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. There are many disadvantages to this approach of managing batch records:

  • 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.

MAXLife 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.

Benefits of the MAXLife Electronic Batch Records (EBRs) include:

  • 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!

View our blog article: The Top 7 Benefits of Electronic Batch Records.

MAXLife makes it easier for Life Sciences companies to access and track batch records, model and change complex processes, and speed time-to-market. It can dramatically improve profitability, productivity, and product safety at even the most complex organizations.