Our validation specialists are trained in current Good Manufacturing Practices (cGMP) and have experience implementing them in the Pharmaceutical, Biotech, Food & Beverage, Consumer Products and Chemical Industries. Integrating commissioning and validation with design engineering and scheduling allows our validation specialists to have input from conceptual design through commissioning, resulting in the design and construction of a validatable facility or system.
Sierra works directly with our clients’ engineering, operations, and quality personnel to provide commissioning and qualification (C&Q) documentation that meets their needs for compliance with federal regulations.
Our validation specialists provide turnkey commissioning and qualification services including commissioning and qualification C&Q project management and coordination as well as document development and execution from the commissioning & validation master planning phase through validation summary reports.
We have successfully commissioned and qualified GxP API Plant, Hydrogenator, Drier, Centrifuge, Manufacturing and packaging equipment, Utility systems, HVAC systems, Production suites, Packaging suites and Warehouses.
- Validation Master Plans (VMP)
- Conceptual, Definition, & Master planning services
- Control system studies, site audits, & evaluation
- Process control strategies
- P&ID/PFD development
- Design Qualifications (DQ)
- GAMP Specifications (URS/FS/DS)
- Detailed control system design & engineering
- Electrical & I/O wiring diagrams
- Instrument specification & installation details
- 21 CFR Part 11 Compliance
- Control panel design
- Factory & Site Acceptance Tests
- Construction Management
- Commissioning & field startup
- Installation Tender
- Shutdown and startup philosophy
- Qualification Protocols (IQ/OQ/PQ/CV)
- Commissioning Plans (CP)