Extra efficient E-batch records

Situation

SGS DNA Köping produces large biomolecules for customers in the Life Science sector. It’s a complex production process with many teams involved, data scattered in locally developed systems, and paper-based batch records manually signed multiple times.

Batch review and approval is a work-intensive process involving the QA team. A paper-based Certificate of Analysis is produced as a result of the release process.

Batch documentation and release needed improving without risking product quality.

Challenge

Improve the batch documentation process in order to:

  1. Give all teams an overview of the customer order
  2. Support/lead operators through the production process
  3. Eliminate mistakes and transcription errors, thereby, minimizing the need to check data
  4. Give teams easy access to each other’s data to simplify decision making during the process
  5. Gain a better overview of batch data for QA
  6. Allow automated data transfer from instruments
  7. Shorten production lead time

Solution

PlantVision and SGS DNA worked in close partnership to implement a new Electronic Batch Records solution based on SampleManager®.

An extension was added to SampleManager to provide a tool for registering customer orders.
Workflows and templates in SampleManager were configured to reflect SGS DNA’s production chain and documentation needs, as well as the Certificate of Analysis.

SampleManager standard functionality was used to provide a platform for label printing, instrument and stock handling and future integrations to other systems and instruments.

Results

  • Standardized way of documenting – Same structure for all products and validated calculations, minimizing the need for checking.
  • Increased efficiency – Less time spent filling in and copying paper documents. Several users can view the same data simultaneously.
  • Data security – System controls which personnel are allowed to access or edit the data. Backups easily carried out by IT.
  • Data overview for QA – Faster review and approval process.

“We are pleased with the customized LIMS system and the support from PlantVision both during development project and drift phase. PlantVison has supported our project with skillful and engaged specialists.”

Bernadeta Losy, QA Manager, SGS DNA, Köping