CSols knows regulated companies (i.e. pharmaceutical, biotechnology, medical device, etc.) like yours are mandated by the FDA, Health Canada, MHRA, EMA and other regulatory bodies to perform Computer Systems Validation, which can be complex, time consuming, costly, and risky. And not properly validating your scientific software systems can result in one or many of the following:
- Warning letters – 483
- Consent decree(s)
- Lawsuits / Fines
- Plant shutdown
- Economic instability
- Staff downsizing
- Product recall
How We Can Help with Your CSV
CSols’ CSV consultants are not only validation experts from the regulated industry, but experts in the inner workings and functionality of laboratory informatics and instrument systems as well, such as: LIMS, ELN, LES, SDMS, CAPA, CDS, etc. Our team leverages this knowledge with extensive real world experience with regulatory agencies like the FDA, Health Canada, MHRA, and EMA to deliver superior CSV services, reducing the amount of risk involved in you project, utilizing less of your staff’s time, and delivering higher value compared to generic validation consultants. Our expertise, experience, and approach ensures your laboratory informatics systems, instrument systems, and computing environment will be compliant and defensible. Read more…
CSols’ Computer System Validation Services
CSols offers a full portfolio of Computer System Validation Services including:
- Validation Planning
- Validation Lifecycle Services
- Validation Testing and Verification Services
Benefits From CSols’ Computer System Validation Services
Our broad computer system validation services portfolio is delivered using our PMI-derived Project Management Methodology. This proven methodology which is continually tweaked based on best practices, provides exceptional oversight and peak project efficiency. The combination of our knowledge, skills, and processes has delivered fully defensible laboratory informatics and instrument systems as well as peace-of-mind for our clients.
- System Specific Validation Plans – not generic plans that are one size fits all, but plans that truly reflect laboratory informatics CSV best practices based on your intended use and Quality Culture.
- On Target Risk Assessments – accurate and informed risk assessments that identify specific functions and features that should be tested and the optimized testing level for each.
- Thorough Test Scripts – test scripts that completely exercise your user requirements and specifications with scientific utilization and failure scenarios unique to your intended use.
- Detailed Documentation & Reports – clear and concise CSV lifecycle documentation following a GAMP 5 risk-based approach according to software categories throughout your project in a format that will help you pass an audit.
At CSols, we practice Excellence by Design™. When we work with you to validate your laboratory systems we infuse excellence into your processes, plans, scripts, and documentation so your readiness to defend against audits is excellent, by design.
If you’d like to talk more about computer system validation in your Lab, let’s find a time to chat.