When an existing manufacturing company decides to update their ERP system, there are certain things which are already well established, and which can be brought into the new system. Chief amongst these is the entire Costing Structure.
For a brand new start-up enterprise, that is not available. Of course, there is a theoretical cost structure upon which the business was established. All manufacturers know that the nuances and quirks of manufacturing can impact those cost models considerably. It falls to the Controller of such a start-up to monitor, manage & control those costs so the business tracks as close as possible to the original theoretical model.
STAQ Pharma, is a Denver, Colorado based, brand new 503B outsourcing facility involved in compounding sterile injectable medications, producing up to 30,000 syringes per day.
Responsibility for matching the reality with the theoretical costs for STAQ fell to Controller Shane Sekiya. Said Shane “We are a new business that did not have any product based ERP system. There are multiple raw material inventory items required in order for us to produce our products. Once production becomes automated and high volume, spreadsheets will not be efficient nor effective in tracking raw materials inventory nor finished goods inventory.”
Of course, the control of inventory movements and costs for an operation like STAQ Pharma is only one aspect. Shane went on “The FDA also requires our industry to be able to document, qualify, verify, and trace all transactions and products.”
Shane’s search for the right system brought him to BatchMaster. Shane told us “It’s an industry standard, and it’s easy to use. BM also has the ability to be qualified, which for a cGMP plant like ours is critical. Visibility of data is great, and the Reporting capabilities are extensive.”
Shane expects to see quick and clear visibility in his perpetual inventory counts. He is looking forward to trend reports in purchasing, production, costs, and other activities to help save him time in inventory management. Shane expanded “Visibility, organization, tracking, and tracing are the expectations. We must know at all times what we have on hand, what was used, how much was used, how much it cost, where these items came from, and where they went. This is tracked by product type and/or lot#s.”
The FDA introduced new regulations where Pharmaceutical outsourcing facilities like STAQ, which compound, manufacture, and sell medications in large batches to healthcare facilities, were required to be, or become, a 503B. STAQ Pharma is proud to be one of the very first facilities built as a 503B from the ground up.
BatchMaster Software is delighted to have STAQ Pharma as part of our family of customers, and wish them all the best as we work together to build their new system.