Ensuring pharma IT systems comply with 21 CFR Part 11 is essential. With growing regulatory demands and data security concerns, compliance is crucial for protecting data integrity, maintaining trust and avoiding costly penalties. But what does compliance truly entail and why should it be a to…
IT systems are important in maintaining operations, ensuring compliance and safeguarding data integrity in the pharma industry. However, meeting regulatory requirements for pharmaceutical IT systems can be complex and challenging.
With evolving standards and regulations such as 21 CFR…
In the pharmaceutical industry, regulatory authority inspections are not just a formality—they are a critical safeguard to ensure that products are manufactured, tested, and distributed in a safe, effective, and compliant manner. However, effective inspection readiness goes beyond documentatio…
One common misconception we notice in various parts of the world is that marketing offices are exempt from GDP compliance because they don’t PHYSICALLY handle, store, or distribute medical products. This is a dangerous oversimplification because your marketing office influences WHO distributes…
Drug manufacturing audits are crucial for ensuring pharmaceutical and biotech companies meet quality assurance and regulatory compliance standards. These audits verify adherence to GMP and GDP and identify areas for improvement. For success in the highly regulated industry, proper audit prepa…
A single lab mistake can result in regulatory penalties, delayed product launches or loss of trust. Good Laboratory Practices (GLP) ensure regulatory compliance, patient safety and research integrity. Beyond following rules, GLP helps build a reputation for precision, excellence and accountab…
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