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A practical guide to the 21 CFR Part 11 criteria your e-signature workflow must meet, and how to evaluate the systems that claim to meet them.
Tags: document control software, quality management software, Electronic Signature, Compliance, audit readiness, 21 CFR Part 11, FDA
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Quality management is essential in the life sciences industry to ensure the safety and efficacy of products. Whether it's pharmaceuticals, medical devices, or biotechnology, quality management systems help to establish and maintain high standards...
Tags: quality management software, Quality Management System, life sciences
For medical device companies, meeting ISO 13485 standards is necessary for many reasons. The standard was written to support medical device manufacturers in designing a Quality Management System that establishes and maintains the effectiveness of...
If you want to ensure you are providing consistent products or services throughout your organization, you must implement an ironclad quality management system, or QMS. Quality control management ensures that what your company delivers, and the...
Tags: FDA compliance software, Quality Control Management, quality management, quality management software, quality management software systems
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With consumers placing an increasingly large emphasis on product quality, meeting regulatory standards like ISO 9001 is more important than ever. To keep up with the ISO 9001 group of standards, many companies find a digital quality management...
Tags: quality management software system, quality management software, ISO 9001, internal audit
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Since the software’s conception, many companies have utilized Lotus Notes for their documentation needs. But what exactly is this system and how is it used? Created in 1982 and bought by IBM in 1995, Lotus Notes is an enterprise email system. It...
Tags: quality management software, lotus notes, document management system, ibm notes