Master Control EBR is focused on the documentation used for production. The software tracks all routing information and data entered into their electronic form. Operators use the form to follow the overall process and to understand the sequence of events during processing. The system can handle a mix of parallel and sequential processing steps or unit procedures under the same recipe. Deviations can link to other MasterControl quality management modules such as MasterControl Nonconformance and MasterControl CAPA.
- Complete Data Capture: All user entries are captured, electronically stored, and available for reporting in the EBR software.
- Data Integrity Checks: Each field can run automatic checks to ensure that the data entered is in the correct format.
- Automated Calculations: Calculation logic ensures that each data item only has to be entered once and can feed into calculations such as yield calculations or recipe amount calculations.
- Performer/Witness Signoff: Each signature point can be configured for a single signature or Performer/Witness signatures within an electronic batch record systems.
- Parallel and Sequential Processing: Processing steps can be set up in a combination of sequential and parallel units.
- Integrates with Deviations: Integrates the recording, assessment, and approval of a planned or unplanned deviation into the overall manufacturing process.
- Analytics Reporting Tool: Has a standard set of pre-configured reports that can be customized by the user.
- Compliant System: As with all EBR software developed by MasterControl, the solution is fully compliant with 21 CFR Part 11 regulations, providing time-stamped audit trails, reporting, and electronic signature capabilities. Security features include dual passwords for document approval as well as password expiration, encryption, and certification.
MasterControl is 21 CFR Part 11 compliant. The system is limited because it only functions to captures data in the Master Recipes (the documents that outline the details of a manufacturing process) and the Control Recipes (authorized copies of the currently effective Master Recipe). It will be most useful to companies who have already adopted other MasterControl modules or only want to use the very limited functionality offered by this system.
We invite you to leave a comment or a review of this system especially if you are a current user of the system. We appreciate your feedback and we expect it will help other potential users to make a good choice when they decide to use electronic batch records in their manufacturing operation.