What is an electronic batch record? Contents, release and moving off paper

What a batch record is

After every batch you need to be able to show how it was made. A customer asks after a complaint, an auditor during a visit, and quality needs it to release the batch. That evidence is the batch record, also called the batch manufacturing record.

In many companies it is a binder: a printed production order, completed checklists, weighing slips, material labels and signatures. An electronic batch record captures the same information digitally, at the moment the work happens, linked to the order, the line and the lots.

It helps to keep two terms apart. The master batch record describes how a product should be made. The batch record captures how one specific batch was actually made.

What belongs in a batch record?

What exactly is required depends on your sector, your certification and your customers. These parts almost always appear:

• Product, batch number, order and the recipe or instruction version used
• Materials and packaging with lot number, the quantity weighed or consumed and who did it
• The steps carried out with time, line or machine and operator
• In-process checks with measured value, specification and result
• Deviations, with cause, action taken and who approved it
• The yield: how much was made, how much was rejected and why
• Signatures of operator, supervisor and quality, and the release decision

Paper or electronic: what is the difference?

A paper record is filled in during production and only checked afterwards. A missing signature, an illegible lot number or a value out of specification only comes to light when quality leafs through the binder. Then someone has to go back to the floor, and the batch waits.

An electronic record checks during the work. A mandatory step cannot be skipped, a wrong lot is stopped at the scan and a value out of specification is flagged at once. Times, lot numbers and counts come from the system instead of a pen.

The main differences at a glance:

• Complete: empty fields and missing signatures show up at once, not afterwards
• Searchable: you find a lot or batch without going through a filing cabinet
• Reliable: every change is recorded with who, when and why (the audit trail)
• Connected: the same lot links the record to stock and to the customer who received the batch

How batch release changes

With paper, quality reads every record page by page: are all signatures there, do the lots match, are the values within specification? That takes time per batch, and meanwhile the batch sits in quarantine.

With an electronic record most of that checking is already done during production. Quality mainly reviews what deviates: open deviations, values out of specification, changed data. This is known as review by exception.

An example: batch 88213-A is finished at two o'clock. All 14 checks passed, the four lots and their certificates match and no deviations are open. Quality opens the record, sees nothing out of line and releases the batch with an electronic signature.

What to look for when you switch

An electronic batch record stands or falls with how it is used on the floor. A few questions up front:

• Can operators fill it in at the line, on a tablet or screen, without double work?
• Do lots, times and counts come in by themselves, or does someone still retype them?
• Does every user have their own login, so a signature really belongs to one person?
• Are instructions and checks version controlled, and can you see which version applied to a batch?
• Can you export a complete record per batch for an audit or a customer?
• Do you work under GMP or other regulation? Then include validation and the requirements for electronic signatures in your choice.

Where Frontlink fits

In Frontlink the batch record builds itself from what happens on the floor. Operators scan materials, checks appear as a checklist with the specification on the tablet and deviations are recorded with photo, cause and action. Lots, checks, downtime and signatures come together in one record per batch.

Quality reviews and releases, and the certificate is in the customer portal. A Frontlink engineer builds it at your site, on your own data and ERP. You start with one process, which is usually running within a few weeks.