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Top 10 Cloud Vendor Audit Failures

  1. SDLC & implementing quality engineering practices exist only in informal work practices; not documented in formal procedures
  2. No formal definition of SDLC phases, deliverables by phase, phase gate reviews, etc
  3. Lack of defined coding standards
  4. Process for code reviews, frequency of reviews, criteria used and method of documenting code reviews not adequately defined
  5. Backup process utilizes automated tools/utilities and lacks regular review of backup logs to identify failed backups or skipped files. No investigation or escalation of failed backups
  6. No regular testing of restoration process to ensure that files can be restored from backup, if and when, needed
  7. Utilities/tools used for bug tracking do not include objective evidence/traceability of test history including initial test failure, to bug ID, to fix/remediation, to retest case and final test results
  8. Test cases do not include recording of actual results and evidence of comparison with expected results for pass/fail determination
  9. Lack of defined preventive maintenance program for critical data center utilities including fire detection/suppression, HVAC system and emergency diesel generators
  10. Lack of annual review, update and simulation exercises/testing of Disaster Recovery/Business Continuity Plan

 

About the Author:
Robert (Bob) Lesnefsky is the Global Vice President of Quality Assurance and Regulatory Compliance and Auditing at USDM Life Sciences. He is a seasoned quality assurance and regulatory compliance professional with 30+ years of experience in quality assurance and regulatory compliance in the pharmaceutical, biotechnology, medical device, nuclear and petrochemical industries. Bob is sought out as the GMP/DEA compliance expert in providing compliance opinions and interpretations of cGMP to manufacturing, operations, quality and client services to ensure compliant drug product manufacturing operations.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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