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PacOnline and GMP
The application of digital systems in the artwork process for manufacturers of medication, food additives, cosmetics, and foodstuffs are subject to the special regulations of such governing bodies as EMEA (EU) and the FDA (US Food and Drug Administration). The focus for both is on GMP (Good Manufacturing Practice). The FDA also demands that both hardware and software (and also their respective development processes) comply to GMP guidelines.
In Germany, the specifically German "V” Model guidelines based on US methods have been developed for application to the generation of automated systems. We at Spirit see in these tight regulations the opportunity to develop high-end products and provide good service. System validation
Validation of a software, through which proof is established that the software is able to perform the purpose for which it was designed, forms the basis for the application of PacOnline® in a GMP-relevant context. Companies themselves are responsible for the validation of the software in application. Achieving validation is a task shared by a dedicated team together with the in-house IT department. Our detailed understanding of both aspects put us in a position to provide valuable assistance with system validation, both regarding best practice in artwork life cycle management processes and in handling IT questions in relation to technical requirements and their implementation.
Validation of IT systems requires that not only the software but also the development process itself comes under scrutiny and needs to satisfy high demands. Both PacOnline® and its process of development meet the GMP guidelines of both the EU and the FDA. PacOnline® meets current regulations regarding electronic records and signatures (ER/ES) handling. PacOnline® complies to 21 CFR Part 11.
We are also able to support our customers in automated test procedures. This enables companies to satisfy validation requirements to GAMP guidelines in each instance via a straightforward and automated procedure and to estimate the effort required. Far from being left unaided when your system is launched you thus enjoy our active support. |
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Software development to the „V“ Model
Software development according to the German „V“ Model approach makes provision for a train of operational steps, split into a development and a test phase. The individual steps in the development phase correspond to individual steps in the test phase and need to be reconciled with those steps. The graphic representation of this results in a "V".
Sequencing the operational steps and pairing the development and test steps is designed to satisfy two different aims:
- At the development stage, the software specification is worked out in a number of steps so that the user's functional specification can be transformed into the developer's technical specification. This approach ensures the formulation of a practice-related description of intent, the implementation of which is technically feasible.
- Pairing operational levels means that appropriate tests can be defined at each step. These tests serve to determine that the software will deliver the functional performance required.
The „V“ Model approach facilitates realization of targets for those involved in the project, while enabling appropriate checking mechanisms at each stage. In developing our software, we work strictly in line with this development system, which is GMP compliant. Our QA system complies to the standards of the pharmaceutical sector and has been successfully audited both independently and by customers. Validation of our software has also been successful. This approach gives project teams the confidence in forward planning they require and also the certainty that system validation will be successfully concluded.
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