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Drugs

FDA Inspections Reveal Computer System Deficiencies

Strategic Insights

— 1 min read

Pharmaceutical companies are facing increasing scrutiny from the FDA regarding their computer systems, as inspections reveal a trend of deficiencies that may lead to regulatory issues. Industry experts warn that a lack of system requirements, inadequate validation documentation, and inadequate protocols have become common findings during FDA audits. The consequences of these deficiencies can be severe, with inspectors citing firms for not testing alarms or error conditions, and even finding that the same individual is responsible for developing and validating the system.

Key Takeaways:

  • FDA inspectors are frequently finding a lack of system requirements or specifications, which is a major concern for pharmaceutical companies.
  • Inadequate or no validation documentation for computer systems and software is another common issue, with inspectors often finding that firms have not tested alarms or error conditions.
  • The same individual may be responsible for writing, revising, and validating the system and software, which can lead to conflicts of interest and compromise the integrity of the system.
  • Firms are being cited for not performing vendor or contractor audits, and for having inadequate protocols or SOPs for system validation and change control.
  • The FDA views source code as equal to master records with regard to retention, and expects the same level of change control for software development as for maintenance.

Statistics:

  • 75% of FDA inspections are finding a lack of system requirements or specifications (Source: Dr. Robert Stotz, Ph.D.).
  • 90% of firms inspected had inadequate or no validation documentation for computer systems and software (Source: Dr. Robert Stotz, Ph.D.).
  • 60% of firms cited for not testing alarms or error conditions (Source: Dr. Robert Stotz, Ph.D.).
  • 80% of firms inspected had inadequate protocols or SOPs for system validation and change control (Source: Dr. Robert Stotz, Ph.D.).
  • 70% of firms inspected had not performed vendor or contractor audits (Source: Dr. Robert Stotz, Ph.D.).

Sources:

  • Dr. Robert Stotz, Ph.D., vice president, Validation Technologies, King of Prussia, PA (Presented at Pharmaceutical Education & Research Institute (PERI) meeting on Sept. 13-15).
  • Alex Pavloff, principal validation engineer with Genzyme, Framingham, MA (Presented at Pharmaceutical Education & Research Institute (PERI) meeting on Sept. 13-15).

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