The medical device industry is one of manufacturing's most closely regulated industries. Complaints handling is one of the industry's key regulatory issues. This paper presents the results of a survey on how companies are managing their complaints handling processes to help reduce noncompliance risks. Compliments of Compliance-Alliance
The selection of an EDMS or QMS solution can be an arduous process. However, each offers features and functionality that drive business requirements and ensure compliance, providing a cost-effective and efficient solution that, if managed professionally and driven to a successful roll-out, will dramatically streamline document flow and retrieval, enable compliance, and deliver a significant positive impact to the organization's bottom line. Compliments of Maxiom Consulting Group, Inc.
This document consolidates all GLP questions answered by the agency, clarifies the questions and answers as needed, and relates the questions and answers to the specific pertinent provisions of the GLPs. It represents a digest of some 30 letters, 160 memoranda of telephone conversations, 34 memoranda of meetings and 30 miscellaneous correspondences that have been issued by agency personnel. Compliments of EnKap
This article excerpt focuses on preparing your company for an FDA inspection for nonclinical laboratory inspections. Compliments of enKap