Data Integrity Program Assessment

The first step toward building a comprehensive and compliant Data Integrity program

Data Integrity Program Assessment

The Data Integrity Program Assessment is the first step toward building a comprehensive and compliant Data Integrity program. Our proven and standardised assessment approach to Data Integrity leverages elements that are currently in place, identifies gaps, assigns gap criticality and proposed remediation including quick wins. We assist customers on their digital journey, while helping to ensure that they have confidence in the quality and integrity of the data used to make decisions impacting product quality and patient safety.

The requirement to have one single source of truth and data that is Attributable, Legible, Contemporaneous, Original and Accurate as well as Complete, Consistent, Enduring and Available (ALCOA+) requires expertise that AVEVA can deliver.

Pillars of the Data Integrity Program Assessment

  • Assessment

    Data Integrity Program Assessment

    • Conduct high level assessment
    • Identify existing elements that can be leveraged
    • Identify gaps and assign criticality
    • Identify quick wins
    • Create report which will serve as basis for site roadmap

    System Assessments

    • Define system data flows
    • Conduct system assessments according to plan

  • Policy

    Data Integrity Policy

    • Draft site policy
    • Tie-in to QMS
    • Tie-in to Validation Program
    • Tie-in to IT policies

    Maintaining Data Integrity

    • Ensure key objectives of Data Integrity program are included in engineering, quality and validation projects
    • Ensure key objectives of Data Integrity program are covered by internal audits

  • Plan

    Data Integrity Plan

    • Define and inventory systems in-scope
    • Define systems assessment methodology and template
    • Define systems criticality and create assessment schedule
    • Define remediation methodology

    Data Integrity Program Progress

    • Periodically report on progress / update program status:
      • Completed assessments
      • Remediation plans
      • Schedule updates

  • Remediation

    Remediate Systems

    • Define and implement remediation plans for any gap identified during system assessments

    Remediation Completed

    • Once all systems have been assessed and remediations are completed, it is important to proactively pursue the objectives of the Data Integrity Program

  • Training

    Initial Training

    • Provide Data Integrity Initial Training to key stakeholders

    Advanced Training

    • Provide Data Integrity Awareness Training to all personnel
    • Provide Assessment Specific Training to SMEs

    Training Program

    • Include Data Integrity elements in the training programs to ensure personnel remain trained on key objectives of the Data Integrity effort

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Assessment Approach and Benefits

  • Holistic approach to data management strategy reaching across department silos to encourage a comprehensive approach
  • Expertise of global regulatory requirements and expectations, allowing findings and remediations to apply to multi-site, global Data Integrity strategy
  • Approach will leverage existing and current processes
  • Risk-based gap assessment with score-card system, including assessment of:
    • Data Integrity Policy
    • Quality Management System
    • Validation Program
    • IT Policies/Procedures
    • Training Requirements
    • System Inventory/Assessment
  • Report findings categorised by criticality and quick-win/high-impact identification
  • Path forward to proposed local and/or global remediation strategy
  • Platform/system agnostic

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Now What? Remediation

The outcome of Data Integrity Program Assessment will provide a detailed path forward on how to build on existing processes and procedures to develop a comprehensive, compliant and defendable Data Integrity program. One that is based on experience, best practices and a solid scientific and risk-based approach. Our experts can provide project management and remediation support throughout the entire Data Integrity program cycle with a scalable approach which allows for maximum flexibility in leveraging internal resources to ensure maintainability for the Data Integrity program throughout the entire data lifecycle.

Let us be your partner on your digitisation journey to reduce time to value,  improve efficiency, increase asset utilisation and ensure Data Integrity. Check out AVEVA Smart Manufacturing in Life Sciences

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