with GMP Requirements
