ATS Life Sciences Systems offers high-quality automation solutions for manufacturers of medical technology and pharmaceutical products, for whom compliance with regulations is a priority. With more than 45 years of experience, 5 locations worldwide, and 1,600 employees, ATS develops automated manufacturing assembly and handling solutions. ATS Life Sciences Systems is a division of ATS Corporation, an industry-leading automation solutions provider to many of the world's most successful companies.
gempex has been supporting ATS in various projects such as newly designed plants or modifications to existing plants for several years. The aim is to balance out peak loads and provide competent and compliant support for the upcoming qualification tasks.
To strengthen the resources of the internal validation department, gempex takes on tasks related to the qualification of new and existing plants as well as routine tasks. The systems configured according to customer requirements, such as palletizers or material handling systems, must be described in detail in design documents such as functional, software, and hardware specifications. Traceability matrices and risk analyses must also be created for the specified systems. Based on this, test protocols for IQ and OQ must be developed and executed. Change controls and requalifications are also part of the scope of tasks. Competent manpower for qualification tasks.
Integrated into internal processes and structures with a high level of trust, the ATS team was reinforced with up to three colleagues working either remotely or on site. Qualifications were also conducted at machine locations in other European countries, always in close cooperation with the customer's project management and internal validation department.
Thanks to the flexible deployment of qualified personnel, ATS can reliably fulfill quality management tasks even during peak order periods. Qualification documents are reliably provided on time for the delivery of the systems in accordance with customer specifications and within schedule for the delivery of the plants.
Key Performances of gempex were:
- Qualification IQ, OQ
- FMEA
- Requalification
- Change Control
- Traceability Matrix
- Test Protocols
- Onsite Execution
For any questions about qualification management during peak order periods and support through resource reinforcement, Thomas Raaf, Manager Onsite Execution, will be happy to be contacted via contac@gempex.com..
This might also interest you:
Onsite-Execution