Why Audit Readiness Starts with PQS? In pharmaceutical manufacturing, audit readiness isn’t something to scramble for—it’s something to build into your everyday operations. A strong Pharmaceutical Quality System (PQS), as defined in ICH Q10, plays a central role in ensuring […]
How Audit Management Software is Transforming Pharma Audits Audits are a critical part of pharmaceutical manufacturing, ensuring compliance with regulatory standards like FDA 21 CFR Part 11, EU GMP, and WHO guidelines. However, traditional audit management is time-consuming, resource-intensive, and […]
How a Pharma Audit Management System Can Make Your Audits Stress-Free In the pharmaceutical industry, audits are a critical part of maintaining compliance with GMP (Good Manufacturing Practice) and other regulations. But let’s be honest—managing audits manually can be stressful, […]
Pharmaceutical audits play a vital role in ensuring that companies comply with industry regulations, maintain quality standards, and avoid costly mistakes. However, conducting these audits manually can be time-consuming and prone to human error. The solution? Audit management software in […]
In the pharmaceutical industry, regulatory audits are non-negotiable, essential for ensuring product safety, quality, and compliance. Whether it’s the FDA, EMA, or other regulatory bodies, facing an audit can feel overwhelming if you’re not well-prepared. But with a smart strategy […]
Quality. A common word used by everyone to signify that the activity performed is as per the defined standards. Pharmaceutical and life science are two industries that need to ensure quality to the core since deviations from quality can be […]
Companies dealing in Pharmaceutical, medical devices and biotech industries must meet various regulatory and quality requirements of various regulatory agencies and the most important them is FDA and ISO and rest depend on the market where you want to expand. […]
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