In the pharmaceutical industry, GMP compliance is not a choice — it is a prerequisite. But what does that mean in practice for your inspection system? And why does it matter so much whether compliance is factored in at the end of a project, or from the very first design concept?
An inspection system that has to be made GMP-compliant retrospectively costs significantly more time and money than a system designed from the outset to meet those requirements. Think software validation (IQ/OQ/PQ), audit trails, user authorisation and change control. When those functions are layered on top of an existing system, inconsistencies arise that complicate validation and regularly lead to rework.
At Simac Masic we start every project with an analysis of the regulatory context: which standards apply, which documentation is required and what does that mean for the architectural choices in the system? That is not only more efficient — it is also the only way to deliver a system that passes the SAT without surprises.
An audit trail records every action in the system: who changed which parameter, when? In a recall scenario, that information is invaluable. But an audit trail added retrospectively rarely logs what you actually need. A well-designed audit trail is integrated into the core logic of the system.
Many manufacturers do not realise that “offline” programming — adjusting inspection programmes without stopping the production line — also has a compliance benefit. All adjustments can be tested and approved before going live, which greatly reduces the risk of process deviations caused by software changes. Our own software platform is specifically designed for this.
We work for manufacturers in the pharmaceutical industry, the medical sector and related high-tech industries. Want to know how we have found a solution for your type of situation? Get in touch or visit our expertise pages for more information about our approach.
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