INTRODUCTION
Xseer Pharmaceuticals is a California-based 503B outsourcing business that produces nonpatient-specific batched pharmaceuticals. Its product line includes mainly nutraceuticals, such as vitamin supplements. Xseer falls under USP, GMP, and US Pharmacopeia guidelines for pharmaceutical manufacturing.
Xseer Pharmaceuticals is a family-run business of health professionals, from its CEO to its technicians. All have been in the healthcare field and serving patients in their communities for many years. Patient safety is the company’s top priority.
CHALLENGE
Xseer was starting to validate its nutraceutical products and wanted to bring in software that could help it grow. The business used QuickBooks for financials, but most other operations used a paper-based system. Then, they developed an in-house system that helped smooth operations, but couldn’t provide the batch record documentation and workflow needed. Harvey Bharaj, Quality Assurance Manager, explains, “We wanted to improve efficiency and material traceability for better inventory control from the start, including any materials used for testing, to the end of the process.”
Xseer Pharmaceuticals required electronic signatures to meet compliance requirements, but it did not have that capability. They struggled with material handling and the manufacturing process as a whole. They needed to digitize their processes in their ISO-classified clean rooms and ensure their aseptic technique could keep the cleanliness of their clean rooms as required by regulations.
SELECTION
Xseer Pharmaceuticals was happy with QuickBooks for its financials, so it began looking for software to integrate with it and handle its operational needs. The company explored several solutions that covered two or three of its ERP, quality management, and electronic batch record system needs. They looked at Oracle-based software, a Master Control system, and BatchMaster’s QuickBooks Edition and considered developing something internally.
“I understand the complexities of data integrity and the world of computer systems validation, and I also understand the regulations and requirements around that,” stated Bharaj. “So, anything that wasn’t compliant was immediately ruled off our list for software.”
They wanted a system that could work with them at the ground level and help them grow. They selected BatchMaster for its out-of-the-box solution features and customizable options, which they look forward to working into their systems. BatchMaster could also integrate with QuickBooks, which was critical for them. The software needed to fit their financial constraints as a startup, which BatchMaster did. The onsite visit by BatchMaster’s team and the demo showing its industry-specific functionality helped them pull the trigger.
OPERATIONS
Xseer Pharmaceuticals looks forward to having its material flow managed from the moment it enters to the moment it leaves the building. It plans to use BatchMaster’s barcode scanning capabilities throughout the facility to ensure all materials are barcode-traced.
“We need to ensure we have full traceability of all our materials, including our raw materials and any components, as well as intermediaries and finished goods from start to finish,” explained Bharaj.
Xseer intends to use BatchMaster’s Manufacturing Execution System to streamline production and its Warehouse Management System to increase efficiencies. They will also use BatchMaster’s Planning and Scheduling capabilities to refine and expand their product line. Currently, they handle their production scheduling using Excel spreadsheets. BatchMaster will allow them to develop their product portfolio by effectively managing Xseer Pharmaceuticals’ supply and demand.
NEXT STEPS
Xseer Pharmaceuticals is just beginning the implementation process and is excited to eliminate its paper-based system and embrace software that allows for digital signatures and electronic batch records. Once BatchMaster ERP QuickBooks Edition is up and running, they look forward to streamlining operations and tracing materials through manufacturing. They will also be undergoing FDA and GMP validation. With BatchMaster, Xseer will be able to increase efficiencies, expand its product line, and grow the business nationally.
