-
jl959 replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development 6 years ago
The FDA is strict on ensuring all guidelines are met when audits are conducted. Works logs are one of the documents auditors must review and reference during their visit. If work logs aren’t properly recorded for all employees, it will hinder the auditor’s assessment. As a result, high debilitating fines can be handed to the company. In more extreme cases, the FDA can even revoke the patent or license of the company. This will force the company to cease all operations until they apply for and receive the new license, which will delay the finish date. The financial strain of the fines coupled with the unexpected delay can completely kill the project.