FDA 21 CFR Part 11 & EU Annex 11 Compliance

Compliance with FDA 21 CFR 11 Electronic Records; Electronic Signature and EU Annex 11 Computerised Systems is a must for the pharmaceutical, biotech, medical device, and clinical research industries.

Part 11 and Annex 11 Gap Assessments

ProPharma’s consultants have many years of industry experience implementing Part 11 and Annex 11. They leverage this experience to provide your organization with the benefits of a Part 11 or Annex 11 Gap Assessment, including:

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Time to proactively remediate any critical deficiencies before an audit, rather than having them discovered by a regulator or customer

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Insight to focus audit preparation activities on only those areas that need attention.

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Confidence in the success of the next audit or inspection of your systems.

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Part 11 & Annex 11 Compliance Experts

ProPharma’s Part 11 and Annex 11 experts follow risk-based GxP principles to prioritize the processes and systems to assess. They know which areas auditors are most likely to target and apply the following approach to assessing your systems and software validation procedures.

Part 11 & Annex 11 Compliance Assessment Approach

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Meet with you to discuss your industry, your products, and your markets to determine the exact section of Part 11 and Annex 11 with which you need to comply.

Meet with you to discuss your industry, your products, and your markets to determine the exact section of Part 11 and Annex 11 with which you need to comply.

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Discuss any specific areas of concern. For example, you might feel confident about your software quality policies, but are uncertain whether or not your validation documentation will withstand...

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Discuss any specific areas of concern. For example, you might feel confident about your software quality policies, but are uncertain whether or not your validation documentation will withstand serious scrutiny.

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Tailor ProPharma’s standard 200+ question Part 11 and Annex 11 assessment checklist to place the focus on the areas that are most important to your organization.

Tailor ProPharma’s standard 200+ question Part 11 and Annex 11 assessment checklist to place the focus on the areas that are most important to your organization.

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Conduct the Assessment in a manner similar to a regulator or potential customer. We ask the same tough questions, inspect your evidence, and challenge your practices.

Conduct the Assessment in a manner similar to a regulator or potential customer. We ask the same tough questions, inspect your evidence, and challenge your practices.

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Provide a Part 11 and Annex 11 Assessment Report with ratings for each question. Areas of non-compliance will be categorized as either “critical”, “major”, or “minor” in alignment with a risk-based...

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Provide a Part 11 and Annex 11 Assessment Report with ratings for each question. Areas of non-compliance will be categorized as either “critical”, “major”, or “minor” in alignment with a risk-based compliance program.

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Deliver a Compliance Action Plan with a list of specific, prioritized activities to complete to achieve Part 11 and Annex 11 compliance.

Deliver a Compliance Action Plan with a list of specific, prioritized activities to complete to achieve Part 11 and Annex 11 compliance.

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Host follow-up meetings to ensure that you understand the Part 11 and Annex 11 assessment results and recommended remediation activities.

Host follow-up meetings to ensure that you understand the Part 11 and Annex 11 assessment results and recommended remediation activities.

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Part 11 and Annex 11 Compliance Services

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Computer System Compliance

Computer System Compliance

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IT Process Compliance

IT Process Compliance

Submissions

Validation Compliance

Validation Compliance

Computer System Compliance

Part 11 and Annex 11 contain very specific functional requirements for regulated systems. ProPharma’s consultants work with your technical experts to determine the specific system configurations needed for compliance. When systems require customization, they review the designs to ensure that the end-result will be compliant from the first release.

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IT Process Compliance

Regulations require procedures and controls for GxP systems, such as back-up, disaster recovery, security, access management, risk assessment and management, change control, validation, issue management, and record retention. ProPharma’s consultants not only develop the Standard Operating Procedures (SOPs) to meet regulatory requirements and incorporate industry-standard practices, but also ensure that the SOPs are tailored to your organization’s roles and responsibilities, technologies, and QMS infrastructure.

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Validation Compliance

Computer System Validation? Computer Software Assurance? ProPharma has the experts to work with you to develop a risk-based methodology whether it’s your organization’s first validation project or you need to bring an older validation package into compliance with modern standards.

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Optimize Compliance with Part 11 and Annex 11 Expertise

Unlock the full potential of your compliance strategy with our expert guidance on FDA 21 CFR Part 11 and EU Annex 11. Ensure your systems meet the highest standards of data integrity and regulatory compliance by partnering with us today.

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