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 of the documentation, assurance needs, testing activities and critical thinking has been planned and reviewed to ensure the system is fit for purpose. A risk based approach is key to ensuring patient safety and product quality is not compromised.
But computer system validation can also make some regulated companies anxious when implementing new software.
Qualsys Training Manager Kaye Eames said:
Recent GxP data integrity guidance published by the MHRA during early 2018 has really put the spotlight on validation. It's not just a requirement, it's a real hot topic at present.
Computerised systems should comply with associated guidance and regulations, and if this is not evidenced correctly or process not followed, this could have a critical impact on providing the validation steps of your purchased system and risk your business regulatory accreditation or license.
The responsible person will ask be asking the vendor:
- How am I going to manage resource to cope with validation?
- Does the vendor have a proven track record when it comes to CSV?
- Will validation requirements on an ongoing basis out-weigh the benefits of a new system?
Below, Qualsys have shared some computer system validation frequently asked questions. We hope this will give you confidence in our approach.
If you have any additional questions, please either ask one of our team or you can anonymously fill in the form at the bottom of this page and we will add to the post.
1) Is EQMS a validated tool?
Computer system validation is a regulatory requirement for FDA 21 CRF part 820.70 and EU volume 4 GMP Annex 11, 15.
The MHRA states: Vendor-supplied validation data in isolation of system configuration and users intended use is not acceptable. While the overall validation responsibility lies with the regulated company, Qualsys are committed to providing a thorough and fully supported validation partnership.
Many organisations have found our validation process delightfully easy - during implementation and beyond.
As an independent, Implementation and Validation Consultant, I have worked with Qualsys on several client projects, and can honestly say that they deliver over and above expectation. Read reviews here: https://www.capterra.com/p/150193/EQMS/ |
Qualsys helps support the validation process through:
- Risk assessments
- User requirements specification
- Functional specification
- Guidance of the configuration specification
- Testing of the critical user and configuration specification
- Functional testing
- Project management and support
It is your responsibility to:
- Assess the suitability, accuracy, and completeness of all documentation and amendments to ensure they are fit for purpose
- Testing of the critical requirements specification
- Sign off of the validation report
- Review of requirements periodically.
2) Which GAMP5 category is EQMS?
EQMS is a GAMP5 category 4 configured product.
|
Category |
GAMP5 |
Example |
|
1 |
Infrastructure Software |
Operating Systems |
|
2 |
No longer used |
Firmware |
|
3 |
Non-configured products |
Off the shelf software |
|
4 |
Configured products |
EQMS |
|
5 |
Custom applications |
Bespoke applications |
The characteristics of a category 4 computerised systems are:
- Standard interfaces and functions
- Functionality is configured around specific user and business processes
- Verification required:
- Requirements
- Functionality
- Configuration
- Testing requirements:
- User requirements testing
- Configuration testing
- Functional testing
3) How does Qualsys meet the GAMP5 principles?
| GAMP5 Principles of software validation | Qualsys approach |
| Requirements |
A documented software requirements specification provides a baseline for both validation and verification. Qualsys starts our validation journey with you before you even start implementing EQMS. Before we start working with any company who has GxP requirements, we will ensure there is a detailed user requirements specification document. Our technical teams go through every line of the URS to ensure our software meets your functional and configuration requirements. We provide user requirements specification (URS) templates to help you ask the right questions, or can refer you to industry expert eQMS / IBMS consultants who can help you develop a custom GxP URS.
|
| Defect prevention |
Software quality assurance needs to focus on preventing the introduction of defects into the software development process - not on trying to "test quality into" the software code after it is written. Qualsys takes a holistic approach to prevent defects. We invest heavily in a mixture of testing methods to ensure the development works as expected and meets the key requirements set out in the acceptance criteria. This reduces the risk of detectable defects and deviations from requirements. Testing includes, but is not limited to:
|
| Time and effort |
Qualsys knows validation takes time and effort. We don't just provide templates and then leave you to it. Chris Owen, Services Director at Qualsys says:
|
| Software life cycle |
Qualsys uses an agile software development life cycle (SDLC). Detailed requirements are collected from our software usability, external consultants, customer feedback and internal experts. These requirements are then scored and put into a two - three week sprint. |
| Plan |
Qualsys helps you bring all of your documentation together. The plan details what is going to happen in the validation process and when using the system. It contains the strategy to carry out the initial validation on the system along with any future upgrades/updates. It also contains the information on back ups, disaster recovery and any contingency plans. Documentation requirements:
|
| Procedures | Qualsys provides template procedures which identify specific actions or sequences of actions to be completed for individual activities, tasks and work items. |
| Software validation after a change |
As an integrated management system tool developer, we understand how important it is to understand how even small changes will impact the global system. Qualsys follows the ITIL change management methodology. This means we are able to innovate quickly with new features and functionality. As a Qualsys customer, you can choose when you want to upgrade with our release notes report. Full regression test reports are available.
|
| Validation coverage |
EQMS is usually classified as a mid-risk software tool for pharmaceutical, healthcare and biological customers. This means there must be documentation for various validation activities, tasks, and work items which need to be completed. |
| Independence of review |
Qualsys ensures a holistic approach to software validation. Qualsys also encourages all pharmaceutical, healthcare and biological customers to undertake independent evaluations. |
| Responsibility |
While the overall validation responsibility lies with the regulated company, Qualsys helps support the validation process through:
It is the customer's responsibility to:
|
4) How does Qualsys ensure best practice in CSV?
Qualsys follows GAMP 5 (7.1) supplier good practices e.g:
- Supplier quality management system must have a documented set of procedures and standards
- Activities are performed by suitably trained and competent staff
- Enable and promote continuous improvement
- Provide evidence of compliance with the documented procedures and standards
Qualsys also promotes a continuous learning culture. Our teams share best practices, formal industry training and lessons learned, so each of our customer benefit from our rich experience.
5) What support does Qualsys provide?
Qualsys provides the Installation Qualification and Operational Qualification. We can't completely do the Performance Qualification for you. But we do provide a library of test cases, or 'test scripts', which accelerates the time it takes for you to test your processes against the software.
Qualsys follow the GAMP 5 approach to computer systems validation
- Qualsys provide fully managed, flexible validation support package from start to finish
- Qualsys provide a full document template suite for all systems validation requirements
- Qualsys support you throughout the validation process and afterwards with expertise from extensive experience guiding customers around the world through the process.
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