FDA Change Management

In the pharmaceutical industry, change management is one of the key elements that makes up a pharmaceutical quality system. It is becoming increasingly difficult for companies to manage the significant peaks of activity that occur with change management related to capital projects, facility and equipment maintenance, process improvements, and general regulatory requirements. Our highly trained staff of engineers enables clients to effectively augment internal teams with people who understand the equipment and processes to truly manage and execute on your behalf. Our proven success drives quick and reliable delivery of essential change management requirements mandated by the FDA.

An effective change management system should include:

  • Quality risk management to evaluate proposed changes; the level of effort and formality of the evaluation should be commensurate with the level of risk
  • Proposed changes should be evaluated relative to the marketing authorization, including current product and process understanding and/or design space
  • Expert teams, with appropriate expertise and knowledge, should evaluate proposed changes
  • An evaluation of the change should be undertaken after implementation to confirm the change objectives are achieved
  • A complete documented history of the change, assessment, and implementation must be completed and filed for internal and governing body audits

Change Management

The FDA Change Management services provided by Clarke Solutions include:

  • System and Equipment Validation Periodic Assessments and Remediation
  • Operational and Quality system policy and procedure development
  • CAPA (Corrective and Preventative Action) investigations and implementation
  • Complete change control management within client quality systems to:
    • Open/Close
    • Develop
    • Manage
    • Execute change control and validation activities

For more information regarding Clarke Solutions’ FDA Change Management services, contact us here or call 317.849.0330 today for a free, no-obligation risk assessment.