System Suppliers, Operators and Qualification Hand in Hand
For over 40 years, WILUX PRINT AG as a purely Swiss manufacturer of labelling and marking solutions has been actively shaping its industry, supporting companies from industry, logistics and trade with solutions to optimize workflows, to shorten processes, to simplify handling and to save costs.
gempex supports WILUX Print AG.
For a company in the medical devices industry, a labelling system has to be developed that labels auto-injectors directly and, after blistering, the associa-ted packaging as well. The print data of the batch has to be sent directly to the printer, and OCR-based verification was desired.
Consultancy support was required to complete all phases of the qualification quickly and safely. GMP requirements had to be checked and supplemented, and the necessary qualification documents for the two systems had to be prepared.
In the first step, a URS was prepared and the basic GMP requirements were specified in it. On this basis, a Requirement Traceability Matrix was developed and evaluated with regard to risks. This central document was authoritative throughout all phases of the qualification process. The respective test points were clearly and comprehensibly assigned to the qualification phases and carried out.
Targeted support was also provided in the preparation of the FAT / SAT documents so that referencing to them became possible. Training of all parties at the beginning enabled close interaction between qualifiers, engineers and the QA department of the later system operator. The organizational framework has been set out, and defined workflows, release processes and regular jour fixes ensured a clearly structured process.
The intelligent design and integration of the FAT / SAT made it possible to complete the qualification in a particularly efficient, time- and cost-saving manner. Only critical points had to be verified during the qualification process, no tests had to be repeated. A successful project.
For questions on the subject of qualification, Frank Studt, Managing Director gempex GmbH, is available via firstname.lastname@example.org