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ComplianceQuest insights and Perspectives

The Power of Watermarking

The earliest use of a watermark was around the year 1800. Watermarking was used to ensure the originality of the document. It typically consisted of an image, an emblem, or just plain text that appeared in various shades of lightness/darkness. It was sometimes created manually when the paper was manufactured by introducing variations in thickness…

CAPA – More Than What You Think It Is

Achieving greater quality in manufacturing, you need a means to implement improvements to an organization’s processes so that they eliminate causes of non-conformities or other undesirable situations. This process is commonly referred to as CAPA or Corrective and Preventive Actions. One cannot achieve compliance to ISO 9001, ISO 13485, GMP and myriad other quality standards…

A Fast Path to New Employee On-Boarding

Compliance standards set up by authorities such as Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA) and International Organization for Standardization (ISO) aim at enabling organizations to conduct their operations with good business practices. Quality management is one of the critical components of these standards. A need for trained and competent personnel…

Importance of a Non-Compliance Resolution Process

Non-compliance can be explained as a failure to fulfill the specific asks of a regulatory requirement, and can be due to either sub-par system performance or a lack of proper processes in place. System Non-Compliance might include a failure to capture information as per the regulatory objectives, while Process Non-Compliance might include not achieving operating…

Planned vs Emergency Change

Many view Organizational Change as an indicator of potential problems in the organization. However, this isn’t always necessarily true. In a lot of cases, the change is voluntary, and underlines the organization’s willingness to proactively recognize and exploit the potential opportunities latent in the organization or its circumstances. But whether you are always on a…

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