The Challenge Faced
- Need for QMS alignment across multiple corporate sites
- Segregated processes and procedures at individual manufacturing sites
- Lack of corporate qualification and validation program
- Insufficient training and change control processes
PharmAllies’ Deliverables
- Developed and implemented corporate QMS program
- Quality Manual
- Corporate Policies applicable at all sites
- Developed and implemented local policies and procedures for each of the sites
- Implemented a qualification and validation program
- Validated all equipment and processes
- Implemented the QMS training program
Assessment
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.
