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21 CFR Part 11 Compliance Checklist

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The FDA's 21 CFR Part 11 requires companies to validate their electronic systems and documents for quality and compliance. Automated solutions are the most effective for this. This checklist can help ensure you invest in the right solution.

  • Automated solution for 21 CFR Part 11 compliance
  • Automated personnel training
  • Auto-generated audit trails for any captured document
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What Does 21 CFR Part 11 Require?

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Authentic Electronic Records

21 CFR Part 11 requires assurance of the authenticity of electronic records. To maintain compliance, quality staff need a system that includes functionality to delineate user permissions for every document in the vault system.

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Computer System Validation

The FDA requires any electronic system used to manage compliance-oriented documents and processes to be validated. Automating your data and quality processes with a digital solution will make it easier to validate your system.

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Effective Change Control Management

Document controls must provide revision controls, change controls and time-based system modifications. An effective electronic system can automate these integral processes.

Don't take quality for granted. Entrust your compliance to the right solution.

You don't want to take chances with 21 CFR Part 11 compliance. To make sure you invest in the right 21 CFR Part 11 software, make sure you kick the tires and look under the hood. Use this compliance checklist to find the tool that will take your company's quality and compliance higher.

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