The risk-based qualification of buildings, premises, systems, equipment and IT infrastructure forms an integral part of quality assurance in a regulated environment, and is also required by law (EU guidance on good manufacturing practice).
A planned and documented process must be used to demonstrate that the equipment and premises are suitable for their intended purpose, and actually function reliably under the real-world conditions applicable on site.
The execution of this process must be set down in written standard operating procedures (SOPs) and work instructions (WIs). The SOPs must describe all operations in a clear and structured manner, and be informed by risk-based principles.
An appropriately integrated qualification strategy can be used to avoid the duplication of work in departments that access shared IT services, so as to ensure the availability of consistent and qualified IT platforms. Another important aspect here is the integration of these measures into a company-wide Quality Assurance system.
DHC utilises the V-Model as its validation and qualification strategy. To this end, both the chronological sequence as well as the phases and documents relevant for risk-based publication are depicted:
- Design Qualification: Specification of the requirements for the equipment or the system. These include user requirements, as well as functional and design specifications.
- Installation Qualification: Documents the installation and commissioning of the system or machine, and demonstrates compliance with applicable regulations and required performance data as well as specifications.
- Operational Qualification: Equipment test or inspection process that assesses whether a system or piece of equipment is operating correctly.
- Performance Qualification: Field test that documents the deployment of the equipment in routine operations.