ST4 ValiManager® - The Solution for Validation Documentation
The specialized solution ST4 ValiManager® for validation documentation in connection with GMP was developed on the basis of SCHEMA ST4 together with our partner HEITEC AG.
Areas of Application
- Pharma and medical technology is a complex area, requiring adherence to various laws, norms and guidelines.
- In Europe, the EU GMP (Good Manufacturing Practice) guideline defines the industry.
- In Germany, this guideline for pharmaceutical manufacturers is binding through the application of the German pharmaceutical law (AMG) and the Ordinance on the Production of Pharmaceuticals and Active Substances (AMWHV).
- In the US, the FDA's (Food and Drug Administration) guidelines, e.g. 21 CFR, part 210, apply.
- In the pharmaceutical and medical equipment industry, GAMP 5 (Good Automated Manufacturing Practice, version 5) is the standard guideline for validating computer-based systems.
In this risk-based environment, relevant business processes and system functions are subjected to risk assessments. With the active participation of the suppliers, scalable lifecycle activities, such as the scope of specification and verification, are derived from these guidelines. Tasks and responsibilities for management, development and operations are suggested by GAMP 5 as well. Specifications documents are matched to the respective verification processes. The responsibility for the whole process, however, lies with the operator who in turn must ensure that the supplier has done his job correctly. The responsible agencies and offices check the correct realization of the validation by the operator.
In order to speed up the creation process, creation of the extensive and structured documents must be (partially) automated, which can be achieved with the help of ST4 ValiManager®.
ST4 ValiManager® was developed on the basis of SCHEMA ST4. Thus it features all the functions of a modern, sophisticated editing system. In addition, ST4 ValiManager® boasts the following characteristics:
- Support for the creation and management of validation documents
- Content stored in a database for reuse
- Specification, risk and verification elements, creating the basis for all further documents
- Linked information, ensuring consistency
- Automatic generation of a traceability matrix
- Input options via manual input, Excel lists, and existing database content
- Validation documents produced automatically with a preset layout
We are pleased to offer you an extremely powerful tool, as well as expert consulting services for this subject. Further details can be found on the website of HEITEC AG.