POMS CMS is a manufacturing execution system specialized for support of manufacturing of clinical supplies. POMS CMS directs and enforces current Good Manufacturing Practices (cGMP) and streamlines production, packaging, labeling, and distribution of clinical supplies. Your company, manufacturing clinical supplies under control of POMS CMS would have records of physical process activities and an ongoing log ensuring all activities were performed in a compliant manner.
Since all process records under POMS control are electronic, the software also simplifies the transfer of formulation histories and master batch records to commercial production. The result is faster new drug application (NDA) preparation and new product scale-up.
POMS CMS provides you compliant materials management, quality management, weigh/dispense, recipe specification and execution and shipping management. In addition, for the clinical environment, there is direct support for clinical operational entities included in study management, request management, detailed primary and secondary packaging and labeling support, with all functions organized around a single database and business model, allowing the business user, manager and QA reviewer to plan, perform, track and audit in a homogeneous paperless environment.
POMS CMS may be implemented as a stand-alone system but has often been integrated with many other specialized software and hardware systems to form the basis for a collaborative manufacturing system. The POMS product has been interfaced to software packages such as LIMS, ERP, Planning, Scheduling and Reporting. POMS has standard interfaces to process control systems and such standard manufacturing hardware as scales, scanners and printers.
POMS Trakker, an add-on product to POMS CMS product suite, is a software application running on a wireless hand-held Pocket PC. The Trakker workstation and software provide mobile materials management functionality for manufacturing and process operators who can’t be tied to a desk or workstation. The wireless workstation can be installed and used with relatively few changes in existing facilities. As a POMS workstation, the Trakker is fully integrated with the POMS database and security system, providing the same real-time information and update capabilities as standard workstations. Trakker utilizes .NET technologies to provide real-time inventory information, and Trakker is designed and implemented to be compliant with 21 CFR Part 11 regulations regarding user authentication and authorization.