The In-Process Quality Control automates all quality check processes. It helps drug manufacturers reduce effort, time, cost and clutter by providing various test reports in a concise manner for a batch.
The IPQC module of CaliberBRM contains test protocol with several test patterns with defined acceptance criteria, limits, groups, etc. The quantitative tests like weight, hardness, thickness, etc. and qualitative tests like visibility, etc. are performed as per test protocol.
Based on the initial instructions provided, In-Process Quality Control automatically defines the sample pattern that must be generated in the test pattern. This helps avoid duplication of tasks.
Based on configuration given in a test protocol, the sample withdrawal alert will be scheduled to withdraw sample. These tests are triggered based on the frequency, department (QA, production, etc.) and test protocols. Moreover, the sample withdrawal schedule is completely configurable based on client requirements.
For every equipment, IPQC module generates and triggers calibration schedules automatically based on the set frequency (daily, monthly, quarterly, yearly). CaliberBRM triggers the alerts to the relevant group based on the pre-determined workflow. Further, it triggers unscheduled calibration between scheduled calibration in case of equipment failure/maintenance and revival. It also facilitates drug manufacturers to generate and check positional variance, perform spirit level test, etc.
The In-Process Quality Control Module triggers alerts as soon as technical issues arise during an operational transaction of an equipment/ instrument. It also triggers service alerts. All the users are intimated with problem reporting/ service reporting status alerts. Further, the system doesn’t reflect the equipment/instrument in the mapped equipment list. Thus, facilitating in timely action and issue resolution.
Different types of reports can be configured in CaliberBRM – yield report, batch protocol report, stage closure reports, complete batch reports, sample quantity report, raw data report, individual equipment report, all equipment report, equipment usage report, and many others.
The IPQC module enables the users to change the placement of fields in the reports. This unique feature eases the burden of users.
The range and limits of yields are configurable on the drug manufacturer’s requirement. This application also provides yield reports for every stage of the batch.