If you use laboratory informatics software (e.g., LIMS, CDS) in your regulated lab, it must be validated. A fully documented validation is the only way to provide evidence that your software operates according to how it was developed and that it’s fit for purpose based on your intended use. Otherwise, any data you collect, analyze, report or store will be considered at risk and likely out of compliance. CSols wants to make sure you achieve excellence, whether you are just getting started with CSV or stuck somewhere along the way. We are here to help and will be your trusted partner.

How do you know if you need help with your Validation?

Do you find yourself asking these questions?

• What else do I need to do outside of what the vendor provided?
• We are moving from R&D to a regulated environment where validation is required – what does that mean?
• The auditor said our systems are not fully validated – how do we close our gaps?
• My validation project is dragging and taking forever; what can we do to get it finished?
• The last validation we did took forever, and we want it to go quicker this time – how do we find a better way?
• We de-scoped a lot to meet the go-live date; what do we do if we want to go back and add that functionality into the system?
• Our validation resources quit or have been reassigned – how can we augment our staff to meet our go-live date?
  
  

Achieve your validation goals

• A validated system that will pass an audit
• Validating everything that’s in scope
• Complete the validation on time and on budget
  
  

Services and Deliverables = Peace of Mind

Our unique CSV services portfolio combines our industry experts’ experience with CSols’ risk-based Computer Software Assurance (CSA) approach and methodologies, resulting from ever-evolving best practices. This proven combination delivers peace of mind for our clients.

Processes that Deliver Excellence 

• Full CSV support—from strategic leadership and managing your project, to augmenting your staff of experts for specific needs
• Follow GAMP, industry best practices, and a risk-based CSA approach
• PMI-derived project management process
• Experts in prospective and retrospective CSV and remediation
  
  

The Value CSols Brings - Our People

• Tenure and Breadth: Highly skilled and experienced (avg 15 yrs) scientists, information technologists, and regulatory experts (GxP, FDA, 21 CFR Part 11, etc.)
• FDA/EPA Ready: Real-world regulatory bodies’ practices expertise; you get a fully compliant, defendable laboratory informatics environment
• Scientific/Laboratory Backgrounds: We understand your lab processes/workflows, scientific data, and the underlying science, so we are better able to develop realistic test cases and perform risk assessments
• Product Experience: We are experts in the leading COTS informatics software systems, so your internal resources’ involvement is minimized when we are creating or executing test cases

.

It’s time to see the full picture of Computer System Validation. Let’s Talk.