Many regulated companies, such as those in life sciences, food and beverage, and the cosmetics industry, worry about time and resources required for software validation.
For many of our customers, having a validation process which verifies that your systems are compliant and fit for purpose is critical to compliance with legislation and standards.
Our validation methodology is designed to significantly reduce time and effort involved in your validation process. From developing your user requirements specification (URS) to performance qualification (PQ), we offer an end-to-end validation service to ensure you are compliant. We also help you set up a validation process so that when there are system upgrades or you need to make any changes to your processes, you can properly validate your systems in the future.
Our team of implementation experts have an established process which is then tailored to meet your internal requirements.
Less internal resource
We are here to help with validation master plans, test scripts and checklists so you save hours.
Become an expert
Our highly trained, knowledgeable teams will talk you through each part of the process and teach you how to implement and maintain the software in a secured and validated state.
Confidence in your approach
We know the pressure of complying with the regulations and we understand the value of having a knowledgeable third-party expert to provide assurance in your approach.
Best practice implementation
Our services ensure re-validating your system is structured, easy and efficient.
Reduce compliance burden
Our thorough validation process will reduce your workload in the long term.
Our validation services are a 5-part process:
- Plan: Involves building / updating the user requirements specification (URS), functional specification and supplier assessment.
- Build: The Installation Qualification (IQ)
- Configure: The Configuration Specification (CS) and configuration plans.
- Test: The Operation Qualification (OQ), includes administrator training, user training and on-boarding plans.
- Review: The Performance Qualification (PQ), Standard Operating Procedure (SOP) review and change control.
- Validation master plan
- Validation checklist including IQ, OQ and PQ
- Validation process support
- Validation training
- User requirements specification
- Traceability matrix
- Risk assessments
- Configuration plans
- Test plans, test scripts, test results
- Go-live certificates
- Validation report
Request the validation brochure to get information about:
Our five-phased approach to managing computer systems validation
How our software enables you to comply with regulations and Standards such as ISO 13485:2016, GAMP 5, ICH GCP E6, FDA 21 CFR Part 11, and the EU Electronic signatures directive.
How our validation package saves you time, energy, money and internal resources.
Chris Owen, Services Director at Qualsys explains:
What is software validation?
When is it necessary to validate quality management software?
Requirements for ISO 13485:2016 validation
How Qualsys can help with the validation