Short description:

In preparation for the re-certification of the IT service provider (customer) according to ISO 13485, tools used by the customer in the creation of life science software are to be validated. The document management system (DMS) 'docuvita' and the application lifecycle management system (ALM) 'SpiraTeam' are to be validated. The DMS is to ensure versioning and audit-proof storage for project documents and to run through the configured approval process without errors. The ALM tool is to manage the project lifecycle and support teamwork. Artifacts for project planning and tracking shall be traceably managed correctly through configured workflows. The ALM tool shall ensure the correct application of project-specific user rights. As a result of the software development process, the ALM tool shall deliver document content (e.g., specifications, verification plans and reports). Data protection and security must be ensured by both tools.

Supplement:

The ISO 13485 standard defines the requirements for quality management, which must be applied in the manufacturing of medical products. The software products manufactured by the customer for example for the healthcare sector, for medical technology as well as for diagnostics and the pharmaceutical industry are affected by these requirements. PTA is responsible for the project, including the planning, execution and completion of the validation as well as the tracking of open points (findings) for the manufacturers of the validated standard software tools.

Technical description:

Both systems (DMS and ALM) are standard software that is tested according to validation rules defined in standard operating procedures (SOPs). This ensures that the regulatory requirements for the development of life science software are met, which means that verifiably reliably safety tools are used. During a complete validation (after evaluation of changes to the standard software and alignment with user requirements), the planning of validation activities is documented; test cases are created or modified. After the validation plan has been approved, the tests are executed and occurred deviations are reported. The validation report summarizes the results and prioritizes required actions. Finally, in accordance with the SOP Computer System Validation, the responsibilities are defined and the work instructions are revised and made productive.