Post-Approval Change Management QRM
Easily understand the impact of a proposed change and define acceptance criteria to ensure that safety, quality, and efficiency are never compromised.
Benefits this Solution Provides
Implement Post-Approval Changes 60-70% Faster
Optimize your post-approval change management protocol (PACMP) development.
Perform Risk assessments 40-50% Faster
Connect all of your risk data using robust QRM tools.
Simplify Regulatory Approval
Use reporting tools to generate evidence to support your submissions.
Fully align with the ICH Q12 guideline.
The QRM Platform’s Role in PACMP Development
- Optimize risk assessments to understand what might be affected by the proposed change, then suggest a reporting category appropriate for the change.
- Describe specific tests and suggest acceptance criteria using risk management tools to accurately assess the impact of changes after PACMP approval.
- Use the automatic comparison module to compare multiple assessments and see the differences before and after the proposed change.
Mitigate Potential Risks
- Determine if the current control strategy remains valid or if additional changes are needed because of the proposed change.
- Gather previous knowledge from prior experience with your product or a similar product related to development, manufacturing, characterization, batch release, and stability to support risk mitigation.
- Implement multiple changes, then effectively address the potential cumulative risk.
Streamline Post-Approval Change
- Use a range of reporting tools to support PACMP regulatory submission.
- Increase your chances of PACMP approval in step one and ensure that your tests and study results in step two meet the defined acceptance criteria to minimize time to market.
- Guarantee that ongoing verification is performed in the pharmaceutical quality system to ensure there is no adverse effect associated with the change.
What Can You Expect From Implementing Our Solution?
|Poor risk assessment ― risk data is recorded separately; higher subjectivity in risk qualification/quantification; resource- and time-intensive process.||Effective risk assessment ― risk data is gathered in one place; QRM tools eliminate subjectivity and streamline the process.|
|Process approval can take longer, leading to drug shortages.||Faster post-approval change implementation reduces time to market.|
|The risk assessment can be biased.||Risk tools help you see the impact of a change on the final product and compare the risk assessment before and after the change is implemented.|
|Manual reports take too long to generate and increase data integrity risks.||Automatic reports are easy to generate and provide adequate evidence to support regulatory submissions.|
|Before||Poor risk assessment ― risk data is recorded separately; higher subjectivity in risk qualification/quantification; resource- and time-intensive process.|
|After||Effective risk assessment ― risk data is gathered in one place; QRM tools eliminate subjectivity and streamline the process.|
|Before||Process approval can take longer, leading to drug shortages.|
|After||Faster post-approval change implementation reduces time to market.|
|Before||The risk assessment can be biased.|
|After||Risk tools help you see the impact of a change on the final product and compare the risk assessment before and after the change is implemented.|
|Before||Manual reports take too long to generate and increase data integrity risks.|
|After||Automatic reports are easy to generate and provide adequate evidence to support regulatory submissions.|
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