Interesting situation today. I audited a software development CRO managing the stability testing data for a pharma organization. Some of you may or may not know the importance of stability testing for drug approval. I have performed many audits for this particular pharma organization and Im finding time and time again a real deficiency exists with the CROs that they are hiring. These deficiencies seem to be fundamental areas of procedural and process structure. Areas of quality management like document control, structured SDLC, risk management, etc.
Now my background is working primarily with compliance for device manufacturers, so maybe my expectations are too high but this company seems to have a substandard set of quality controls especially around SW development.
Has anyone encountered this trend of gross negligence in quality. Are my expectations too high?
Thoughts and comments appreciated.
Regards,
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Thomas Bento
RABQSA Lead Auditor #108990
11665 Avena Place, Suite 203
San Diego, Ca. 92128
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