In the Life Sciences Industry, Batch Record provides proof that an organization properly handles and records all critical steps to produce each batch of a product. Currently, the recording is done in manual Batch manufacturing records in the GMP Environments
You can know more about electronic batch record at https://factory-talk.com/it-solutions/electronic-batch-record-ebr.
The organization need to keep a check on the following areas in order to avoid data integrity issues
- Issuance of Batch Records and reconciliation
- Employee training records on their qualifications
- Verification of Logbook data against the Batch records information
- Employee in and out timings
These manual checks are tedious as the number of batches manufactured in Formulations units range from 20 to 200 batches per day and in API’s the numbers are higher.
Implementing an electronic batch record system (eBMR) helps organizations to improve data integrity and accuracy. It can streamline processes and increase operational efficiency which positively impacts the bottom line.
AmpleLogic eBMR is a typical manufacturing Execution system (MES), designed to meet the needs of the Pharmaceutical and Biotechnology Industry. Our Electronic Batch Recording Software helps in recording the detailed manufacturing steps specific to the product. It also optimizes your processes through the introduction of electronic work instructions, process checkpoints, mapping process activities, and effective exception handling.
The EBR software delivers paperless manufacturing by replacing paper batch records, batch approval, and release process through an online environment.
AmpleLogic Electronic Batch Record System is built on LOW CODE PLATFORM with a modular design that facilitates the breaking down of the entire pharmaceutical manufacturing process into small components. Users can drag and drop processes (like granulation, compression, coating, packaging, etc.) and select process-specific activities(like Punch Specifications, Milling, Sieving, Average mass of coating, De Blistering, etc) that shall be carried out for every batch to be executed.