The Challenge Faced
- Decommissioning of pharmaceutical manufacturing, packaging, utilities/facility, and lab operations
- Decommissioning of 2,725+ GMP systems
- Minimized impact to GMP production throughout the decommissioning process
- Reconciled data and batch records
- Completed GMP document storage
- Overall site decommissioning strategy development and implementation
- Creation and implementation of the decommissioning training module
- 1,136 lab systems decommissioned
- The shutdown of all GMP systems and assets
- 3,129 end-calibrations completed
- Archived over 10,000 GMP documents
- 156 computer system decommissioned
PharmAllies® provides consultation services to the regulated industries, with specializations in project management, operational excellence, and quality compliance. Our professionals have the experience and equipment necessary to provide solutions for your QMS implementation, commissioning, decommissioning, computer system validation, and equipment qualification needs. Our business model relies on project management methodology and Lean Six Sigma tools, coupled with a risk-based engineering approach to deliver successful project implementation.
PharmAllies is committed to keeping a continuous focus on the regulatory environment to provide reliable results for our clients. Our capability in the Life Sciences has helped our clients streamline efficiency, increase productivity, and create risk-based compliant systems.