Pharmaceuticals

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Pharmaceuticals

"Patients, doctors, and hospitals rely on your products. With so much at stake, your organization needs to have accurate, timely information. Columbus IT Pharma Suite lets you monitor the pulse of your business."-- Jan Olesen, Vice President, Western Europe, Columbus IT.

Since the pharmaceutical industry is so tightly regulated, with long lead times from research to production, it's important for your company to be as flexible and efficient as possible. If you can get a medicine to market faster or more affordably, you can leapfrog the competition.

Columbus Pharma Suite is the integrated pharmaceutical, life science, and medical technology solution your organization needs to succeed. With an enterprise-wide information system, you'll be able to share information among employees, track data for management, and give customers the exemplary customer service that increases market share.

 

Solid and Trustworthy

Built on the foundation of Microsoft Dynamics AX, Microsoft's premier ERP solution, Columbus Pharma Suite enables you to use the stringent regulatory guidelines required by:

  • NNIT, the consulting arm of Novo Nordisk, CFR 21, Section 11 - Electronic Signatures
  • U.S. Food and Drug Administration (FDA) Regulatory Issues.

GMP Compliance

To use Good Manufacturing Practices, your organization needs the sophisticated, error-free auditing that Columbus Pharma Suite provides. Among other features, you'll benefit from:

  • An audit trail, vendor qualification, batch records and pick lists.
  • Logging of all input tables and fields, as desired.
  • Inputting, changing, or deleting the audit trail.
  • LIMS integration/deviation and event management.
  • Electronic time-stamping of all database records.
  • Analytics of electronic records, electronic signatures, and material receipts.

The Features You Need

  • Columbus Pharma Suite has an excellent and comprehensive set of project management and tracking tools, so you'll always be on time and on budget:
  • Baseline plan with timelines for each activity.
  • Synthesis scheme displaying planned reaction.
  • Project info containing all relevant data.
  • Quotation with full breakdown of projected costs.
  • Various internal and external tracking tools providing real-time control over progress and resources spent.
  • Chemical view and project management view.
  • Project planning in synthesis steps.
  • Project tracking in project phases (research, laboratory, production, release analytics, shipment).
  • Inventory built on a database of molecules. BOMs are created from chemical synthesis scheme of molecules.
  • System supports specifications from a Laboratory Information Management System (LIMS by applied Biosystems).
  • Ready to use interface for LIMS (Laboratory Information Management System) integration / Supports tax - volatile organic compounds (VOC).

More Details

Download the PDF fact sheet on Columbus IT Pharma Suite

Next Steps

Did you know?

“Clearly, the use of electronic technology has many advantages – in saving time and therefore money, but also in improving accuracy (and compliance), security and maintenance (such as safe and affordable storage of critical documents).” -- 2005 Liquent Regulatory Affairs Trends Survey.