Digital transformation efforts are accelerating in a variety of manufacturing areas, yet many producers stop short of digitizing their device history records (DHRs) and other shop floor data collection efforts. Despite the investments manufacturers have made in tried-and-true digitization and automation – including enterprise resource planning (ERP), manufacturing execution systems (MES), material requirements planning (MRP), laboratory information management systems (LIMS) and supervisory control and data acquisition (SCADA) – the investments are too often impeded by critical processes that remain manually collected, disconnected and often paper-based activities. The people on the production line have been left to deal with paper.
At every step, manual, paper-based processes are slow, cumbersome and prone to error. When manufacturers employ such systems to manage their data collection and DHRs, human errors and poor data integrity have a cascading effect as the data advances through the production process, slowing everything down. As a result, companies using paper-based processes often see the same problems repeat throughout the production life cycle: inefficient processes, inaccurate information, disconnected systems, poor visibility and preventable quality issues.
A digital DHR solution can extend manufacturers’ ERP and MES investment to the shop floor, eliminate production data input/integrity issues and overcome paper-based GMP review and release barriers. By digitizing and automating their DHRs, life sciences organizations can capture a holistic view of the manufacturing data and insights needed to optimize production, reduce deviations, and corrective and preventive actions (CAPAs), improve right-first-time (RFT) metrics and accelerate product release – closing the digital gap and delivering significant productivity and quality improvements.
Manufacturers’ heavy investment in ERP and MES is often impeded by critical processes such as execution and review of DHRs, or production records, that remain manual, disconnected and often paper-based activities. Digitizing DHRs enables medtech manufacturers to extend digitization to the users who need it most on the shop floor.