HBT Labs, Inc. selected BatchMaster ERP for Pharmaceuticals to manage the development and commercialization of their “High Barrier Therapeutic” injectable drugs. BatchMaster ERP is an end to end ERP solution, based upon the SAP Business One platform, that supports financials, sales, purchasing, supply chain and customer service, in addition to pharmaceutical manufacturing.
HBT Labs develops and produces injectable pharmaceuticals with a focus on emulsions, nano-emulsions, liposomes, lipid-based drug delivery systems, and suspensions. As a 5-year old pharmaceutical company, management recognized that the company was quickly transitioning from a focus on research and development to an environment that would include significant commercial manufacturing activity. Greater collaboration between the purchasing and accounting departments was needed. It became obvious that the company would reap numerous benefits and efficiencies with a transition from a “paper-based” system to a fully-integrated ERP system capable of meeting the high quality and validation requirements necessary in the pharmaceutical manufacturing environment.
HBT Labs engaged an outside consultant to lead their ERP selection process. Many ERP systems were eliminated because they were not properly set-up for facilitating FDA validation. “We chose Batchmaster ERP for its demonstrated cGMP functionality in a pharmaceutical manufacturing environment, for the ability to validate this system with confidence and for the highest level of attention to our needs and concerns demonstrated by the BatchMaster team during the process”, stated Janet Braun, COO and General Counsel of HBT Labs.
BatchMaster Software offers a set of validation templates in its FDA Validation Toolkit which satisfies FDA Guidance and ISPE GAMP® 5 best practices. Each template contains a series of transactional steps or screens used in configuration, execution and reporting. Armed with these templates, HBT Labs can reduce the time, effort, risks and costs required to document their processes, allowing the team to focus on the data used in executing these processes.
Janet is confident that with BatchMaster ERP “we will be able to increase the overall efficiencies of our operations to help transform and quickly grow our business”