Validation of computer-based systems and software: how to make the process efficient

Can a computer-based system or software achieve its intended use? This is a fundamental question for manufacturers of medical devices, which must be answered by validating these systems. EN ISO 13485:2016 requires the validation of software applications and computer systems used for the development and manufacture of medical devices.

The aim is to check by objective means whether specified users achieve the specified usage goals in the specified usage context. Validation is to prove that the installed software system functions as expected in the intended operating environment and that the process requirements are fulfilled in a comprehensible way.

Process validation is intended to ensure that conceivable hazards for patients, users or third parties are not overlooked as soon as software systems are used. This ensures the quality of medical devices.

As a component of the technical documentation, validation is not only subject to the requirements of the ISO 13485 standard, but also to the detailed specifications of the MDR 2017/745 and the continuous obligation to keep it up to date.

How you can accelerate the validation process efficiently and sustainably? BAYOOSOFT Risk Manager is based on the GAMP 5 guidelines for computer-aided validation and is validated as Category 4 software. In comparison: If you use solutions such as Microsoft Excel or Word files for development in risk management or product documentation, you have to validate them.

Do you already know the Pre-Validation Package?

Time saving: As part of the Pre-Validation Package, you receive a Quick Start Guide which supports you in carrying out the validation process quickly and effectively.
Streamline processes, save costs: You receive over 500 pages of prepared validation work for your sustainable and standard-compliant documents.
Sustainability included: All necessary updates are included with every software update for re-validation
Special Service: With a special service package, we can take over the validation of BAYOOSOFT Risk Manager according to GAMP 5 for you on request.

We support you with the validation of the software: Learn more here.

As a validated approval accelerator, the BAYOOSOFT Risk Manager supports you in the compliant creation of technical documentation. In a clearly structured environment, all relevant information is recorded, stored centrally in an audit-proof manner and linked dynamically in a fine-granular manner.

You would like to get to know the BAYOOSOFT Risk Manager without obligation? Take advantage of our 30-day TRIAL.

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Validation of computer-based systems and software: how to make the process efficient

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