CQV Services: Commissioning, Qualification and Validation
IncepBio's CQV consultants deliver pharmaceutical CQV services and CQV support services for pharma, biotech and life sciences facilities in India, Malaysia and Singapore, from URS and design review to DQ, IQ, OQ, PQ and handover. One CQV engineering partner for Greenfield and Brownfield projects, with audit-ready documents your QA team can approve.
- 10+ years CQV expertise
- ISO 9001:2015 and ISO 45001:2018
- India, Malaysia and Singapore
Where Pharma Facilities Fail During Audits
Most CQV failures are not technical. They are documentation and process gaps that surface when the auditor arrives.
Trained resource unavailability
Trained, deployable CQV teams: engineers with hands-on facility experience, on site when you need them
Technical capability gaps
End-to-end multi-domain expertise across HVAC, BMS, automation and CSV, from concept to handover
Brownfield upgrade and compliance
Brownfield qualification with change control, legacy document review and gap qualification
Incomplete IQ/OQ/PQ and audit readiness
Audit-ready documentation with full traceability across URS, DQ, IQ and PQ for a clean handover
Facing any of these CQV gaps?
Our CQV team can assess your facility, verify critical systems and close the gaps before inspection.
Pharmaceutical CQV and Validation Services
Commissioning, qualification and validation services for every project phase, from validation engineering to process validation, delivered by one CQV team.
Engineering and Design
- CQV engineering and validation engineering services
- URS and design review (DQ)
Commissioning
- Commissioning services (FAT and SAT)
Qualification
- Pharmaceutical equipment qualification
- Pharmaceutical facility and cleanroom qualification
- Pharmaceutical utility qualification
Validation and Compliance
- Process validation services
- Computer system validation
- Requalification and audit readiness
Aligned with US FDA 21 CFR Part 11, EU GMP Annex 1 and 15, WHO GMP, CDSCO Schedule M, ISPE GAMP 5 and ASTM E2500.
Pharmaceutical Systems and Equipment We Qualify
Pharmaceutical equipment qualification, facility qualification, cleanroom qualification and utility qualification under one structured CQV program.
Cleanrooms and HVAC
- Cleanrooms and controlled areas
- HVAC systems
- BMS
- Biosafety cabinets
Process Equipment
- Bioreactors and fermenters
- Autoclaves and SIP systems
- Lyophilisers
- Depyrogenation tunnels
Storage and Thermal
- Cold rooms and freezers
- Stability chambers
- Warehouses
Utilities, Lab and Automation
- Compressed air and gas systems
- Laboratory equipment
- Automation systems
- GxP computerised systems
Commissioning and Qualification of Pharmaceutical Facilities
For Greenfield builds and Brownfield upgrades, we embed trained CQV engineers at your site, from protocol preparation through execution, deviation closure and final documentation.
- 1
Concept and URS
We align on facility requirements and set a QbD, risk-based validation strategy.
- 2
Design Qualification
We verify the design meets the URS and cGMP before procurement.
- 3
FAT and SAT
Factory and site acceptance tests confirm equipment works as intended.
- 4
IQ, OQ, PQ
On-site execution verifying installation, operation and performance.
- 5
Handover
Audit-ready documents, deviation closure and the final traceability matrix.
Typical CQV timeline
A realistic timeframe for qualifying critical equipment and systems. Timelines depend on project size and the number of systems in scope.
GMP Qualification and Validation Deliverables
Every GMP qualification and validation project ends with an audit-ready document package your QA team can approve.
Validation Master Plan (VMP)
Defines scope, strategy, risk assessment approach and responsibilities for the CQV program.
URS Support
Clear, testable user requirements from project start.
Design Qualification (DQ)
Documented proof the design meets the URS and GMP guidelines.
Risk Assessment (FMEA)
Identifies critical parameters and justifies the validation test scope.
FAT and SAT Reports
Executed acceptance tests before on-site qualification begins.
IQ / OQ / PQ Protocols
Pre-approved test plans with scientifically justified acceptance criteria.
Traceability Matrix
Links each URS requirement to its DQ, IQ, OQ and PQ test cases.
Summary Reports
Executed protocols, deviations, CAPAs and confirmation of the validated state.
