Moving to electronic batch records: start with one operation

Ask people to walk through the work

Bring together the people who perform the operation and those who review its records. Use the existing batch record as a starting point. Ask what triggers the work, what the operator checks and how they know they can continue. An instruction that seems clear to an experienced operator may leave considerable room for interpretation.

Then follow an interruption: an unreadable container label, unavailable data or an operation already under way. Establish what is retained, who gets involved and the point from which work resumes. These answers directly inform the MES recipe design.

Trace each piece of data to its source

Building that master record requires a definition of the data needed and how it will be used.

For each item, identify its source, its owner and when it must be available. An operator entry, master data and an equipment result involve different exchanges. Specify the unit, the batch context and the expected behaviour if the information is missing.

Vendor source: Siemens · Opcenter Execution Pharma

Review the future record before building every screen

At the end of the workshop, describe the operation from the reviewer’s perspective. Can they identify what was performed, find the checks and understand how an interruption was handled? This exercise sometimes reveals information that nobody had planned to capture at the workstation.

An initial scope can be limited to one operation, provided its dependencies are examined. Record the agreed decisions and open points, with an owner for each. If an interface is temporarily replaced by manual entry, state what must change to reach the intended production setup.

This work provides a practical basis for design and testing. Acceptance criteria and validation activities are developed alongside these decisions, within the project framework and the site’s quality system.