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Associate Partner LaToya Lee Shares Perspectives on the Importance of Software Validation

Clarkston Consulting’s LaToya Lee was recently featured by Outsourced Pharma, and others (Pharmaceutical Online, BioProcess Online, BioSimilar Development, and Cell and Gene) for details on Form 483 and and the importance of proper software validation. Read a few excerpts from the piece below or the full article here.

August 17, 2022 | Durham, NC

How To Avoid Form 483s For Biopharma Software Validation Failures

The FDA issues a Form 483 if an inspector from its Office of Regulatory Affairs (ORA) encounters objectionable deficiencies during inspection. The form serves to communicate any observed violations of regulatory compliance standards. As of July 2022, approximately 100 FDA warning letters have been issued to pharmaceutical and biotechnology companies.  The Inspectional Observation Summaries2 released by the FDA reveal that most of the noncompliance in the GxP environment is due to:

  • data integrity failures
  • inadequate and/or unimplemented written procedures
  • deficiencies in investigations
  • substandard laboratory controls

A Form 483 issuance can be a significant disruption to your company. Proper software validation – although a significant investment – will bring immense value to your organization. Software validation is not only critical for compliance but also for business growth and overall success. Proper software validation can help protect revenue streams, encourage organizational collaboration, and enable scaling up your operations. Investing in and properly validating software can help you realize your business’ short- and long-term goals and help prevent Form 483 violations.

Read the Full Outsourced Pharma Article Here