Commissioning, Qualification & Validation

DECI provides CQV solutions delivering high quality, compliant executions in line with Industry Regulations and Clients requirements in Life Science industry. In DECI, we understand that CQV isn’t just about the paperwork, but about the quality, safety, reliability and repeatability of our client’s facilities and processes.

Service Offering:

Providing integrated teaming solutions on Commissioning,
Qualification & Validation
Construction Verification & Quality Assurance
CQV Procedure
We will adopt the existing process and procedures that are in use
We can supplement process and procedures if the client deems fit
Protocol Generation and Execution

DECI C&Q team will integrate with the existing organization

C&Q team will be introduced at Basis of Design Stage.
Develop the Commissioning Master Plan and the Validation Project Plan.
Liaise Proactively with relevant Stakeholders. (Client & Project)
Set System Boundaries in line with project schedule/phases.
Perform Design Reviews/ Design Qualifications.
Oversee and Perform Risk Assessments.
Review Construction Turn Over Pack contents for Completeness.
Perform ‘As Built’ Walk Downs and Witness Critical Testing.

Commissioning & Qualification

Generate, Review and bring to Approval C&Q Protocols and Reports through the project lifecycle.
Manage and Track Deviations/punch lists to closure.
Manage and Protect the Qualification process by monitoring Change Controls.
Track User Requirements Specifications through to Testing.
Ensure Schedule, Budget and Quality Compliance, following GEP, cGMP, GLP, GDP principles.
Perform Lessons Learned on the project to future protect our Client’s new projects into the future.

Validation Methodology

DECI’s C&Q team are experienced in the following Qualification methodologies applied in the life Science Industry:

In addition DECI’s C&Q team are practiced in leveraging from Commissioning into Qualification.

DECI’s C&Q team are up to date on current industry standards and will work with the Client to deliver high quality, compliant executions in line with Industry Regulations and Clients requirements.