Our methodology

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.

Complex circle

Our validation services

Dedicated support

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. 

A thorough validation service

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 support services

  • 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

Read our brochure about the software validation process

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.

Interview with Qualsys's Director on ISO 13485 validation

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

Questions about our validation services? Request a call from a domain expert here.

Recent articles about computer systems validation

Computer system validation: The Qualsys approach
Computer systems that are used to support regulated processes in the pharmaceutical, healthcare and biological industry need to comply with the expectations of the regulatory authorities. One of the most crucial requirements is computer system validation. This is the umbrella term for ensuring all ...
Read more
ISO 13485 software validation process
When you're implementing an electronic medical device quality management system, your software validation plan is of the utmost importance. You'll need to ensure that your system is working and continues to work as required.
Read more