Colep, Europe’s largest contract manufacturer of aerosol products and printed packaging, has chosen industry specialist DHC Business Solutions for GAMP-compliant implementation of a company-wide standardized quality management system software. Initially, the DHC VISION products on the topics of document and training management (SOP), CAPA (measures), Audit Management andChange will be introduced at the Laupheim site. Colep relies on DHC’s best practice approach to software implementation and associated validation.
The focus is on ensuring compliance with regulatory requirements, such as those of the U.S. Food and Drug Association (FDA). A core element of the solution is the tamper-proof management and archiving of instruction documents and specifications (e.g. SOPs, manufacturing instructions, recipes, certificates, etc.) for Colep’s approximately 100 products in DHC VISION. To support the CAPA management software, complaints and deviations are recorded and appropriate preventive and corrective measures are initiated with system support. The use of the management software also enables the fully integrated execution of audits, the processing of resulting measures and the mapping of the complete change process for products, systems and processes.
“For us as a contract manufacturer, it is crucial that we can react flexibly to a wide range of customer requirements and do so without any further consulting services from the software manufacturer. DHC VISION gives us exactly that flexibility in the ease with which Colep employees can configure and extend the solution,” explains Robert Balla, Project Manager at Colep and responsible for Quality Applications there. “In addition, compared with other solutions at DHC VISION, the price-performance ratio for the software, implementation and operation of the system absolutely convinced us.”
The complete solution will be used productively as early as the middle of the 2nd quarter of 2015. As a result, in future all document-related processes will be mapped and managed in a central system, which, in addition to covering the complete document lifecycle, will also simplify compliance verification in audits.
Colep Laupheim GmbH & Co. KG
Colep, a member of the RAR Group, is a global leader in the consumer goods packaging and contract manufacturing industry. With 3,850 employees in Portugal, Brazil, Germany, Mexico, Poland, Spain, the United Arab Emirates and the United Kingdom, Colep generates turnovers of around 500 million euros. As part of “ACOA, the Colep & One Asia Alliance”, Colep offers customers a global supply network.