Regulated companies (i.e. pharmaceutical, biotechnology, medical device, etc.) are mandated by the FDA, Health Canada, MHRA, EMA and other regulatory bodies to perform Computer Systems Validation (CSV). CSV can be complex, time consuming, costly, and risky. Not properly validating your laboratory information systems (LIMS, ELN, LES, SDMS, CDS, Other Instrument Systems) can result in:
- Warning letters – 483
- Consent decree(s)
- Lawsuits / Fines
- Plant shutdown
- Economic instability
- Staff downsizing
- Product recall
Your lab information system validation must be executed and documented fully and your process and evidence must be capable of passing an audit by trained regulatory inspectors.
How we can help you validate your laboratory information systems
CSols’ validation team is comprised of highly skilled scientists, information technologists, and regulatory experts who specialize in the validation of laboratory information systems such as; LIMS, ELN, LES, SDMS, CDS, and other laboratory instrument systems. CSols’ laboratory information validation consultants have extensive real-world experience and knowledge of the practices of regulatory agencies (FDA, MHRA, EMA, Health Canada). We deliver our laboratory informatics validation services based on the GAMP 5 Risk-Based approach and manage your validation project using our PMI-derived Project Management Methodology. Read more…
CSols’ Computer Systems Validation (CSV) Services
CSols offers a full portfolio of laboratory information systems Validation Services including:
- Validation Planning
- Validation Lifecycle Servies
- Validation Testing and Verification Services
Benefits derived from CSols laboratory information systems validation services
CSols’ laboratory computer systems validation consultants are not only regulatory experts but are also experts in the inner workings and functionality of laboratory informatics and lab instrument systems (LIMS, ELN, LES, SDMS, CAPA, CDS, etc.) as well as how these systems are used in laboratories. We leverage this knowledge and our extensive real world experience in how regulatory agencies like the FDA, Health Canada, MHRA, and EMA operate to deliver superior laboratory information system CSV services and deliverables in less time, utilizing less of your staff’s time, and at lower cost compared to what generic validation consultants provide.
- High Quality Validation Plans – not a generic plan but one that truly reflects laboratory informatics CSV best practices based on your Quality Culture.
- On Target Risk Assessments – accurate and informed risk assessments that identify the functions and features that should be tested and the optimized testing level for each.
- Thorough Test Scripts – test scripts that not only completely exercise the requirements but that reflect real scientific utilization and failure scenarios.
- Detailed Documentation & Reports – clear and concise documentation and reports of the CSV process and testing in a format that will help you pass an audit.
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.
At CSols, we practice Excellence by Design. When we work with you to validate your LIMS, ELN, LES, SDMS, or instrument system we will infuse excellence into your laboratory informatics validation process, plans, scripts, and documentation. Your readiness to defend against audits will be excellent.
Rather Talk To Someone?
If you’d like to discuss your options and needs for the Validation of your Informatics system, we’d be happy to talk one-on-one with you.