Regulatory Compliance

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Prime Technologies	Calibration Management Helps Ensure Compliance The right software can simplify and strengthen your quality practices. W Whether your quality practices are guided by the technician of an unacceptable result. Subtle performance need for compliance with the Food and Drug variations can directly impact product quality. Administration (FDA), International Organization Regardless of what your company produces — food, bev- for Standardization (ISO) ...
MSDS Writer	GHS Impact on the Regulated Community As OSHA's Hazard Communication Standard (HCS) nears its 25th anniversary since being adapted, the agency is considering modifications to the standard by incorporating elements of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). This system was initially adapted by the United Nations in 2002 with the goal of having as many countries as possible implement it by ...
Blue Mountain Quality Resources, Inc.	Regulatory Asset Management: Harmonizing Calibration, Maintenance and Validation Calibration, maintenance and validation activity, despite operating within the same department in some organizations, have generally been managed separately, each with their own procedures and their own computerized management systems. Since even calibration and maintenance professionals tend to access records differently and track different types of information, these separate and unconnected ...
DEACOM	Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry Pharmaceutical manufacturing executives today are all too familiar with industry regulations such as Title 21 CFR Part 11 and current good manufacturing practices (cGMPs). However, many drug companies still struggle to comply with these and other U.S. Food and Drug Administration (FDA) requirements. In 2008 alone, the FDA issued 43 warning letters to pharmaceutical companies for regulatory ...
American Health Sciences Institute	Buyer Beware! How to Develop a Practical (and Compliant) Vendor Qualification ... Under the principle of caveat emptor, the buyer takes the responsibility for the condition of the items or quality of the services that he or she purchases. Prior to the current consumer protection laws, buyers had no warranties for the goods or services that they purchased. Today, most states require goods to be of “merchantable or sellable quality”. As this condition is often next to impossible ...
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Regulatory Compliance Research Library