Life Sciences Manufacturing

Manufacturers in industries such as pharmaceuticals, nutraceuticals and medical devices are under mounting pressure to maintain their competitiveness while simultaneously complying with an increasing array of regulatory requirements (lot control and traceability, quality assurance, CFR21 part 11, etc.)

Sage ERP X3: Solutions for FDA-registered manufacturers

Sage ERP X3 provides them with a flexible management solution aimed at meeting the most elaborate business processes in a simple and efficient way, while complying with the demanding quality requirements of FDA-registered manufacturers.

Seeking flexibility while meeting demanding regulatory requirement

Depending on their industry, manufacturers of life science products need flexible, industry-specific functionality to address their business system needs. While pharmaceutical and nutraceutical manufacturers need automated support for process or batch manufacturing environments involving formulation management, weight calculations and potency management, medical device manufacturers typically deal with discrete units in configure-to-order, make-to-order, assemble-to-order or make-to-stock environments.

But all life science manufacturers require support for full lot control and traceability, quality assurance and control, and in complying with FDA regulations such as CFR 21 Part 11.

Sage ERP X3 software solutions are flexible enough to accommodate this varying array of business functionality through the Sage ERP X3 Process suite for pharmaceutical and nutraceutical manufacturers and Sage ERP X3 Discrete for medical device manufacturers.

For example, both ERP software suites provide a fully-integrated quality control process that can rigorously enforce inspections to assure item conformance to any required characteristics, operational tolerances or expected results. Inspections can be conducted at key event points such as during receiving or at any stage of the production and packaging processes. Suspicious items or those that fail any inspection rules are automatically quarantined and designated for further inspection or disposal. The rules-based orientation of Sage ERP X3 assures blockage of any item from being used if it doesn’t have an acceptable quality status.