ACS are recognised as value adding suppliers to the Pharmaceutical industry with some of the world’s largest pharmaceutical companies having benefited from our skills and service.
The pharmaceutical industry is a very controlled and demanding environment, where our client’s ability to get a product to market quickly and efficiently is critical to maximising profitability. Organisations in this sector are continually looking at maximising the product changeover times and yields of their production plant, whilst retaining the absolute quality required that is the key driver in this industry.
ACS work to the guidelines as detailed within the GAMP4 model, (Good Automation Manufacturing Practices) ensuring that full traceability of all sections of our work is available at each stage of a project.
With many of the leading pharmaceutical organisations now requiring plant production data in an electronic record form, it is necessary to subscribe to the “Electronic Records and Electronic Signatures” regulations established by the US Food and Drug Administration (FDA 21CFR Part 11). ACS is fully conversant with this document and can assist you with compliance.
All systems that are supplied are provided with the necessary design and documentation to readily carry out validation, either by ACS personnel or a 3rd party.
All software associated with PLC’s is engineered using the industry standard – IEC 1131. Our procedures have been the subject of strict pharmaceutical company audits, and our knowledge and experience of this sector is proving to be an increasing part of our business.