FR

Online training · Ergonomic batch record (course in French)

Simplify your batch records with a proven method

Goal: 80% right first time at the first review

The only training that gives you a recognised, approved method for simplifying your batch records. Available immediately, at your own pace.

You’re in the right place if…

  • You’re tired of sending batch records back to production for errors or missing data.
  • Review time is too long, and it weighs heavily on release lead time.
  • Your right first time at the first review, at the end of production, doesn’t exceed 15%.
  • You’re preparing to introduce an electronic batch record.

Expected results

30 to 50%less data for operators to enter and for reviewers to check
10 → 70 %right first time at the first review, at the end of production, on average
−20 to −30%review time, at every review level
20+ sitesan approach 100% aligned with regulatory requirements

And records ready to ease the move to an electronic batch record.

The problems found on every site

A structure out of step with the shop floor

Operators go back and forth unnecessarily in the document, and every back-and-forth is a source of omission.

Data that isn’t always useful

Across more than a hundred records analysed, 30 to 55% of the data requested serves no purpose, and each item is a potential source of error.

A lack of ergonomics that leads to error

Data scattered left, right, top and bottom: scattering makes omissions easier.

Vague review rules

Who reviews what isn’t specified, or everyone reviews everything. Review layers pile up, and everyone feels less responsible.

It isn’t inevitable. If batch records have become complex, it isn’t their original design that is to blame, but the history of changes: a CAPA here, a bright idea there. It’s the legacy of several years of drift.

A step-by-step approach, deployed on many sites

The ergonomic batch record method makes it possible to reformat and simplify every type of record, whatever the product and production step, to arrive at a new record template.

  1. Align the batch record steps with shop-floor reality
  2. Remove the 30 to 50% of unnecessary data
  3. Make the record ergonomic, to create filling-in reflexes and reduce errors and omissions
  4. Define guiding principles, to keep records consistent with each other and over time

With this training, you’ll learn to

  • Identify the unnecessary data in your batch record
  • Realign its structure with shop-floor reality, to avoid back-and-forth and omissions
  • Improve its ergonomics to reduce errors, create reflexes and lighten the mental load
  • Make review easier and faster, by making the data checked explicit and consistent
  • Refocus the record on traceability and on everyone’s accountability
  • Define the guiding principles of your ergonomic batch record

What the training includes

Lifetime accessand updates with every improvement
15 lessonsin 7 sections, one per step of the method
1.5 hours of videoin sequences of 4 minutes on average
Exercises at every stepand a running exercise to put the tools into practice
8 ready-to-use toolsto start transforming your records
7 cheat sheetssummarising the key points of the method
1 assessment toolfor data relevance, simple to use
More than 10 templatesof ergonomic batch records to inspire you
Word tutorialsto discover formatting tips
1 online communityto ask your questions

And as a bonus

A right-first-time measurement toolto count the errors detected in review
A roll-out planto assess the workload and track record updates

Online training path to simplify your batch records

Immediate access to the training and the community.

Frequently asked questions

Who is the ergonomic batch record training for?

People who write, update or review batch records in the pharmaceutical industry: production, quality assurance, documentation, electronic batch record projects.

How long does the training take?

The course has 1.5 hours of video, split into sequences of 4 minutes on average, with exercises and a running exercise. You go at your own pace, with lifetime access.

Does the method prepare for the electronic batch record?

Yes. A simplified record, aligned with the shop floor and built on clear guiding principles, is much easier to digitalise.

Can we get support for a whole site?

Yes. The training suits one person or a small team. To transform the batch records of a whole site, we support you directly.