AIMES

What an electronic batch record should refuse to do

Scanning paper into a PDF is not an eBR. The value is in what the record will not let you do.

A good record is stubborn

A real electronic batch record enforces the master recipe at the point of work. It will not let step four start before step three is signed. It will not accept a weight outside tolerance without raising a deviation. It will not release a batch while a deviation is still open.

Each of those refusals removes a check that a reviewer would otherwise make by reading every page.

Why this is what makes review by exception possible

Review by exception means QA looks only at what went wrong. That is safe only if the system has already verified everything that went right: sequence, limits, signatures, equipment and material.

If the record is a form that accepts anything typed into it, QA still has to read it all, and nothing has been saved except paper.

How to test one

When you evaluate an eBR, try to break it. Enter a value just outside the limit. Skip a step. Sign with the wrong role. Change a value after signing.

Watch what the system does next: whether it blocks, raises a deviation, asks for a reason, and writes all of it to an audit trail you can read. That tells you more than any feature list.

In short

  • An eBR earns its value through enforcement, not digitisation.
  • Automatic deviations are the foundation of review by exception.
  • Evaluate by trying to do the wrong thing.

See these ideas running on a live line.

Everything we write about comes from plants we’ve worked in. We can show you the same on your process.