The fastest route between your current status and full 21 CFR part 11 compliance of your IT and electronic equipment.
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You wonder what steps to take towards full compliance according to 21 CFR part 11?
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You want to avoid unnecessary work and costly detours?
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You don't want to re-invent the wheel?
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BioMedion's Compliance Roadmap is a structured, pre-defined workshop and consulting package. Upon completion, you will have all necessary information and documentation to start implementing 21 CFR part 11 compliance in your organization. Cost effectively and without detours.
You will know
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What you have to do.
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What you don’t need to do.
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The benefits and potential pitfalls of each implementation step.
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How to estimate the time, resources and budget needed.
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How to utilize electronic compliance to save money in daily operations.
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The Compliance Roadmap package includes
- Kick-off workshop for status assessment and definition of goals
- Interpretation of the rule (21 CFR part 11) for your organization
- Assessment of all processes relevant to electronic compliance
- Assessment of all systems and data relevant to electronic compliance
- Priority plan based on FDA's Risk Based Approach
- Results workshop: Results and optimization of compliance implementation
- Documentation of results and Implementation Master Plan
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Download Fact Sheet
Compact facts about the Compliance Roadmap package
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