June 2, 2020/
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In the highly regulated pharmaceutical industry, navigating compliance amidst evolving standards is a huge challenge. This blog explores the transformative benefits of integrating a Learning…
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Guaranteeing full adherence to regulatory standards, our commitment lies in upholding the reliability, and trustworthiness of your data assets.
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GAMP guidance aims to safeguard patient safety, product quality, and data integrity in the use of GxP computerized systems. It aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements by building upon existing industry good practice in an efficient and effective manner.
This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfil certain functionalities. The application should be validated; IT infrastructure should be qualified. Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.
21 CFR Part 11 is an FDA regulation with the intent to ensure the authenticity and non-repudiation of electronic records and signatures. It applies when electronic records are created, modified, maintained, archived, retrieved, or transmitted to meet the requirements defined in predicate rules
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In the highly regulated pharmaceutical industry, navigating compliance amidst evolving standards is a huge challenge. This blog explores the transformative benefits of integrating a Learning…
The life sciences industry is one of the most rapidly growing industries globally. Due to this rapid growth, hiring new vendors and international expansion life…
Documents are an essential part of almost every organization and managing documents from several sources is indeed a challenging task. Based on the nature of…
Tech Qualitas team has demonstrated a high level of expertise and professionalism in navigating the complexities of CSV and QMS processes at Scilife. They exhibited a thorough understanding of our industry requirements and ensured seamless adherence to regulatory requirements while handling validation of different modules, internal/external audits, and ISO 9001:2015 compliance.
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