CL Electronic Batch Records™ (CL EBR™)
-flexible paperless production
We use Pharma Fast Track for safe and easy implementation. This combined with the latest technology means we solve your problems with individually designed solutions. The effects are not only lean and effective production but a rise in GMP levels.
Compliant Logistics’ Electronic Batch Records (EBR) software replaces today’s paper-based batch documentation with a fully electronic paperless system. This approach allows you to easily adapt to lean production and flexible batch sizes without the burden of creating huge amounts of paper-based documentation.
What we can do for you
One of the major barriers that stop businesses from moving to lean production is the complicated batch record management required by FDA and other regulatory agencies. The CL EBR system easily removes that barrier and opens the way for you to move into lean production. Aside from the immediate positive impact on the bottom line, this move will also increase quality by minimising human error – our system does this by automatically testing data and supporting SOPs, which are maintained inside the system or downloaded from external sources in a controlled manner.
The main functions
Compliant Logistics’ EBR fulfils CFR 21 part 11 requirements. Functionality provided includes:
- Ability to create smaller batch sizes and prepare for automated flow
- Secured identification – eliminates the risk of batch mix-ups
- Integrated quality assurance and control by routing, line clearance, signatures, test results and double-checks
- Automatically produced and stored electronic reports, and
- Production data that allows for continuous improvements and provides full traceability which is extremely useful, for example in the case of recalls.
An Electronic Batch Record is produced automatically at the completion of each production batch and designed to comply with your quality assurance procedures as well as GMP requirements. The software is designed to fulfil applicable GMP requirements such as FDA CFR 21 part 210, 211, 820 (QSR), 11 (ER/ES) and European directives 93/42/EEC (MDD), developed according to GAMP guidelines. Each customer application is qualified (IQ/OQ).
The differences that make the difference
The uniqueness of our EBR software is its seamless and effective integration with our production logistics software, CL Pharmasuite.
CL Pharmasuite gives you a highly effective software platform which manages and controls your production logistics, working with the production flow and tracking key performance indicators in real time. This together with the paperless production support provided by our CL EBR system gives you a competitive edge.
The flexibility of our approach combined with the latest technology means that we can solve your real problems with an individually designed solution. The effects of this are not only a more effective production but also a rise in GMP levels.
The results
The immediate result is the possibility to move to lean manufacturing and cut costs substantially. You get real time data access, with smooth integration into your ERP. An increase in the quality of your products through minimising of human error is also a consequence of the move to EBR, and in removing the barrier of complicated paper documentation, your quality assurance staff will be able to work more proactively in supporting production and not waste efforts correcting physical batch report errors.
Download CL EBRTM, PDF Document, 579 kB