Specialized CQV & CSV for Highly Regulated Industries
Implify's Life Sciences Consulting practice specializes in Computer Qualification & Validation (CQV) and Computer System Validation (CSV) for pharmaceutical, biotechnology, and medical device companies operating in highly regulated GMP and GLP environments.
Our consultants are trained in the full validation lifecycle — from Installation Qualification through Performance Qualification — and have delivered validation projects for some of the world's leading life sciences organizations, including Bristol Myers Squibb, Pfizer, Eli Lilly, Merck, Moderna, and many others.
What We Deliver
- Computer Qualification & Validation (CQV) — IQ, OQ, PQ protocols for manufacturing and lab equipment
- Computer System Validation (CSV) — 21 CFR Part 11 compliant validation for regulated software systems
- Validation Master Plan (VMP) — site-level validation strategies and regulatory documentation
- Manufacturing System Validation — bioreactors, fermenters, filling lines, lyophilizers
- Laboratory Instrument Validation — HPLC, UV-Vis, GC, LIMS, analytical instruments
- Utility System Validation — HVAC, WFI, Clean Steam, compressed gases, cleanrooms
- DCS/SCADA & MES Validation — process control system qualification
- Audit Readiness & Remediation — FDA, EMA, and ICH compliance support
Regulation & Compliance Expertise
Implify's life sciences consultants are well-versed in FDA 21 CFR Parts 11, 210, and 211; EU Annex 11; ICH Q7, Q8, Q9, and Q10; and GAMP 5. We stay current with evolving regulatory requirements to ensure your validation programs remain inspection-ready at all times.
Validation Lifecycle
Validation Planning
Develop Validation Master Plans, risk assessments, and project timelines aligned to regulatory requirements.
Risk Assessment
Conduct FMEA-based risk assessments to define validation scope, critical parameters, and acceptance criteria.
Protocol Development
Author IQ, OQ, PQ, and CSV protocols to GMP standards with complete traceability to URS and functional specs.
Execution & Testing
Execute validation protocols on-site or remotely, documenting all test results in accordance with data integrity requirements.
Reporting & Closure
Author validation summary reports, manage deviations and CAPAs, and formally close validation projects.
Trusted by Leading Life Sciences Organizations
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