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Pharmaceutical Software ERP Solutions That is Right For Your Business!

pharmaceutical ERP Software SolutionsManaging Compliance with 21 CFR Part 11

Compliance with regulatory requirements is a business-critical need that has to 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 and pharmaceutical 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 customer 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, pharmaceutical manufacturers bear the highest share of the cost. How companies manage their response to these mounting regulations can have a significant impact on profits.

  • 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. Pharmaceutical companies have to rigorously enforce inspections and ensure products conform to required characteristics, operational tolerances or expected results on a consistent basis. Regular inspections have to occur at key event points and throughout the production and packaging processes. Suspicious or substandard items have to be automatically quarantined for further inspection or disposal. The rules-based orientation of Sage ERP X3 prevents usage of any item that lacks an acceptable quality status.


pharmaceutical software solutions

Sage customer, Boiron USA uses Sage ERP X3 to manage their pharmaceutical operations. Read more.

Pharmaceutical manufacturers have specialized needs. Use ERP to manage them. Read more.


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