As technology increases, so does risk for non-intended use and ultimately non-compliance.
Regulatory focus is primarily on raw data, data integrity, and SOPs (i.e., procedures not compromising the inteded use and, ultimately, the raw data).
The integrity of the electronic record must be assured if raw data are to be maintained in electronic format. About the Author Henrik Johanning is CEO and senior partner, Genau & More; John Lee is executive director, Pharma Net Inc., former FDA Investigator; Christian Hemming is QA Manager, QAtor A/S; Lise Christensen is QA Director, CMC Biologics A/S.At Minitab, we conduct extensive internal testing to maintain the highest quality of our software products.We employ rigorous testing methods such as automated regression tests, manual calculations, and comparison with other notable benchmarks to validate proper functionality of the software and numerical accuracy of results.FDA issued warning letters in 2012 due to lack of documentation of intended use. Fortunately, top management, quality executives, and engineers are becoming more aware of potential regulatory pitfalls and breaches as the industry becomes familiar with computer systems and generated data. FDA, 21 CFR 11, Electronic Records; Electronic Signatures 2.
In contrast, several risk-averse pharmaceutical companies choose to validate, in-depth, vendor-supplied pre-validated “standard” software.