Electronic Batch Records
Many Life Sciences manufacturers today rely on paper-based and people-intensive processes to document every step in the production process of a batch to comply with GMP and other compliance standards. Electronic Batch Records addresses many disadvantages to this approach:
- Paper-based processes increase operating costs, risk, and the possibility of human errors.
- Manual batch operations are inefficient, time-consuming, and slow time to market.
- Physically managing batch records is complex and provides limited tracking and visibility in the event of any non-conformances.
AKA provides Electronic Batch Record (EBR) capabilities that reduce manual processing and operating costs by tracking Batch Records electronically, having them go through a life cycle of approvals, security, and workflows along the way.
- Complete document lifecycle management capabilities, including automated workflows, audit trails, and full versioning support.
- Reduces time, effort, and costs associated with manual and paper-based processes.
- Enables compliance with industry and government regulations (including FDA 21 CFR Part 11).
- Increases traceability and enforces document / data security.
- Integrated quality control and product safety document management solution for Recalls, CAPA, SOPs, Audits, Complaints, GMPs and more!
AKA will help you to eliminate costly paperwork errors, speeds up information distribution and collaboration, and enables strategies for improving quality and efficiency and make it easier to access and track batch records, model and change complex processes, and speed time-to-market.