AssurX Blog
Straight talk for regulated industries.
FDA Warning Letters Show Document Management System Issues in Food Industry
Documentation is a subject that comes up frequently in U.S. Food and Drug Administration (FDA) warning letters and 483 observations. In fact, documentation is cited in virtually every [...]
AssurX Adds EHS Incident Management to its Quality Management Platform
PRESS RELEASE: ASSURX ADDS ENVIRONMENTAL HEALTH AND SAFETY (EHS) INCIDENT MANAGEMENT TO ITS QUALITY MANAGEMENT PLATFORM Turnkey solution collects, analyzes, and reports the data requi [...]
Planning for Successful Preparation of the NERC CIP ERT
Cybersecurity regulations in the energy industry create a constantly evolving challenge to efficiently monitor, manage, and report on compliance activities. The NERC CIP Evidence Reque [...]
Tips for Preparing for an ISO Certification Audit
Recent ISO data shows a growing number of certificates being issued across all standards. A notable increase is especially seen in ISO 9001 (Quality Management), ISO 14001 (Environment [...]
An Overview of the FDA Draft of CSA Guidance for Quality Systems
In September 2022, the (FDA) released draft computer systems assurance (CSA) guidance clarifying software validation requirements for medical device manufacturers. The guidance signifi [...]
6 Common Reasons External Quality Audits Fail
In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, and activities are effectively aligned with desired objectives. Th [...]
