Data Integrity in the COVID-19 Era and Beyond - The Real-World Costs of Data Integrity


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COVID-19 has spread across the globe and, in an effort to quell the pandemic, the FDA responded with guidelines to expedite effective treatments and devices. They’ve set new regulations meant to hasten the development and approval of products that could prevent, diagnose or treat the virus.

These guidelines, along with the Coronavirus Treatment Acceleration Program, Operation Warp Speed and growing public pressure, have rapidly pushed forward the process of finding solutions to this massive health crisis.

But this swift pace hasn’t absolved manufacturers and researchers of their long-held data integrity responsibilities. While the processes may be moving at a quicker pace, these standards remain steadfast.

Do you know what practices are best to create, maintain and archive your data? Is your team using data integrity concepts to increase productivity? How has your organization been using its risk management strategies when it comes to data?

  • Part I — The Impact of COVID-19: Complying with Data Integrity Guidelines in the Midst of a Pandemic

    1. Data integrity and practices in the age of the COVID-19
    2. The impacts of COVID-19 on operations and supply chain management
    3. FDA regulations around data and COVID-19
    4. Inspection and audit practices, including virtual interactions and best practices

 

  • Part II — Key Issues in Data Integrity: Today and Tomorrow

    1. Managing Suppliers
      1. Keeping suppliers on track during a global pandemic
      2. Using technological developments to secure supply chains
      3. Dealing with problematic suppliers

 

    1. Measuring Testing and Validation Requirements
      1. Ensuring testing and validation meets good manufacturing practices requirements
      2. Taking advantage of technological updates
      3. Adapting to the “new normal” after the pandemic

 

    1. Dealing with Digital Transformation
      1. Making AI and blockchain work for you
      2. Complying with electronic submission requirements
      3. Preparing for post-pandemic digital obligations

 

Part III —

·         Document and Data Creation, Maintenance and Archival: Best Practices

    1. Creating the data and documents you need to better obtain information for inspection compliance
    2. Maintaining and preserving documents through the latest technology
    3. Ensuring the deployment of industry best practices in inspection compliance

 

  • Increasing Productivity through Effective Implementation of Data Integrity Concepts
    1. Determining which key data integrity concepts will best serve your organization
    2. Understanding how data integrity adherence can benefit both compliance and productivity
    3. Finding the lessons COVID-19 is teaching us about data integrity

 

  •  Deploying a Solid Risk Management Strategy for Data Integrity
    1. Applying the ICH Q9 guidance when implementing an effective risk management strategy around data integrity
    2. Making sure your team has meaningful and effective risk management strategies based on the design, operation and monitoring of systems and controls, along with the risk to patients, process and product
    3. Finding the unique risk mitigation strategies your team can employ to ensure the integrity of electronic data systems
    4. Using audit trails as part of a risk management strategy
    5. Remediating data integrity problems through a risk management strategy

 

Data integrity compliance issues should never jeopardize the effectiveness, safety, and success of your medical products. Get the tools you need to maintain this key element of your process, determine which data integrity concepts best apply to your organization, and develop a meaningful risk management strategy for your team.

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