Medical Device Software and Computerized System Validation
The Medical Device Software solution is developed by Knowllence in accordance with a Computerized System Validation (CSV) process.
This process is designed to demonstrate that our solution — the “computerized system” — is reliable and meets the expected requirements.
A validation file consists of a set of required documents that certify the quality of either Medical Device (MDS) software or tool software (used during the product lifecycle).
This validation file is essential for companies in the Life Sciences sector, including pharmaceuticals and medical devices.
A validation file for the standard version of Medical Device Software is created and maintained by Knowllence and made available to its clients.
What are the reference standards used for Computerized System Validation (CSV)?
The process implemented and followed by Knowllence takes into account, in particular, the requirements of the following reference standards:
- ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
- ISPE GAMP 5 Guide – A Risk-Based Approach to Compliant GxP Computerized Systems (ISPE, February 2008)
- ICH Q9 – Quality Risk Management (ICH, November 2005)
What does the validation file resulting from the Computerized System Validation (CSV) include?
This file is based on a continuous risk analysis conducted by Knowllence to identify potentially critical elements that require specific testing.
The validation file for Medical Device Software consists of:
- A Validation Master Plan (VMP) that defines the chosen validation policy.
- Validation Protocols and/or Reports (VP/VR) covering the following validation phases:
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Installation Qualification (IQ)
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Operational Qualification (OQ)
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Performance Qualification (PQ)
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Migration Qualification (MQ)
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Additional supporting documents
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Who performs Computerized System Validation (CSV)?
The different qualifications can consist of various parts.
For example, for Installation Qualification (IQ), an initial qualification (IQ1) is performed before the Operational Qualification (OQ). Then, a second and third Installation Qualification (IQ2 and IQ3) are carried out.
Depending on the environment chosen by the client (SaaS or On-Premise) and the allocation of responsibilities defined in the contract, Installation Qualifications 2 and 3 will be performed either by Knowllence or by the client.
Our clients can therefore choose to:
- Rely on the validation file provided by Knowllence to qualify the software. Everything that can be performed by Knowllence without the client’s final environment is included with the software’s “turnkey” version. Protocols for other qualifications to be performed in the client’s environment are provided. The client will only need to complete the evidence dossiers for these qualifications.
- Request additional services from Knowllence and receive support in qualifying the software, in addition to the validation file. This assistance can be either on an occasional basis or comprehensive.
- Rebuild the entire validation file themselves and define their own Computerized System Validation (CSV) approach.
To support you in your computerized system validation process, Knowllence can also provide you with a dedicated software platform. Contact us for more information!