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When an eQMS is implemented in a medical device company, such software must be validated.  It should be ensured that the system is working and that it meets the requirements of ISO 13485. Validating the software decreases risk and legal liability, and provides evidence that the system fits for purpose.


Software validation process

Validation for intended use documentation is useful for several reasons: ensures accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, resulting in fewer errors and less risk to process and data integrity.

These are the most common steps in the software validation process:

  1. Defining the requirements and producing requirements specification
  2. Selecting a reliable supplier
  3. Verifying the software's capabilities
  4. Validating the implemented system
  5. Changing control and re-validation
  6. Resolving deviations


The validation process can be considered as an additional burden for the companies since it takes a lot of effort to be completed. But, the qmsWrapper team is proud to provide the Validation documentation set to customers. This reduces the burden from our client’s shoulders by at least 80%.


qmsWrapper is validated according to ISO/TR 80002-2 Medical device software – Part 2: Validation of software for medical device quality systems. We have a dedicated validation team to take care of this part.


This set consists of System Requirements, Use requirements, Validation Report, and Validation against 21 CFR part 11 compliance documents.


qmsWrapper is cloud-based software, and it doesn’t require installation. So, the System requirements document provides information about the configuration that a system must meet in order to qmsWrapper software run smoothly and efficiently.


Use requirements document gives a detailed description of the use requirements for the qmsWrapper software. It includes a set of use cases that describe user interactions that the software provides. All Use requirements are tested (tests and performing steps are stated) and validation results are shown. It is basically a collection of test cases used to verify the proper functioning of a system.


The validation report explains the various activities performed as part of the testing of the qmsWrapper web application. Also provides the test results and the proof of the tests.


ERES Rationale explains compliance with FDA’s 21 CFR part 11 Electronic Records and Electronic Signatures.


qmsWrapper is pre-validated software. The user can state the vendor-provided test evidence and explain the details of provided validation package.


This being said, the logical question is what is the remaining 20% that should be done by the user end?


First of all, the validation protocol (SOP) should be written where the validation process is explained. It is clearly identified by regulations, both ISO 13485 and FDAs 21 CFR require it. The validation protocol provides instruction for determining when validation is required, and overall strategy. 


Requirement specification document as the description of a software system to be used for managing the company’s QMS, explaining expected functionalities from the QMS software.


Performing a risk assessment is one of the steps, that will have as an outcome documented risk factors and mitigations associated with using the software.


Software validation is like proof the eQMS is readily accepted and satisfies your requirements. In short, with the assistance of software validation, you know you’re using reliable and secure software.


There are no shortcuts in this process. However, qmsWrapper provides means for smooth validation saving clients time, nerves, and resources, but demonstrating compliance to regulations and standards.

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