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Flexible CQV Consulting Services
Choose how you work with our pharma CQV consultants, based on your project size and timeline.
Turnkey Fixed Scope
Turnkey execution of a fixed CQV scope, tailored to your project timeline.
Milestone-Based Delivery
Milestone-based delivery tailored to your project timeline.
Dedicated CQV Resources
Dedicated monthly validation engineering resources deployed to your site.
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Need help choosing the right CQV scope?
Share your project details and our CQV team will suggest the right scope and model.
Why Choose IncepBio as Your CQV Engineering Company
Life sciences domain knowledge with regulatory-driven execution, from commissioning to handover.
On-Site CQV Teams
Our engineers work at your site until the project is complete, in India, Malaysia and Singapore.
Own Calibrated Instruments
Qualification tests run on IncepBio's own instrument fleet, not rented equipment.
IncepOne Tracking
IncepOne, our digital validation software built for HVAC and CQV workflows, keeps documents and progress paperless.
ISO-Certified Quality
ISO 9001:2015 and ISO 45001:2018 certified processes behind every project.
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After handover, keep systems qualified with ValBio requalification support, and see our instrument fleet and IncepOne.
CQV for Pharmaceutical and Life Sciences Companies
CQV in pharma, biotechnology and life sciences, across a wide range of facility types.
Pharma Manufacturing
API and finished dosage production facilities
Biotechnology
Bioprocessing and cell culture environments
Sterile and Injectables
Aseptic processing, isolators and fill-finish lines to Annex 1
Vaccine Facilities
High-containment and large-scale vaccine operations
OSD and API
Oral solid dosage and API synthesis trains
Medical Devices and CDMO
Device lines, design controls and tech transfers
Don't see your facility type? Talk to our senior CQV consultants about your project.
Commissioning vs Qualification vs Validation
CQV stands for commissioning, qualification and validation. Each step answers a different question before a GMP facility can start production.
Commissioning
Checks that equipment and systems are installed and work as designed. It follows good engineering practice and is not always GMP-regulated.
Qualification
Documented proof that equipment, utilities and facilities are fit for GMP use, through DQ, IQ, OQ and PQ.
Validation
Documented proof that a process or computerised system consistently gives the expected result.
What are DQ, IQ, OQ and PQ?
- DQ
Design Qualification
The design meets the URS and GMP requirements.
- IQ
Installation Qualification
Equipment is installed correctly, as specified.
- OQ
Operational Qualification
Equipment works as intended across its operating ranges.
- PQ
Performance Qualification
Equipment performs consistently under real operating conditions.
Frequently Asked Questions
What QA and engineering teams ask us most about CQV projects.
We can mobilize qualified CQV consultants and validation teams within 7 to 14 days to provide on-site CQV services across India, Singapore, Malaysia, and internationally based on scope and site readiness.
Yes. All protocols (DQ, IQ, OQ, PQ) and summary reports strictly adhere to 21 CFR Part 11, EU Annex 1 & 15, WHO GMP, and ALCOA+ data integrity standards at project handover.
We offer flexible commercial models including turnkey fixed-scope execution, milestone-based delivery, or dedicated monthly validation engineering resource support tailored to your project timeline.
HVAC systems, cleanrooms, process equipment, utilities, automation systems and laboratory equipment can all be qualified under a structured CQV program.
Yes. IncepBio provides CQV support from concept design through commissioning, qualification and project handover for new Greenfield pharmaceutical facilities.
Yes. We support facility expansions, remediation projects and compliance-driven upgrades including change control, legacy documentation review and gap qualification.
Yes. Dedicated CQV engineers and validation professionals can be deployed to your site based on project scope, duration and regulatory requirements.
CQV proves that a facility, its equipment, utilities and processes are fit for GMP manufacturing. It gives regulators documented evidence, traceable to the URS, that products can be made safely and consistently.
Start with a Validation Master Plan and clear URS, then run design qualification, FAT and SAT, and IQ, OQ and PQ, with a risk assessment guiding the scope. IncepBio can plan and execute the full programme from concept to handover.
Yes. IncepBio provides global compliance support for CQV projects, with standardized documentation and consistent regulatory compliance.
Planning a new facility or an upgrade?
Get a CQV proposal with scope, timeline and resources for your project.