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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
Today's digital landscape is full of complex regulations and security threats. Organizations navigate a complex web of data privacy laws, industry-specific compliance mandates, and the ever-present risk of cyberattacks. In this dynamic environment,...
Tags: Quality, audit, audit trails
Step-by-Step Guide to Comprehensive Internal Auditing
Tags: quality management, audit, internal audit
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
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...
Tags: document management software, Quality Management System, FDA Electronic Signature, Quality, 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...
Tags: Compliance, audit, fda audit, laboratory industry
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...
Tags: quality management software system, supplier collaboration, audit, non-conformances
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....
Tags: quality management, quality management process, ISO 9001, audit
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...
Tags: FDA compliance software, quality management software system, audit, fda audit