Get the free Annex 11: Impact Analysis of All Policy Measures

This document provides an assessment of the impacts of 77 policy measures within the EU pharmaceutical regulatory framework, focusing on various policy blocks such as support for innovation, antimicrobial

How to fill out annex 11 impact analysis

How to fill out annex 11 impact analysis

1. Review the purpose of Annex 11 - Understand its importance in the context of computerized systems in regulated environments.
2. Identify the scope of the impact analysis - Determine which processes, systems, and components are involved.
3. Gather relevant documentation - Collect existing system documentation, user manuals, and any previous risk assessments.
4. Analyze the system - Evaluate the functionality, data integrity, and compliance aspects of the system.
5. Identify potential impacts - List potential risks to data integrity, confidentiality, and system availability resulting from changes or issues.
6. Assess the severity of impacts - Rate the potential impacts based on their likelihood and consequences.
7. Develop mitigation strategies - Propose controls or modifications to reduce identified risks.
8. Document findings - Clearly write down the impact analysis, including methodologies, results, and recommendations.

Who needs annex 11 impact analysis?

1. Organizations that utilize computerized systems in regulated industries, such as pharmaceuticals, biotechnology, and medical devices.
2. Quality assurance teams responsible for compliance with regulatory requirements.
3. System administrators and IT staff involved in managing and maintaining regulated systems.
4. Regulatory agencies that require proof of impact analysis for audits.
5. Internal auditors assessing compliance and risk management strategies.

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What is annex 11 impact analysis?

Annex 11 impact analysis refers to an assessment process that evaluates the effects of proposed changes in systems or processes related to pharmaceutical quality and compliance, specifically under Annex 11 of the EU Guidelines for Good Manufacturing Practice.

Who is required to file annex 11 impact analysis?

Manufacturers and organizations involved in the production of pharmaceuticals, medical devices, or other regulated products that require compliance with EU regulatory standards are typically required to file an annex 11 impact analysis.

How to fill out annex 11 impact analysis?

Filling out an annex 11 impact analysis involves identifying the proposed changes, assessing their potential impact on quality and compliance, documenting the evaluation findings, and outlining any necessary actions or adjustments to mitigate risks.

What is the purpose of annex 11 impact analysis?

The purpose of the annex 11 impact analysis is to ensure that any changes made to systems or processes do not negatively affect product quality, patient safety, or compliance with regulatory standards.

What information must be reported on annex 11 impact analysis?

The information that must be reported includes a description of the proposed change, the rationale for the change, an assessment of potential impacts on quality and compliance, actions taken to mitigate risks, and the outcomes of the analysis.