BatchMaster for Life Sciences |
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| In recent years, there has been an increased realization amongst large and medium sized pharmaceutical manufacturers that process ERP systems might be an ideal solution for them because it can address both their information and obligatory regulatory requirement needs. BatchMaster ERP for Pharmaceutical industry is a preconfigured, window based, GAMP category-4, process ERP software specifically developed for process manufacturers who make their products using formula or recipe. It serves as an excellent platform for life sciences and pharmaceuticals industries involved in the manufacture of tablets, syrups, creams, biopharmaceuticals and bulk drugs industries which make their products using formula, and in batches. Key driver behind the design of BatchMaster has been the guiding principles of FDA’s current risk based approach compliance requirements expected of GxP regulated systems (details published in GAMP-4 and GAMP-5) (Please refer to white paper prepared by BatchMaster for more details). Accordingly, BatchMaster Pharmaceutical ERP software has been manufactured based on a complete life cycle approach as part of a quality Management System (QMS), from concept to retirement and scalable approach to achieve and maintain GxP compliance. BatchMaster by its design helps its customers to fulfill most of the cGMP requirements |
BatchMaster for Life Sciences has been successfully validated for its use in pharmaceutical manufacturing industry as per FDA cGMP compliance requirements. It is currently in use by Generic drug and contract manufacturers all over the globe including India, US and Canada. Currently, an FDA requirement accepts validation documents performed in one pharmaceuticals to be used as reference and evidence by other pharmaceutical industry (Please refer to white paper prepared by BatchMaster for more details).
As a result of this provision, documentation load of regulatory compliance will reduce tremendously to new BatchMaster customers. BatchMaster is sold as a complete ERP solution for Pharmaceutical manufacturers and also as integration product package. In integration product package, BatchMaster has been integrated with standard softwares like Microsoft Dynamics, SAGE ACCPAC, SAP Business One etc. Thus, BatchMaster provides a broad range of package options to its customers based on their needs and provide features specific for this sector not offered currently by any other process ERP. |
cGMP compliant features of BatchMaster Life Sciences include: |
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| Complete Formula Management: Comprehensive Formula Management with unlimited intermediate levels, manufacturing instructions, by products, co products and wastes. Enhanced security and approval imposed at Creation, Modification and deletion of formulas. Multiple Packaging and private labeling options available. Anytime formula sizing and unlimited unit-of-measure support for precise control. |
| Lot Management: BatchMaster doesn’t just provide the lot tracking/tracing but complete lot management, starting with creating or viewing lot, moving to managing lots and finally disposing them, whenever required. User-Defined Lot numbers, Lot Attributes/features(can choose from Physical Appearance, QC Values, Physical Property, date or any user-defined value), different Lot picking strategies (like LIFO,FIFO, FEFO, etc), customizable Lot sizes, Lot Issue and restricted based on Expiries, Quarantine, Shelf Life or Close to Expiry etc are few features of our advanced lot management features. Track through the entire supply chain where any Lot was used, to all levels and through all transactions. Lot explosion both forward and backward, down to end-consumer level, to facilitate a full product recall within seconds. Auto-generate Lot-Recall Letters, and export a calling list to MS Excel. |
| Cradle to Death Quality Control: BatchMaster provides the provision of quality checks at pre process QC on raw materials, Production QC on materials in process and post-process QC on finished products as per cGMP requirements. It does not permit the user to include of the unqualified QC products in the system without testing, for its inclusion in inventory, release to manufacture and release as finished product. Moreover, software gives the options of both serial and lot tracking to their customers for any product depending on the need and requirements. |
| Compliance and Reporting: BatchMaster by design permits its users to print and track the reports of cGMP required documents. |
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