In regulated industries such as pharmaceuticals, cosmetics, and food production, the computer system validation plays a pivotal role in ensuring compliance with the regulations, customers’ and producer’s safety, and quality. The responsibility for this process belongs to the company that uses the computerised system in its production process. But as soon as the systems are purchased from a supplier, it is essential that this supplier also knows the industry it is selling into and the requirements of this industry. The system of these suppliers must be integrated seamlessly into the validation framework of the customer. This article examines the topic from the perspective of a supplier to customers in the pharmaceutical, food and medical device industries, with the challenges and solutions for customers and suppliers.

Regulatory Requirements
It always starts with the law – national laws and regulations such as the German Medicinal Products Act (Arzneimittelgesetz, AMG) or the German Drug Manufacturing Regulation (Arzneimittel- und Wirkstoff herstellungsverordnung, AMWHV), to name just two, make direct and indirect reference to the GMP regulations. Therefore, compliance with regulatory standards such as Good Manufacturing Practice (GMP), GAMP5 (Good Automated Manufacturing Practice), EU GMP Annex 11 or in the US sector with 21 CFR Part 11, is mandatory in regulated industries. These regulations outline the requirements for data integrity, traceability and system validation. While the customer bears the main responsibility for the validation of the overall process, the supplier must provide systems that enable this validation process and, ideally, make it as simple as possible for the customer.