Hart Biologicals Limited

Hart Biologicals Top Five Features

• Batch recording to provide full traceability essential to meet regulatory requirements.
• Provides quarantine procedures within the system to allow for effective handling of products or components which require further testing, or have not met required standards to ensure these cannot be used, sold or included in free stock until a final decision has been made. If defective components are used then large write offs have to made of the finished product.
• Enabled allocation of specific batches to individual customers and are able to provide a higher level of service to customers. E.g. Testing machines have to be calibrated to the specific batch of Reagent, by allocating a batch to a customer this means they can reduce the number of times they need to re calibrate machines.
• Ability to deal with sales for both manufactured products, contract production and standard off the shelf products. Can provide across the board service to all customers with fast reaction to urgent and last minute kit requirements.
• Separate price lists for customers as some work off list prices whilst others have specific rates negotiated.

It is essential that Hart Biologicals can provide full end to end traceability of every component, sub-assembly and batch to conform to their ISO 13485 requirements. Their existing system was unable to allocate batches to orders or customers. They were also finding it difficult to plan production effectively and ensure component stock levels were correct.

Complex Bill of Materials can now be easily managed and changes made with ease in case of specific requirements, e.g. different packaging/volumes. Important test documentation and certification can easily be linked to each batch.

The software has also helped improve purchase planning and monitoring. They can easily use multiple suppliers for the same product to ensure stock arrives on time and at the best price whilst retaining audit history and managing supplier part numbers.