Hart Biologicals Limited

Case Study

Hart Biologicals Limited are based in Hartlepool and began using OrderWise in 2007

They research, develop, manufacture and market a range of ‘in-vitro’ diagnostic products for use in the detection and monitoring of a number of medical conditions related to haemostasis and platelet function.

With customers ranging from hospitals, GP’s, Health Centres and distributors, they produce over 100 product lines along with contract ordered items manufactured to customers’ requirements.

They stock various chemicals and packaging for the manufacture of haemostasis and platelet function testing kits, completed testing and Reagent kits, control plasma plus testing equipment and consumables.


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.


The Requirement

Hart Biologicals were previously using QuickBooks for their accounts, managing their stock via spread sheets and Bill of Materials via written procedures which were manually recorded. Mal Pattison, Operations Manager told us:

“The paper trail was becoming unmanageable, efficiency was poor and traceability was being compromised. As product ranges increased, customer base and contract manufacturing expanded we began to find that the manual system was unsustainable.”

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.

They needed a system that could give them full traceability, manage Bill of Materials and simplify the complex processes and procedures in the manufacturing of test kits. They also wanted a system which could be used throughout the business and integrate information from all departments.

“OrderWise has improved the management of stock levels and contract production to ensure maximum possible shelf life is maintained. Many of our contract products have a 12 month shelf life and require a minimum of 11 months at the time of receipt by the customer. Batch traceability means we can control this and also enables any product falling below 6 months to be provided to customers with a fast turnover thus minimising wastage.”

Why They Chose OrderWise

It ensures full product, component and batch traceability at all levels, from raw materials to finished products and provides a full audit trail of each component within each batch back down the supply chain.

Accurate and effective planning of production and forecasting ensures correct stock levels of raw materials are held meaning production is completed on time to meet customer requirements.

Chemicals and components are bought in from around the world with varying lead times and OrderWise enables them to take account of these factors when planning production.

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.

“There are also import document required for each country along with certain regulatory requirements dependent on the country. The Reports and Layouts Team helped us ensure FDA codes were included on products shipped to the USA.”

Hart Biologicals future plans include a changeover to Sage 50 Accounts and they are looking forward to the integration that OrderWise will provide.

Thank you to Mal Pattison and the staff at Hart Biologicals for talking to us about OrderWise and showing us around their laboratories.

visit the hart biologicals website

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