Validation Statement

Why validate?

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.”

Clinical trial industry welcomes the long-awaited EMA Guideline on computerised systems and electronic data in clinical trials https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-computerised-systems-electronic-data-clinical-trials_en.pdf , so far in draft, but expected to be finalized by December 2021.

What is of special interest for us in this highly informative and well-structured document?

All computerised systems used within a clinical trial should be subject to processes that confirm that the  specified requirements of a computerised system are consistently fulfilled and that the system is fit for  purpose. Validation should ensure accuracy, reliability and consistent intended performance, from design until decommissioning of the system or transition to a new system. (DRAFT EMA Guideline on computerised systems and electronic data in clinical trials)

Flex Databases remains your trusted partner in computerized systems validation.

 How do 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 and Finland-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 that 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:

4.2.6.2. 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 do we help our clients with validation?

The sponsor is ultimately responsible for the validation of the computerized systems used in clinical trial processes. They may rely on qualification documentation provided by the vendor if the qualification activities performed by the vendor have been assessed as adequate, but may also have to perform additional qualification/validation activities based on a documented risk-assessment e.g. during pre-qualification audits (DRAFT EMA Guideline on computerized systems and electronic data in clinical trials)

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 an IQ package, summarizing actions performed.
  • To make sure that all components of our computerized system validation process are in place, we arrange training for the Client before granting the access. Training is made in accordance with our Quality Management System, all applicable regulations, and industry standards.
  • The release of every new system version comes along with updated validation documents according to the 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:

Validation deliverables

We provide all the necessary documentation to be included in the Client’s validation package:

  • Validation Summary Report for all our validation efforts as system developer
  • User Requirements Specifications
  • OQ Testing Summary Report
  • User Manual
  • Release Notes
  • IQ documentation
  • Maintenance Plan
  • Training Certificates
  • And we do provide the necessary documents ensuring you are aware of and control all the changes implemented into the system after the first release to production

Definitely, there are more internal documents keeping track of every step during software development – we are always ready to provide them for review during the audits.

UAT Scenario can be provided to make your PQ stage (end-user testing) easier. To make it smoother and quicker we are ready to guide you through the system during your user acceptance testing.

For the responsible party to use the vendor’s qualification documentation, they should have a thorough  knowledge about the vendor’s quality system and qualification activities, which could usually be obtained through an in-depth assessment/audit. (DRAFT EMA Guideline on computerised systems and electronic data in clinical trials)

Flex Databases QMS System covers all the processes and allows us to help our Clients with vendor assessment and provide the full range of supportive documents: QMS Master Index, training files of employees including CVs and Job Descriptions, 21 CFR Part 11 Assessment,  are available for audit, as are other documents upon request.

Flex Databases is ready to schedule your audit (onsite or remote), to book one please drop us an email at contact@flexdatabases.com. 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:

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