21 CFR 11 COMPLIANCE ASSESSMENT

ARTECH Associates provides 21 CFR Compliance assessments to organizations with GxP regulated facilities. For each computerized system under consideration, we can:

Perform Assessment & Gap Analysis

• Identify which systems are covered by the Regulation.
• Classify the system and determine the extent to which Part 11 is applicable.
• Evaluate system, procedures and controls for compliance with each Part 11 requirement.
• Identify and document each observed area of non-compliance.

Perform Corrective Action

• Recommend specific Corrective Actions.
• Plan Corrective Actions.
• Mentor Client personnel in implementing Corrective Actions.
• Provide assistance in implementing Corrective Actions.

Remember...

The road to compliance begins with a complete assessment and gap analysis. Know what you need. Contact us for an assessment of your needs.

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