BatchMaster ERP - Process Manufacturing Software - Regulatory Compliance
Module
Compliance support in BatchMaster ERP is as comprehensive as the range of regulations process manufacturers are required to meet. Throughout the system, the commitment to meeting regulatory compliance is pervasive and all-encompassing. Specific areas of interest are:
Pervasive Compliance: The number one determinant in software development at BatchMaster is Regulatory Compliance, and every new feature and function is tested against compliance standards and requirements while trying to maintain maximum flexibility for those whose compliance needs are fewer. Every effort is made to ensure compliance with FDA’s 21 CFR Part 11 and cGMP standards, including electronic signatures and audit trails. Warehouse and Shipper information fully complies with the Bio-Terrorism Act.
MSDS & SARA: The MSDS/Compliance module has powerful features that will automatically generate Material Safety Data Sheets in full compliance with the OSHA Hazard Communication Standard, SARA Title III, ANSI, and virtually all similar government reporting requirements. This module is designed to accommodate any required changes to meet new regulations immediately, without the need for a program update.
The output MSDS is created as a Microsoft Word document. New MSDS and Labels generated automatically upon Formula change, based on Customer History, Finished Goods, Formulas, Sales Orders or Raw Materials. MSDS/Compliance documents will read calculated Laboratory values as well as Quality Control specifications and results.
"SARA" (Superfund Amendment and Reauthorization Act) processing for year-end or other defined periods.
HACCP (Hazard Analysis and Critical Control Point) is a production control system designed originally for the food industry but now becoming widely used over many process manufacturing sectors where even the Coatings industry is becoming concerned with bacterial contamination of paints and other coatings. It is a process designed to prevent rather than catch potential hazards and BatchMaster ERP has implemented an HACCP module across all functions.
FDA Regulations are further supported with fully compliant Nutritional Reporting and Labeling functionality. Analysis of the formula ingredients is performed via the Laboratory module (seamlessly) using a standard USDA ingredients database from which physical properties can be imported directly into the BatchMaster ERP inventory database. Labels can be customized for individual product packaging and international markets. Five separate FDA-compliant nutritional reports are also inherent.
FDA batch audit requirements are met with specific reports such as Batch Ticket Audit Report, Consolidated Transaction Report, Lot-tracking Report and QC Item history Report.
Lot Traceability also lies at the heart of BatchMaster ERP. Designed for maximum flexibility and instant recalls, Serial/Lot Tracking starts with customizable Lot Number configuration and automation of lot sizes. Prevent use of lots which are in Quarantine, Expired, or are too close to Expiry to be shipped. Select lots for use or shipment using numerous Lot-picking strategies – prioritize by FIFO, LIFO, FEFO and more, choose by Date, Number, QC Results or user-defined Lot Features. On-screen access to your relevant Lot data from any transaction screen. Lot explosion both forward and backward down to end-consumer level, with export to Microsoft Office®, facilitates a full product recall within seconds.
BatchMaster ERP - Process Manufacturing Software - Regulatory Compliance
