What You Need to Know About Vendor Audits
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation. The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more […]
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Avoiding these problems in GLP labs can save you a warning letter
Excerpted from The Journal of GXP Compliance There are recurring themes of observations documented in warning letters that relate directly to laboratory and study management. They are: 1. QA fails to do its job One common finding involves the failure of the quality assurance unit (QAU) to fulfill the require-ments of the GLP regulation. The following […]
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Digital Pen Speeds Data Management, Helps FDA Compliance
Digital Pen Speeds Data Management, Helps FDA Compliance Digital pen technology is an efficient data management solution that offers better operational visibility, enabling manufacturers to react quickly to the production process and respond to issues via immediate data access. Hyla Soft’s FactoryScribe is a lightweight web application built around Anoto digital pen technology. It helps […]
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