Be More Accurate. Get More Done.
Commissioning, Qualification, and Validation (CQV)
- Scope, timelines, and budgets are actively managed to meet your requirements.
- Safety is always the first priority and all commissioning is supervised by appropriately qualified personnel.
- Our expertise in factory-based qualifications support compressed start-up schedules.
- Extensive design and process experience facilitates required technical understanding.
- A single-point of contact Technical Project Manager is assigned to your project with oversight from our Project Management Office (PMO).
- ISPE’s GAMP V-model is fully leveraged and all validations are based on approved, testable requirements.
Your Regulatory Requirements
Kymanox knows how to comply with the regulations issued by governmental agencies (e.g., FDA, EMA, Health Canada) and how to make the most of industry guidance issued by both governmental and non-governmental bodies (e.g., ISPE, ISO, ICH, WHO):
- Kymanox knows what regulations apply to you and how to implement a phase-appropriate and risk-based approach.
- Kymanox understands how to interpret the regulations and available guidance.
- Experienced in biotechnology, pharmaceuticals, medical devices, and combination products.
Kymanox knows that documentation is everything and is as important as the quality of executed work. Our documents stand as monuments and can be leveraged for the business. Documents we prepare and execute include:
- Validation Project Plans (VPPs), Validation Master Plans (VMPs), and Criticality and Risk Assessments
- User Requirements (URS), Functional Requirements (FRS), Detailed Design Specifications (DDS)
- Policies, Standard Operating Procedures (SOPs), Forms, Work Instructions and Master Batch Records
- Factory and Site Acceptance Testing (FAT/SAT)
- Turnover Packages (TOPs), Design Reviews, and Trace Matrices
- Commissioning Protocols, Validation Protocols (DQ/IQ/OQ/PQ), and Final Reports