Audit 

Whether it is developing your facilities' Inspection Readiness plan, hosting the audit, or developing recommendations and strategies to address previous audit observations, we can support your facility through all types and stages of a regulatory or customer audit.

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Quality System Development
Lucidyne can author and implement compliant Standard Operating Procedures (SOPs) governing all aspects of a cGMP operation. Quality Systems include but not limited to the following:

• Quality Manual

• Quality Policy

• Change Control Systems

• Deviation Procedures

• CAPA Systems

• Document Control

• Good Documentation Practices

• Supplier Management

• Training program

• Auditing

We can assess your company's compliance level by auditing the Quality System for adherence to applicable ISO standards and / or the Code of Federal Regulations (CFR). A comprehensive audit report will be provided at the conclusion of each audit.  We can also assist in closing the compliance gaps identified.

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