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Interview: Best Practices from an Expert on the Quality Audit Process

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...

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Tags: document control software, audit, audit readiness, 3rd party audit, quality audit

Interview With a Quality Expert

Bobbi Lilek

Bobbi works as a Quality Systems Director for a rapidly growing biotechnology company that utilizes the ENSUR software for both Document Control and Quality Management. In order to maintain her company’s policy of strict customer...

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Tags: document management software, Quality Management System, FDA Electronic Signature, Quality, audit

How to Prepare for a Virtual Laboratory Audit

How to Prepare for a Virtual Laboratory Audit

Due to the rise of remote work policies stemming from the COVID-19 pandemic, in person laboratory auditing has been nearly impossible over the past year. Reacting to these difficulties, the FDA announced in March of 2020 that they would be scaling...

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Tags: Compliance, audit, fda audit, laboratory industry

4 Best Practices for Handling Non-Conformances

4 Best Practices for Handling Non-Conformances

No matter how hard you work to maintain your quality standards, you are bound to encounter non-conformances at some point. A non-conformance in quality management is defined as any type of deviation from a specification, a standard, or a production...

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Tags: quality management software system, supplier collaboration, audit, non-conformances

The 5 Fastest Ways to Fail an ISO Audit

The 5 Fastest Ways to Fail an ISO Audit

Preparing for an ISO audit is a necessary and complicated aspect of operating within a highly regulated industry. It is the job of the auditor to make sure all of your documentation and processes are running in line with every ISO regulation....

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Tags: quality management, quality management process, ISO 9001, audit

5 Tips for Improving the FDA Audit Process

5 Tips for Improving the FDA Audit Process

Over the last few years the Food and Drug Administration (FDA) has become progressively more aggressive and tactful in the way they conduct their audits. More often than not, companies are unprepared to manage an FDA inspection or to effectively...

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Tags: FDA compliance software, quality management software system, audit, fda audit

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