Medical Device companies are required to track and maintain historical records of every batch of products it manufactures. Electronic batch records provide a comprehensive audit trail of the manufacturing process and conditions for each unit or batch produced. Electronic batch records can simplify and automate the process of recording, reviewing, approving, and filing historical records, inherently providing an audit trail. The QUMAS solution for electronic batch records provides an advanced, efficient, and fully 21 CFR Part 11 compliant system which improves accuracy, speed, and reduces costs. Records are instantly retrievable online via a web browser for authorized users, and for supporting the audit process when required. Management reports can be generated from the metadata information captured in the records in the system.
Organizations who do their own manufacturing know that the primary bottleneck in releasing a batch to market is the time and effort required to build the master batch record (MBR) after the processing steps have been completed. The goal for manufacturing divisions is to minimize the manual steps that slow down the process and also affect the accuracy and completeness of the information.
By utilizing the automated QUMAS Electronic Batch Record solution manufacturing divisions can benefit from:
- Reduced cycle time
- Reduced inventory
- Reduced data entry errors
- Improved visibility of production and process exceptions
- Rapid return on investment
Please contact us directly for more information or a demonstration of this solution: firstname.lastname@example.org