First things first – why validation is so important nowadays?
The answer is simple – validated software is a regulatory requirement. For example, in a recently published 53rd WHO Expert Committee on Specifications for Pharmaceutical Preparations report requirement is described clearly “Validation is an essential part of good practices, including GMP and good clinical practices, and is, therefore, an element of the pharmaceutical quality system. Validation incorporates qualification and should be applied over the lifecycle of a product, process, method, or system.”
How we validate Flex Databases system?
To ensure the highest quality, we utilize best practices and modern approaches for system validation, aligned with regulatory requirements.
At Flex Databases, we begin with Validation Plan preparation at the early stages of the development process – usually, before or just after the user requirements to the system have been issued. It allows us to make the validation process smooth and take into consideration each little detail that could be important. We utilize a combination of Agile & SCRUM principles and release updates quite often to stay relevant to regulatory updates and technology latest trends.
We utilize data centers that have been assessed and added to the approved vendor list. To comply with regulatory requirements, ensure stable performance, and meet our clients’ expectations, selected data centers are located all over the world. For example, for the EU based clients, we offer Germany based data centers, that have successfully passed the GDPR audit.
The validation methodology is based on GAMP® 5 guidance.
According to the GAMP® 5, systems which are ready for Client-specific implementation can be classified as GAMP® 5 Category 4 ‘Configured Products’ from the end-user perspective.
GAMP® 5: Category 4 Approach:
22.214.171.124. of GAMP 5: “Regulated companies should decide upon the required levels of specification and verification, and many of the project phase activities and documents may be delegated. Since the system is configured for a business process, testing should be focused on this configuration”.
4.2.3. Appendix D5 of GAMP 5: “The results of the supplier assessment should indicate the supplier tests that have been performed and which ones can be leveraged to avoid unnecessary repetition or duplication of effort. The test strategy should incorporate or reference the results of such supplier assessments”.
How we help our clients with validation?
To optimize the Client’s GxP-regulated system validation effort, we share it by providing the following services and deliverables, in full compliance with all the applicable regulations and standards:
- Formalized User Requirements Specification (URS) for Flex Databases system, including 21 CFR Part 11 requirements for e-records and e-signatures. You can review and approve the URS and base your validation plan on it.
- Deployment of Client’s private cloud instance with Installation Qualification (IQ) documentation.
- As soon as the Client is ready to go to production, we will install the production environment on the Client’s private cloud. All system installations are accompanied by IQ package, summarizing actions performed.
- To make sure that all components of our computerized system validation process are in place, we arrange training for Client before granting the access. Training is made in accordance with our Quality Management System, all applicable regulations, and industry standards.
- Release of every new system version comes along with updated validation documents according to risk-based approach proclaimed by industry standards.
We base our validation approach on the traditional V-model, recommended by GAMP® 5. Our validation package includes:
Orange field marked deliverables may be provided by Flex Databases *marked deliverables are provided for a fee
Flex Databases provides supplier documentation to be included in the Client’s validation package:
- Validation certification for baseline module versions certifying the pre-validated status of the system ready to be implemented by an end user for the intended use
- IQ documentation
- OQ Testing Summary Report (client-specific configuration if configured by Flex Databases)
- Maintenance Plan (support, backup, DRP, maintenance procedures by Flex Databases)
- Training Certificates
- Vendor Qualification supportive documents:
- QMS Master Index
- 21 CFR Part 11 Assessment
- Other upon request or available for audit
All our validation documents are ready for Client’s review during an onsite or remote audit. We have successfully passed a lot of external audits by our Clients, including international CROs and pharmaceutical companies and independent auditors.
To get to know more about regulatory recommendations regarding validation, please visit:
- General Principles of Software Validation Guidance for Industry and FDA Staff: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation
- EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 11: Computerised Systems https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf
If you wish to know more about Flex Databases validation approach, feel free to drop us an e-mail to firstname.lastname@example.org, with the related subject line.