Validation

Real-World Expertise

CSols’s validation experts understand the science, manufacturing, infrastructure, and instrumentation within your organization. We have real-world expertise in regulatory agency audits and can tailor validation services to each client to reduce validation risk and get your project started quickly. We take a holistic view of your regulatory needs, business and laboratory processes, and data workflows to understand what needs to be validated and what does not.

Systems and Instrument Validation

Our validation knowledge extends far beyond your LIMS, ELN, or CDS. Our multidisciplinary CSV consultants speak the language of your business, manufacturing and quality operations, and IT department.

Our validation expertise spans the applicable systems and instruments, as well as cleaning validation. Below are just a few we can validate for you:

Computer Software Assurance vs. Validation

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delivers CSV services using the GAMP®5 Risk-Based approach and are well prepared to make the switch to CSA when the draft guidance is enacted.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.

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 In 2022, GAMP 5 v2 and the FDA provided new draft guidance for the Computer Software Assurance (CSA) framework. Computer Software Assurance amplifies computer system validation by requiring the identification of intended use, determining the risk-based approach, and determining appropriate assurance activities. 

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

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.