Utility System Qualification for the Pharmaceutical Industry

Pharma and medical equipment manufacturing is a highly-regulated industry. Given the stress on product quality and the widespread impact of substandard production on public health and safety, utility system qualification is a critical step that companies must take towards ensuring that all their products comply with federal laws and regulations. Utility Systems in Pharma In […]

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How Should Design Qualification Be Performed?

Designing equipment to meet specific requirements always has an element of risk, but proper equipment validation and qualification can reduce that tremendously. IQ OQ PQ protocols are pretty straightforward. However, design qualification (DQ) can be a bit of a handful. Regulatory authorities don’t specify the process too well, using terms like “could”, “typically” and “should”, […]

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