Pharmaceutical Electronic Batch Manufacture Recording (eBMR) Software
For pharmaceutical companies, accountability is an important component of quality management and FDA compliance. Electronic batch records systems, required by FDA Current Good Manufacturing Practice (CGMP) regulations, demonstrate accountability by providing proof of proper handling for every step in the production of each batch of a drug product. In addition, manufacturers that execute and document batch records electronically must comply with 21 CFR Part 11 requirements.
Batch operations conducted manually are inherently slow, cumbersome, and error prone. As regulations get more complicated, EBR systems become exponentially larger and more complex, taking more time to prepare and review. Common snags to manual batch operations include: incorrect data entry, failure to recognize out-of-specification entries, missing signatures, filling out incorrect forms, sending forms to the wrong recipient, and forms left incomplete.
We propose step wise approach to achieve the fully automated EBMR. To start with Organizations can start the Batch record Issuance Process, once after seen the success start the batch process recoding online, after successful implementation of Batch Online Recording integrate the same with equipment’s to auto record data from equipment’s
PharmaMax Process is the ideal platform for automating and optimizing management of batch records.
- Complete Data Capture: All user entries are captured, electronically stored, and available for reporting in the EBR software. This includes loading of external files, making them part of the batch record.
- Data Integrity Checks: Each field can run automatic checks to ensure that the data entered is in the correct format. Missing data, incorrect date formats or incorrect units of measure will never be a problem with PharmaMax's EBR software.
- 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. Never worry about accuracy of calculations again.
- Performer/Witness Signoff: Each signature point can be configured for a single signature or Performer/Witness signatures within an electronic batch record systems. Performer/Witness signature points allow two users to submit their signatures from a single signoff window.
- Parallel and Sequential Processing: Processing steps can be set up in a combination of sequential and parallel units.
- Integrates with Deviations: Every manufacturing process needs a mechanism to deviate from the prescribed procedure, but controls must be in place to ensure that a deviation is acceptable. PharmaMax's electronic batch records software seamlessly integrates the recording, assessment, and approval of a planned or unplanned deviation into the overall manufacturing process. PharmaMax's EBR and Deviations solutions also link to other quality management modules such as PharmaMax Nonconformance and PharmaMax CAPA.
- Analytics Reporting Tool: This built-in tool of an electronic batch records system comes with a standard set of pre-configured reports that can be customized by the user. Production records can be trended and analyzed by product, recipe, process stage, etc. These data-mining capabilities provide important insights into overall production activities such as turnaround, quality issue rates, etc.
- Compliant System: As with all EBR software developed by PharmaMax, 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.
- Unparalleled Validation: PharmaMax considers validation an integral part of solutions for FDA-regulated customers. PharmaMax's revolutionary approach to validation dramatically cuts the time, effort, and cost of validation, making it easier to validate future upgrades.