Toward a paperless plant?

Andrew Bond, our European Contributing Editor, brought my attention to this piece by old friend (our fathers knew each other, for Pete's Sake!) Eoin O'Riain in Readout:Eoin Ó Riain of Readout writes: Pharmaceutical manufacturing is set to move from a supply chain model to a value chain model, generating a need for a new collaborative manufacturing approach incorporating manufacturing productivity improvement and a risk based approach to compliance, ARC's Simon Bragg told a Pharma MES day entitled "˜The Paperless Plant Has Arrived' and organized in Cork, Ireland last month by German MES specialist Werum. Werum has developed particular expertise in such key areas as production management for regulated industries, test data management systems and customized IT solutions. It has recently completed expansions of its PAS-X MES installations at Genzyme and Nycomed Pharma (formerly Altana), implementing MES functionality and integrating it with the existing automation and ERP layers. Key lessons According to Nycomed's Graham Clarke and his team, key lessons learned on the project at the Carrigtwohill, Co Cork plant were the importance of using as many manufacturing personnel as possible in the qualification stage, the challenge of running start-up and an MES project in parallel and the vital importance of training users in all transactions. Key factors for success, according to Diarmuid Quinn of Werum partner ESP are correct product/vendor selection, clear schedules incorporating goals and timelines, communication, management commitment, project team resourcing and empowerment and early definition of the post go-live support model. Real experience of achieving paperless manufacturing on gWAP (the genzyme Waterford Automation Program) was presented by Éamonn Ó Mathúna and Kevin Brady. Perhaps the biggest single challenge, they reported, is actually "Ensuring the paper goes!" Key messages from the day were, first, that operational excellence and lean manufacturing in pharmaceutical production require independent, but integrated MES; second that MES is no longer just a system but a global roll-out manufacturing excellence strategy; and third that the FDA paradigm change to QbD and PAT needs improved process understanding and control, managing the flexible design and control space by powerful product specifications in the MES. Werum argues that within ten years, every pharmaceutical company will operate paperless, with electronic batch recording/EBR systems, so that "the only place in your plant that will still need paper will be the rest room!" Eoin's complete report can be found on the Readout web site at