Qualification Services for Life Sciences: Achieving Regulatory Readiness & Data Integrity
In the life sciences industry, Qualification is the cornerstone of regulatory compliance and operational integrity. It’s the documented proof that your equipment, systems, and processes are suitable for their intended use and consistently produce results that meet predetermined specifications. Genesis AEC’s Qualification specialists provide comprehensive services that ensure your facility and its critical components are fully validated and audit-ready.
Achieving compliance with stringent regulations in a GxP facility is a complex task. Adopting a risk-based approach is the key to project success and a smooth equipment turnover. With Genesis, you’re ready for manufacturing and quality release operations on day one. Our qualification and validation experts apply their hands-on industry knowledge to guide you through the validation process, taking time to learn “what you do” and “how you do it.”
Our expertise spans the entire qualification lifecycle, from initial planning to execution and final reporting, adhering to global regulatory standards such as FDA’s 21 CFR Part 210, 211, and European GMP guidelines. We offer:
- Installation Qualification (IQ): Verifying that equipment and systems are installed according to specifications.
- Operational Qualification (OQ): Confirming that equipment and systems operate within their specified ranges.
- Performance Qualification (PQ): Demonstrating that equipment and systems consistently perform as intended under actual operating conditions.
- Computer System Validation (CSV): Ensuring software and automated systems meet regulatory requirements for data integrity and reliability.
- Re-qualification & Periodic Review: Maintaining the validated state throughout the operational lifespan.
Computer System Validation (CSV) Capabilities
- 21 CFR Part 11 Compliance
- Software/System Development Life Cycle (SDLC)
- GAMP Compliance
Our validation professionals provide swift issue identification and resolution, and adeptly navigate regulatory hurdles. We’re well-versed in current standards such as FDA, EU, ISO, USP, and ISPE with proficiency in electronic validation and document control systems such as Kneat, eVal, and Trackwise. In short, we’re investigators and problem-solvers. We excel in planning, reviewing, executing, validating, and turning over scientific and process equipment for use in GxP environments.
Our Equipment Expertise
- Laboratory Equipment: Liquid Handler Systems, Density Meters, Plate Readers, Plate Washers/Stackers, Cell Counters, Complex Microscopy.
- qPCR: PCR Extraction, ICP/MS, HPLC/UPLC, Bioreactors, Chromatography Systems, TFF Skids, Automated Robotics, GC/MS.
Representative Project Examples (Qualification Tag)
- SPARK THERAPEUTICS: Genesis provided qualification services for the gene therapy manufacturing spaces, ensuring equipment and processes met regulatory standards for commercial launch.
- cGMP BIOTECHNOLOGY FACILITY: A new 338,000 sf cGMP manufacturing facility would necessitate extensive qualification for all critical equipment and systems.
- BRISTOL-MYERS SQUIBB (Cambridge, MA): The R&D laboratory and office space fit-out would involve qualification of various lab equipment and systems.
