The true test of the success of Automation, MES & Lab software is when it arrives on site. Ensuring the commissioning, qualification and validation (CQV) process runs smoothly is critical to project success and it is a journey that starts early in the project lifecycle with the CSV plan.
Our commissioning, qualification and validation service includes:
- Vigorous testing, validation and quality assurance
- Facility start up and hyper care activities for single or multiple resources with a defined skill set delivering a loosely defined scope over varying contract time periods
- Computer Systems Validation (CSV) programme delivery
- Commissioning, Qualification and Validation (CQV) team support
- Development of risk based approaches to testing
The scope of services we can provide in this regard are outlined below:
| CSV Approach applies the concepts outlined in: | CSV Approach & Planning | CSV Testing & Software Teams |
|---|---|---|
| FDA Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach.
ASTM E2500 – 13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment International Council for Harmonisation (ICH)* Framework ISPE – GAMP 5 Guide: Compliant GxP
|
Integrating your CSV plan with your equipment validation approach Reduced Testing – Time of testing and repeated tests ‘Know your process’ – Risk based testing approach defined by the critical quality attributes and parameters Leveraging the testing into Sustaining Operations – ICHQ10 Quality Systems |
Provision of Factory Acceptance Testing (FAT) teams
Provision of site CSV teams with managed oversight and reporting Provision of Automation, MES and QC Lab IT resources to support CQV Execution of the full risk management lifecycle including the execution of the risk assessments driving actions |
| Project Life Cycle Management Solutions |
|---|
Consultancy Full Proficiency Planning Model to ensuring project success. Read More... |
Enterprise / System Integration World leading Automation, Process Control and MES project implementation. Read More... |
Services Managing and optimising your investment for long term success. Read More... |
Learning & Capability Solutions Your global Life Science Training Partner. Read More... |
