Weigh and dispense provides the backbone of the manufacturing operation and ultimately the starting point of the batch record. The weigh and dispense module of Werum's PAS-X MES solution is an innovative replacement for the mechanical and manual methods used in the weigh areas of many pharmaceutical companies.
Accurate data collection in weighing and dispensing is fundamental to batch tracking and documentation. The weigh and dispense module securely guides the operator through all weighing instructions and provides the necessary support to comply with safety regulations and recipes. It controls weighing operation including manual and automated weighing, dispensing and filling processes and thus increases the quality of the weighing process.
Each event is logged and each action is stored with the user name, time/date stamp, location and workstation used. Manual data entered by operators can be verified against expected ranges to ensure accuracy or identify deviations. Documents and data are archived in accordance with GxP/FDA regulations for electronic records and electronic signatures (21 CFR Part 11 compliant). Audit trails are also supported.