Today, data comes from a wide variety of sources – and the stronger the digital systems are networked with each other, the more branched the data suppliers are. Plant and machine data, personnel recording, picking and material flow, customer portals and eShops have long been classics of decentralized data recording. But in the course of digitization, new sources are being added: the digital products themselves provide data and services, the machines provide more and more condition data, the supply chain provides information from the supplier’s supplier to the customer’s customer.
The data comes to us via the cloud or from mobile devices. This not only makes it increasingly important to know where the data comes from. It is even more important to check how the data originates. Because faulty recording and processing systems can spread their errors throughout the entire system. For example, incorrect information from a supplier’s system can propagate through the planning and production process to the customer and into the product itself. In the end, the origin of the error and the source of the error can no longer be determined.
For companies in the so-called life science industries – i.e. food and pharmaceuticals, but also cosmetics, medical technology and chemicals of all kinds – this problem has long been part of the daily business of planning IT systems. For example, finished food products must be traceable back to the suppliers of the components. This can only succeed if the deliveries of goods are recorded meticulously and batch-oriented. At the same time, however, the international quality guidelines in the life science industries also stipulate that all IT systems involved in production must prove that they are working properly. This includes, in particular, proof of the correctness of the data acquisition and calculation. The most important valid set of rules is GAMP – Good Automated Manufacturing Practices in its fifth version.
We at actesy have more than three decades of experience with the validation of computer systems in life science companies.
More and more, however, we can observe that validation is also finding its way into other industries – in the automotive industry, for example, where we have successfully completed a project to evaluate vehicle data. The validation of circuits and computerized elements is also becoming increasingly important in mechanical and plant engineering, in the electronics industry and in telecommunications. This means that the five largest industrial sectors in Europe are more or less directly affected by validation obligations. And as a rule of thumb, the more networking, the more validation.
Of course, at actesy we do not only have our customers’ systems in mind when it comes to validation. We have equipped our own metadata framework with built-in validation functions so that all applications and interfaces created with this development tool can be validated by themselves. We follow the guidelines of GAMP5, which applies to the life science industries and is increasingly used as a guideline for other industries. In addition, existing applications can be “post-validated” with the help of the actesy framework. Processes validated with actesy can be taught to the system if required. Thus, the validation of the systems can be easily carried out after the installation of adaptations, upgrades or release changes. The tests are automatically documented by actesy, just val easy.
We know: Trust is good, but validation is better – especially in a networked digital world. Therefore, with the actesy framework, we not only offer integration and development services for a digital world. With “Connecting Digital Worlds”, we deliver the necessary validation capability at the same time.
And what can we do for you?
We look forward to hearing from you at email@example.com
See you in your next digital project!