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| Software Development Life Cycle Support with ProQuMaS |
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Our goal is to ensure the highest quality for our software even while we are still
in the process of developing it. For this reason, our quality management focuses
specificially on the Software Development Lifecycle (SDLC) of our PAS-X projects.
Our software development process follows a clearly structured, high-quality procedure
providing detailed evidence of all development activities.
To support this complex process, we use our software tool ProQuMaS (Project Quality Management System) in our
projects. This tool is in use from the very first day of a project and it generally accompanies the entire
lifecycle of the specific MES solution.
ProQuMaS is a software application that manages all the documents that are created and maintained in
the course of the Software Development Life Cycle. This includes storing, versioning, and releasing the
associated documents. ProQuMaS ensures that any changes in the SDLC documents and the related test cases
are recorded to ensure traceability. In addition, ProQuMaS also keeps track of the relationships between
the documents (referencing).
ProQuMaS supports all SDLC phases:
- Planning
- Specification
- Development
- Verification
and also the appropriate change management.
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EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
The Chapter 4 'Documentation' introduces documentation principles:
"Good documentation constitutes an essential part of the quality assurance system. (…) To facilitate control, traceability and referencing, each document should carry a unique identification 'label' for title and version."
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| The individual SDLC Functions |
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- System Requirements
ProQuMaS ensures that the system requirements are integrated in the SDLC documents. To make this possible, the formal user requirements and business process steps are entered into ProQuMaS.
- Business Process Approach
The process steps defined in the Business Process Description refer to Use Cases defined in the Functional Specification (FS) (implemented, system-supported workflows). Use Cases, in turn, refer to the system functionality (User Functions) defined in the FS.
- Product Approach
The Functional Specification can be derived from the PAS-X system description so that it does not have to be created from scratch for every project. During the functional specification phase, the FS is adapted to reflect the customer requirements resulting in a "TO-BE" description. During this process, any changes with regard to the original product are recorded and marked. When the requirements change during the implementation phase, the description will be updated. Once the system is completed, the description is considered "AS IS".
- Risk based Approach
ProQuMaS supports the risk-based approach.
The software allows for a Failure Mode and Effects Analysis (FMEA) of all three SDLC aspects
(changes, system functionalities, and processes). You can define mitigation actions for
minimizing risks and assign them to the appropriate verification phases.
- Change Management
Formal Software Change Requests (SCRs) are created in ProQuMaS to manage any changes and process them via workflow control. SCRs are subject to the risk-based approach. They reference the FS (system functionality) and are linked with the Test Specifications via Mitigation Actions in order to minimize risks.
- Software Release Management
ProQuMaS defines Software Releases and links them with the appropriate SCRs, the relevant FS versions and the associated Risk Analysis with the related Test Plans. This makes sure that the Design Qualification for each software release can be managed accurately.
- Going Live
ProQuMaS supports all the processes involved in the commissioning and start-up phase. . This includes creating instructions for installation, configuration, and administration
- Verification / Validation
ProQuMaS supports all the verification and validation phases. You can use ProQuMaS to create Test Specifications for every phase. You can create several test specifications with a number of Test Cases per Test Phase.
- Design Qualification
ProQuMaS supports the Design Qualification (for each software release) via traceabilities between the requirements and the system description and also between mitigation actions (from the Impact & Risk Analysis) and the test specifications.
- Software Design
ProQuMaS links the system description (FS) with the Software Design via a parameterizable traceability to connect with the design elements (e.g., service, views).
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