Guide to Outsourcing Nearly every aspect of a medical device business can be outsourced, but to satisfy FDA, one company has to be accountable for the finished product. Ellen Esterline and Floyd ...
How often and how much does your firm think about quality? Every auditor is, by nature, committed to quality. Every firm has final quality control steps built into its production process. However, ...
Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and ...
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7 stats that will make you rethink your document management strategy
Forty-eight percent of workers struggle to find files, 45 percent of SMBs still use paper, and e-signatures can boost close ...
A PQRI expert working group provides case study examples of risk-management applications. The harmonized Q9 Quality Risk Management guideline from the International Conference on Harmonization (ICH) ...
Errors in technical work rarely happen because teams lack expertise. More often, mistakes occur due to unclear instructions, outdated files, or inconsistent documentation. As products, systems, and ...
Purpose-built electronic quality management systems are a better fit for CGT production than traditional technologies.
WIESBADEN, Germany - Geographic diversity, customer variety, organizational structure differences and a presence worldwide have led to varying business practices established across the U.S. Army Corps ...
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