Validation

Webinar: "Software Validation: More Than Just the Vendor Documentation"

Computer System Validation (CSV) as per FDA guidance including 21 CFR 11 combined with ISPE’s GAMP has been an integrated risked-based approach for manufacturers for over 20 years. In 2022, GAMP 5 v2 and the FDA provided a new draft guidance for Computer Software Assurance framework, which amplifies CSV as follows:

  • Identify Intended Use
  • Determining Risk-based Approach
  • Determining Appropriate Assurance Activities

CSols has the expertise and experience to guide, define, and execute your CSV and Computer Software Assurance (CSA) needs.

Real-world Expertise

CSols’s validation experts understand the science, manufacturing, infrastructure, and instrumentation settings within your organization. We have expertise in regulatory agency audit processes and can tailor validation services to each client to reduce validation risk. 

Our understanding of real-world regulatory agency practices allows us to effectively and efficiently help you plan, implement, and verify a fully compliant, defendable system in any regulated computing environment.

This in-depth understanding reduces knowledge transfer time and gets your project started rapidly: we can quickly understand your regulatory needs, manufacturing environment, laboratory informatics and instrument systems, business and laboratory processes, information and data workflows, and how your computer systems and manual processes 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. We can assist you during any project stage, from concept to planning and executing, through operation and upgrades, and even system retirement.