Validation
Computer System Validation (CSV), per FDA guidance including 21 CFR 11 in combination with ISPE’s GAMP, has been an integrated risk-based approach for manufacturers for more than 20 years. In 2022, GAMP 5 v2 and the FDA provided new draft guidance for the Computer Software Assurance (CSA) framework. CSA is still very much risk based, but differs in approach in the following ways:
| CSV | CSA |
|---|---|
| Order of priority: documentation, testing, assurance needs, critical thinking | Order of priority: critical thinking, risk control, assurance, documentation |
| Methodology: Waterfall | Methodology: Agile |
| Testing: Scripted | Testing: Minimizing scripted and maximizing unscripted |
Computer Software Assurance amplifies computer system validation by requiring the identification of intended use, determining the risk-based approach, and determining appropriate assurance activities.
These are processes that CSols has always implemented in their validation approach, long before CSA, because determining the risk associated with each action helps with prioritizing the validation work and determining the testing effort. Our validation experts have many years of real-world expertise and experience to guide, define, and execute your CSV and CSA needs. As this is uncharted territory for many, you can rely on CSols to assist your organization with putting this critical new Guidance into practice.
Real-world Expertise
CSols’s validation experts understand the science, manufacturing, infrastructure, and instrumentation settings within your organization. We have real-world expertise in regulatory agency audit processes and can tailor validation services to each client to reduce validation risk.
This in-depth understanding reduces knowledge transfer time and gets your project started rapidly. We can quickly grasp your regulatory needs; manufacturing environment; laboratory informatics, enterprise, and instrument systems; business and laboratory processes; information and data workflows; and how your computer systems and manual processes integrate to bring all those activities together.
Clients tell us that their laboratory informatics systems, instrument systems, and computing environments were compliant and defensible more quickly and with fewer resources after working with CSols when compared to their experiences with generic CSV consultants.
~CSols Clients
Enterprise System Validation
Our multidisciplinary CSV consultants speak the language of your:
- business,
- your IT department,
- your enterprise systems: Manufacturing Execution System (MES), Quality Management System (QMS), and Learning Management System (LMS),
- as well as your laboratory informatics systems (LIMS, ELN, LES) and instruments.
CSols delivers CSV services using the GAMP®5 Risk-Based approach and are well prepared to make the switch to CSA when the draft guidance is enacted. We can assist you during any project stage, from concept to planning and executing, through operation and upgrades, and even system retirement.