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manolo replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development 6 years ago
My field is regulated by The Joint Commission (TJC) and The Centers for Medicare & Medicaid Services (CMS). Every 3 years an on site audit is performed by either TJC, CMS or both. Not having our logs in order when the regulatory bodies arrive can contribute to the overall organization losing it’s accreditation. This will financially cripple the organization, and be a leading factor of the organization going out of business.