Pharmaceutical Software ERP Solutions Thats Right For Your Business!
Managing Compliance with 21 CFR Part 11
Compliance with regulatory requirements is a business-critical need that must be maintained, and the FDA recognizes the role of business software in helping companies manage compliance. Sage ERP X3 offers embedded functionality to maintain audit trails, digital electronic signatures, document signatures, validation scripts and security safeguards.
Proactive Regulatory Compliance for Biopharmaceutical Global Competitiveness
Every country has its own regulators and approach to regulating life science companies. Some are more established than others, and the most established (such as the U.S.'s FDA, EU's EMA, and UK's MHRA) frequently issue new guidelines. This is challenging enough when targeting a few countries, and will become far more difficult with each new country added to the base.
Managing Government Regulations with ERP
More and more, companies are under pressure to maintain their competitiveness while complying with an increasing array of regulatory requirements. And more than any other sector, manufacturers bear the highest share of the cost. How companies manage their response to these mounting regulations can have a significant impact on the bottom line.
Fully integrated quality control.
Because all pharmaceutical manufacturers require support for full lot control and traceability, quality assurance and control, and compliance with FDA regulations such as CFR 21 Part 11, Sage ERP X3 pharmaceutical software delivers a fully integrated quality control process. Rigorously enforce inspections and ensure your products conform to required characteristics, operational tolerances or expected results. Conduct inspections at key event points or throughout the production and packaging processes, and automatically quarantine suspicious or substandard items for further inspection or disposal. The rules-based orientation of Sage ERP X3 prevents usage of any item that lacks an acceptable quality status.