FDA Focus on Lab Software Compliance: A Critical Matter for Industry

Strategic Insights -

As a former FDA inspector warns, pharmaceutical and biotechnology companies must be vigilant in ensuring the compliance of their lab computer software, as any lapses can result in severe consequences, including product recalls and complaints. A lack of understanding of validation and documentation protocols can leave firms vulnerable to FDA scrutiny, highlighting the need for clear and unambiguous specifications.

Key Takeaways:

  • FDA inspectors prioritize software associated with recalls, complaints, and products that can cause harm to humans, as seen in the case of pacemakers and tongue depressors.
  • Only 2 out of hundreds of audited firms demonstrated a clear understanding of validation and documentation protocols, according to Sean Hilscher, compliance consultant.
  • Ambiguous specifications can lead to issues, as exemplified by the U.S. Army's clear and specific requirements for a flying machine in 1914.
  • Software validation is essential in the development lifecycle to ensure a quality product, with 83% of software project failures attributed to poor requirements (Marc Cromer, Analex Corp.).
  • FDA concerns about software validation highlight the critical importance of proper documentation and verification.
  • Pharmaceutical and biotechnology companies must prioritize compliance and transparency in their lab software to avoid FDA inspections and secure the reliability of their products.

Statistics:

  • 83% of software project failures are caused by poor requirements (Marc Cromer, Analex Corp.).
  • 2 out of hundreds of audited firms demonstrated a clear understanding of validation and documentation protocols (Sean Hilscher, compliance consultant).
  • The U.S. Army specified clear and unambiguous requirements for a flying machine in 1914, including delivering a machine capable of lifting two men weighing at least 300 pounds for 10 miles at an altitude of at least 1,000 feet.

Sources:

  • KMI/Parexel, a compliance consulting firm led by expert Sean Hilscher, Media, PA.
  • Analex Corp., a technical product manager company, Denver, represented by Marc Cromer.
  • The U.S. Army's 1914 specification for a flying machine.