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September-October, 2007 | Archives | 21 CFR Part 11: Complying doesn’t have to be a burdenCompliance with regulatory requirements is a business-critical need for life sciences companies and other FDA-regulated industries that must be maintained, and the FDA recognizes the role of business software in helping companies manage CFR Title 21, Part 11 compliance. Sage ERP X3 offers embedded functionality to maintain audit trails, digital electronic signatures, document signatures, validation scripts and security safeguards.
| READ MORE | Sage ERP X3: Reducing Corporate Risk with Audit TrailsWith concerns regarding corporate accountability and regulations such as Sarbanes-Oxley, companies are subject to greater scrutiny and larger penalties for poor corporate governance and security. And, those operating in government-regulated industries such as food and beverage or life sciences must comply with other legislations like HACCP and 21 CFR Part 11. Much of the risk from these legislations has been placed on IT systems, which are subject to government auditing. Without an acceptable audit trail, a company’s applications may not be auditable and an auditor could assess a material weakness or impose a severe fine for violations.
Sage ERP X3 enables companies to reduce corporate risk by providing regulatory-required audit trails and safeguarding the integrity, accuracy and security of enterprise data. The audit trail functionality is embedded in the software and records all important actions.
Watch a Live Demo of Sage ERP X3's decision-making capabilities, including Dashboards, User Portal and Audit Trails.
| LAUNCH VIDEO | Customer SpotlightA manufacturer of products for interventional radiology and vascular surgery headquartered in Skokie, IL, UreSil, LLC was operating on an MRP system that the company feared would become unsupportable due to a number of third-party customizations. Prior to its acquisition of Sage ERP X3, the company faced limitations in planning and flexibility hindered its ability to run an efficient business. More importantly, complying with FDA regulations and maintaining the required documentation proved to be a challenge all its own.
With Sage ERP X3, tracking systems for FDA regulations are streamlined and manageable. Planning processes are tightened and the company now operates with a just-in-time planning philosophy, minimizing inventory and warehouse space. Finished goods lead time was reduced by 50 percent. Automatic print-and-place labeling reduced the process by 1.5 man days per week.
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