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Medical

Global quality and compliance management systems and processes are critical for companies competing in the FDA-Regulated industries. These companies face the dual pressures of stringent and increasing regulatory pressure, and the need to streamline internal operations and supply chain interactions to squeeze out non-value-added costs. A solution can designed from the ground-up to enable companies in these industries to achieve regulatory compliance within their operations through auditable root-cause analysis and corrective actions, document lifecycle management and comprehensive records management.

DIR's suite of custom applications for FDA-Regulated industries can include Non-Conformance Management (NCM), Corrective and Preventive Actions (CAPA), Out-Of-Specification (OOS), Variance, Audit, Training, Complaints, Change Control and Document Management. These solutions feature built-in compliance with 21 CFR Part 11 regulations and cGMP standards. DIR's impressive partner network provides additional validation and consultative services.

DIR's customers in FDA-Regulated industries enjoy business benefits including:

  • Ensured compliance with 21 CFR Part 11 requirements.
  • Reduced cost of compliance by automating quality and compliance management tasks.
  • Reduced exposure to product recalls and associated costs
 
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