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Do you Manufacture Pharmaceutical Products?

SYSPRO ERP software provides complete compliance management for pharmaceutical manufacturers and distributors. With integrated capabilities to meet regulatory requirements for the Bioterrorism Act of 2002, HACCP, SOX Compliance, and Good Manufacturing Practices (GMP) support. Edgeware delivers a fully-integrated ERP software solution that is both functionally rich and designed to support the pharmaceutical industry’s business software requirements.

There are many benefits from using SYSPRO as your ERP solution:

  • Single Integrated Solution
  • Comply with GXP Guidelines
  • Implement Advanced Quality Management
  • Promote Best Practices Across Your Value Chain

 

Advanced SYSPRO Features:

  • Manage approved customer lists by item, batch, and country
  • Reserve batches that align precisely with batch attributes and batch specifications defined by item and customer
  • Secure Qualified Person approvals before shipment with electronic signatures
  • Generate approved vendor list and manufacturer list, backed by quality control integration for incoming goods
  • Ensure consistency with a structured vendor/manufacturer qualification process
  • Item approval workflow includes automated, selective blocking for unapproved items
  • Container/lot management offers full batch and container traceability, including batch lifecycle and status changes, secured by electronic signature
  • Inventory journals approval is secured by electronic signature
  • Manage unit conversions by batch according to the actual batch assay and potency
  • Manage reworking and reprocessing activities
  • Generate production batch record
  • Save time and reduce paper-based activities by managing master batch records within the system, automatically linked to the formula version
  • Manage preventive and corrective equipment maintenance with multi-level object control
  • Preventive and ad-hoc work orders integrate with Materials Resource Planning (MRP) and equipment availability
  • Manage spare parts to ensure monitoring and optimization of costs, consumption and availability
  • Full traceability of maintenance activities includes workflows and electronic signatures
  • Quality order approval workflow equips users with a graphical interface, multiple levels of review, approval and escalation secured by electronic signature, and a conditional release process
  • Robust integration connects stability studies and clinical and analytical services with project management
  • Streamline sample management, reduce tests, and produce accurate sampling plans based on a statistical approach
  • Test criteria based on mathematical calculations with multiple steps in compliance with US, EMA, Latin American and Japanese regulatory requirements
  • Electronic signature includes limited validity period and user lock-out if a certificate is repeatedly violated, as required by 21 CFR Part 11, Paragraphs 11.10, 11.200
  • Use extensible, dynamic record-level security and permissions to define access rights and functions for a user group and document status
  • Calculate full costs for items, including direct and indirect costs
  • Capabilities include full alignment with sales and manufacturing forecasts, cost center budgets (quality, purchasing, indirect manufacturing, etc.), and product standard costs

SYSPRO Customers

Gericare-Pharmaceutical

puracap-pharmaceutical