Laboratory Validation
Safety, compliance, and methodologies are the lifeblood of your laboratory facility. Take no chances.
We keep you Innovating.
Safety, compliance, and methodologies are the lifeblood of your laboratory facility. Take no chances.
ANSA supports Food and Drug Association (FDA) and European Union (EU)-regulated Good Laboratory Practices (GLP) / Good Manufacturing Practices (GMP) / GxP laboratories and complete laboratory management from the ground up. Get a partner who leads you through the construction, commissioning, and validating phases.
Validation management that keeps you innovating.
We understand what it takes to keep your equipment and facility operating at the highest standard.
Lab-Experienced Staff Hit the Ground Running
We understand your specific challenges and know how to navigate the road ahead. Our experienced staff has robust laboratory backgrounds, enabling us to understand the equipment, processes, and most efficient routes to validation while considering the end-user experience. Whether you’re starting or expanding your lab, our advantage becomes your advantage.
Laboratory Instruments and Equipment We Validate
Whether your laboratory instruments are simple, complex, or feature custom coding or configurations, we have the validation support you need for any system.
- Commercial Off-the-Shelf (COTS) Systems: COTS 1, COTS 3, COTS 4, and COTS 5 systems
- Temperature mapping
- Laboratory instruments, including:
- Viable Particle Counters and Non-Viable Particle Counters
- High-Performance Liquid Chromatography (HPLC)
- Ultra Performance Liquid Chromatography (UPLC)
- …And More
- Liquid Chromatography-Mass Spectroscopy (LCMS)
- Gas Chromatography (GCMS) FT-IR Spectrophotometers
- Density Meters
- Capillary Electrophoresis Instrumentation
- Liquid-Handling Robotic Instrumentation
- Endotoxin Instrumentation
- PCR Sequencers
- Bacterial Identification Systems
- Evaporative-Light Scattering (ELSD) Detectors
- Photo-Diode Array (PDA) Detectors
- Ultra-Violet (UV) Detectors
- Spectrophotometers
- Charged Aerosol Detectors
- Nitrogen Analyzers
- Balances
- pH Meters
- Gel Imagers
- Plate Washers
- Plate Readers
- Total Organic Carbon Analyzers
- Particle Size Analyzers
- Colorimeters
- Laboratory equipment, including:
- Controlled Temperature Units (CTU)
- Freezers 2-5C, -40C, -50C, -70C, and -150C
- Refrigerators
- …And More
- Incubators
- Kaye Validators
- Stand-Alone Temperature and Humidity Loggers
- Fume Hoods
- Bio-Safety Cabinets
- Light Booths
- Purified Water Distribution Systems
- Utilities, Including CO2 and Process Air Distribution Systems
Document Creation for the Lab Validation Life Cycle
We assess, improve, and author documents and processes you need to keep your laboratory compliant with any relevant regulatory agencies.
- GMP/GLP/GXP Assessments
- 21 CFR Part 11 and EU Annex 11 Assessments
- User Requirement Specifications, Functional Specifications, and Configuration Specifications
- Master Validation Plans, Validation Plans, and Project Plans
- Risk Assessments
- Installation / Operational / Performance Qualification (IQ/OQ/PQ) Protocols
- Traceability Matrices
- Final Reports or Summary Reports
Administrative Support for Laboratory Validation
Expertly authored processes are crucial for keeping lab facilities safe, efficient, and in compliance with regulatory requirements. Leave the paperwork to us.
Standard Operating Procedures for Labs
Our process is collaborative. ANSA works with you to create a step-by-step system for operating and maintaining laboratory equipment. We draft and formulate procedures customized to your facility’s methods, use cases, and safety needs, always with global and local client policies and regulations in mind.
Administrative Procedures
Get help maintaining comprehensive operating procedures. We draft administration Standard Operating Procedures (SOPs) for any applicable software or firmware for your lab’s instruments and equipment.
Get a lab partner.
