Computer System Validation
Whether you manage a facility in the pharmaceutical, biotechnology, or medical device industry, your computer system is the backbone of your day-to-day operations.
Leave the complexity to us
Keeping your system valid and compliant with relevant regulatory agencies protects the integrity of your data and the reputation of your institution.
Our Computer System Validation (CSV) support streamlines the process of validation so you can get back to your team and your operations.
The Validation Lifecycle, Simplified.
Don’t let operational challenges get in the way of innovation. Get a partner with a Quality Assurance (QA) mindset who can own the entire validation process.
ANSA provides Computer System Validation support to keep you up to date with:
- Periodic System Reviews
- Data and Metadata Workflow Verifications
- User Traceability
- Routine System Administration Duties
CSV Support for Laboratories
We manage the compliance and reliability of proprietary and Commercial Off-the-Shelf (COTS) software for laboratories. Our team offers comprehensive support with:
- Validation Life Cycle Document Authoring, including:
- Design Specifications
- Risk Assessment
- Trace Matrices
- Installation / Operational / Performance Qualification (IQ / OQ / PQ) Protocols
- Enterprise System Upgrades from Conceptualization to Implementation
- Data Migration Verification
- Good Automatic Manufacturing Practices (GAMP) 5 and GxP Assessments
- Network and Infrastructure Qualifications
- CSV Evaluation and Remediation
- Compliance with the Latest 21 CFR Part 11 Federal Regulations
- Database Design
Computer Systems We Validate
- Laboratory Information Management System (LIMS)
- Omnic Software
- Image Lab Software
- QX Manager
- ZX Explorer
- SoftMax Pro
- Chemstation OpenLab
- Magellan Tracker
- Agilent ECM
- Astra Software
- WinUV Pharma Software
- EasyMatch QC-ER
- Freedom Evo
- …And Many More
Get computer system validation with your industry’s needs in mind.
Validation is crucial for any Good Manufacturing Practices (GMP)/ Good Laboratory Practices (GLP) equipment that uses software to collect and report data. Meet GAMP requirements and stay at the forefront of your industry with CSV evaluation and remediation.
Contract Development and Manufacturing Organizations (CDMOs), pharmaceutical, biotech, and medical device industries count on the integrity of their manufacturing software. Maintain rigorous data standards with professional compliance support.
Enterprise Systems: LIMS, Empower, and MODA
Experiment data, asset management, and optimal workflow for Standard Operating Procedure (SOP) adherence are all simplified by properly implementing a great LIMS system. Partner with ANSA to leverage data and automation to set it up right from the start.
Your partners are our partners.
We provide a collaborative, end-to-end experience. Our team will work seamlessly with not only stakeholders, but with your SMEs and vendors as well. We collaborate to ensure that your processes and computer systems comply with the latest federal regulations and best practices.