ANSA Compliance’s strive for excellence has pushed us to expand our range of skills and specializations. While maintaining our stellar high standards, the ANSA team is proficient in a variety of validation processes that allow our clients to proceed in their manufacturing and deliverables.
ANSA Compliance supports laboratories with the following work:
Validation Life Cycle Document Authoring:
- GMP/GLP/GXP Assessments
- 21 CFR Part 11 Assessments
- User Requirement Specifications/Functional Specifications/Configuration Specifications
- Master Validation Plans/Validation Plan/Project Plans
- Risk Assessments
- Installation Qualifications
- Operational Qualifications
- Performance Qualifications
- Traceability Matrix
- Final Report or Summary Report
Laboratory Instrument Qualification and Validation:
- Validate COTS 1, COTS 3, COTS 4 and COTS 5 systems
- Simple and complex instrumentation Validation
- Instrumentation with custom coding and configuration
- Laboratory Instrument Experience including but not limited to:
- High-Performance Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), 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, and Colorimeters
Laboratory Equipment Qualification and Validation:
- Validate COTS 1, COTS 3, COTS 4 and COTS 5 systems
- Temperature Mapping experience with Kaye Validator
- Laboratory Equipment Experience including but not limited to:
- Controlled Temperature Units (CTU)
- Freezers 2-5C -40C, -50C, -70C and -150C
- Refrigerators
- Incubators
- Kaye Validator Experience
- 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
- Light Booths
Standard Operating Procedure Authoring:
- Work with the system owner to draft a step-by-step instructions to operate and maintain instrumentation and equipment.
- Draft and formulate procedures customized to methods, use cases, and safety.
- Always keeping in mind global and local client policies and procedures.
Administration Procedure Authoring:
- Draft administration SOPs with applicable software or firmware logical security, permission access rights and groups, backup, and restoration for instruments and equipment.
