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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
For small and medium businesses (SMBs), being audit-ready isn't just a best practice—it's a necessity. With audits looming over various aspects of business operations, from finances to compliance, the stakes are high. Failing to meet audit...
Tags: audit, audit readiness, small business, SMB
In the fast-paced world of biotechnology, where innovation hinges on precision and collaboration, efficient document management becomes a cornerstone of success. With mountains of research data, protocols, regulations, and intellectual property to...
Tags: document management, Compliance, biotechnology industry, audit readiness
We interviewed DocXellent's resident quality audit expert and Chief Technology Officer, Tom Tassias, to learn from his extensive experience with third-party audits and get his insight into how companies can optimize their audit process to improve...
Tags: document control software, audit, audit readiness, 3rd party audit, quality audit