HBT Labs, Inc. is a technology-based specialty pharmaceutical company focused on the development and commercialization of “High Barrier Therapeutic” injectable drugs. HBT Labs has a full array of expertise, including advanced scientific research in the areas of drug delivery systems, process development, patent analysis, and regulatory compliance.
HBT Labs contacted BatchMaster when it had determined that its then-current business software could not support the future demand for its services and stringent regulatory mandates. The company needed a new business software that would streamline and scale up its operations, as well as provide a real-time, 360 degree view of its business KPI’s.
Recognizing that while new business software would offer new functional capabilities, it would also require validation consistent with regulatory requirements and best practices. HBT Labs needed assistance to help validate its business operations and new business software during its implementation and prior to use for production.
HBT Labs partnered with BatchMaster Software due to the company’s focus on process manufacturing solutions, including life sciences, and its end to end ERP solution, which offers life sciences manufacturing capabilities in addition to sales, purchasing, financials, distribution, and customer services all in a single unified application.
GMP Validation Center (GMPVC) was hired by HBT Labs to assist the company in validating its processes using BatchMaster ERP. This software validation agency had the regulatory expertise, an understanding of BatchMaster ERP and SAP Business One applications, and a tool kit offering prebuilt templates that would streamline the validation process.
HBT Labs decided to initiate both the implementation of the ERP software and the validation process, simultaneously, consistent with regulatory requirements.
Throughout the implementation, the GMPVC team helped keep all project teams in line with GMP validation guidelines. In the Planning phase, as the GMPVC team prepared test scripts and documents as required by GAMP 5 guidelines, the team suggested improvements to HBT Labs current processesand assisted with interpretations of regulatory guidelines as applied to HBT’s processes and the BatchMaster ERP system.
In light of the COVID-19 pandemic and related shutdowns and restrictions on in-person meetings, BatchMaster Software and the GMPVC team followed a remote implementation strategy that successfully implemented the ERP application and completed the validation process.
As a result of the validation effort, a reusable test script library as well as dedicated test server, the replica of BatchMaster ERP’s production environment, has been created for testing of future enhancements and releases before deployment into the production environment. Standard regulatory practices for business continuity, including Disaster Recovery and Backup-Restoration, of the cloud environment are managed by BatchMaster Software.
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