Pharmaceutical producers are under tremendous pressure to deliver superior quality of products by satisfying all quality and regulatory parameters. These pharmaceutical producers need to record every minute details of entire manufacturing process starting from raw material quality, equipment’s used, operator and supervisor name, API used, products deviation etc. to authenticate the quality benchmark.
Process XE-electronic batch recording software(EBR software) specially developed for Pharmaceutical industry to streamline, automate and simplified execution of various processes, compliance for Part 11 requirements , FDA audits, and validation and confirms to US FDA cGMP requirements, displays the accountability in each small stage in production of each batch. It provides a centralized, controlled repository for all executed batch test records and related data for easy batch review.
Process XE- electronic batch recording software (EBR software) is a smart platform which automate the process of preparing, releasing and controlling various pharmaceutical manufacturing documents (PMD) and master production control records (MPCR) and batch production control records (BPCR) are two most important of them. It comes with the configurable templates and readymade formats for various SOP’s for material management, room and equipment logs, specification control with versioning, inventory control, master batch records, security and audit logs. The requirements and quality checks from the SOPs are built into the application to provide greater quality and productivity.
- Qualification checks on all equipment and materials used
- Videos , photos and SOP for operators instruction
- Real time tolerance checking
- Automated calculations
- Step control with step-based work instructions
- Compliance flags indicating non-conforming data values
- Audit trails with operator identification and date/time stamp
- Trending reports and batch certificates
- Smooth integration with ERP, eQMS, eDMS and eLIMS etc
- Compatibility with any devices and OS allow you to use it on shop floor
Reasons to upgrade