Short and Long-Term Strategies

Before making the transition from paper-based to EBR/MES, it is important to determine the impact the deployment will have on the internal processes and organization.

A review and assessment of the current and future state can help develop short and long-term strategies for deploying EBR/MES.

• Current and future equipment/production line capabilities
• Existing executed Batch Records and all batch documentation during lot processing, e.g. forms, reports, labels, and log books
• Workflow of batch documentation execution, i.e. does the documentation workflow follow the production workflow
• Handling of samples, in-process quality checks, AQLs, and data trending
• Opportunities for automated data collection and monitoring
• What processes and data can be captured electronically or should remain paper-based
• Current and future system interfaces
• SOPs that may need to be created and modified to support deployment

What processes will be impacted, who is responsible for each process and the data collected, and how will the changes be managed?

The review and assessment can also help determine which approach works best for your organization:

• Process approach – convert one operational process at a time
• Product approach – a product that is a one-ff or does not affect other product lines that can be the beta
• Product Family approach – same type of product manufactured and packaged on similar equipment