LifeSpec delivers end-to-end Commissioning, Qualification, and Validation services for pharmaceutical and bioscience companies operating under cGMP guidelines.
Who We Are
LifeSpec is a specialized CQV consultancy focused on helping pharmaceutical and bioscience companies meet regulatory requirements with rigorous, audit-ready documentation. We embed with your teams to build validation programs that hold up — from FAT through process validation.
Our consultants bring deep cGMP knowledge across drug manufacturing, biologics, and medical devices, ensuring your validation lifecycle is both technically sound and inspection-ready.
Oral solids, sterile injectables, APIs, and packaging lines.
Cell therapy, mAbs, gene therapy, and bioprocessing equipment.
21 CFR Part 11, Annex 11, USP <1058>, and ICH Q10 aligned.
21 CFR Part 11 & Annex 11 compliant CSV for MES, LIMS, SCADA, and DCS systems.
What We Do
From initial commissioning through continued process verification, we support every phase of your validation lifecycle.
Factory and site acceptance testing, P&ID walkdowns, design qualification, and system turnover to ensure your equipment is installed and operational before qualification begins.
Protocol authoring, execution, and summary reporting for equipment and systems. Risk-based approaches aligned with ASTM E2500 and ISPE GAMP 5 frameworks.
End-to-end CSV for manufacturing execution systems, LIMS, DCS, SCADA, historians, and laboratory instruments — fully aligned with 21 CFR Part 11 and Annex 11. We author validation plans, IQ/OQ/PQ test scripts, traceability matrices, and summary reports that satisfy both FDA and EMA expectations.
Site and project-level VMPs that define scope, strategy, responsibilities, and documentation requirements across the full validation lifecycle.
Documentation
Every document we produce is written to withstand FDA, EMA, and third-party auditor scrutiny — traceable, complete, and aligned with current industry standards.
We work with regulated manufacturers across the pharmaceutical and bioscience spectrum, from startups scaling their first GMP facility to established manufacturers managing complex multi-site programs.
How We Work
A structured, transparent approach from first conversation to final report.
We assess your facility, equipment, regulatory context, and project timeline to define a tailored CQV scope.
We author the VMP and qualification strategy, including risk assessments and a document matrix.
Protocol authoring, on-site or remote execution, deviation management, and real-time documentation.
Summary reports, punch list resolution, and a complete, inspection-ready documentation package.
Get in Touch
Whether you're commissioning a new facility, qualifying a piece of equipment, or need documentation support — we're ready to help. Reach out for a free initial consultation.