Data Integrity for Drug and Device Manufacturers: Avoiding Breaches and Closing Gaps
Data integrity has taken center stage in new ways and accuracy is vital. Mistakes will break you. Even the smallest, most unintentional error in your recordkeeping and documentation can cast doubt on all your data, which can lead to stoppage, delays and regulatory enforcement.
The Data Integrity for Drug and Device Manufacturers: Avoiding Breaches and Closing Gaps report is your GPS for compliance. It explains what data integrity is, how to protect it, how to spot problems and what the FDA expects. It also shows you how to prove the strength of your data, even during a virtual FDA inspection. All so you can stay compliant and get to market more quickly.
Data integrity isn’t just a method or concept, it’s a mindset. A corporate culture built on data integrity includes risk-based oversight and prevention systems, as well as recruiting, training and retaining employees who will work responsibly to ensure the integrity of company data.
Data Integrity for Drug and Device Manufacturers addresses the five leading solutions for data integrity issues. In addition to creating a corporate quality culture, they are: developing corporate leadership that’s engaged in quality (and is visible); investigating and addressing problems under a top-notch corrective and preventive action (CAPA) system; ensuring that employees responsible for entering, modifying, maintaining, reporting and reviewing critical data have the right skill sets and dedication to high quality and ethical standards; and implementing performance management that’s practical, balanced and effective.
The report explains the top 10 data integrity traps you must sidestep to ensure compliance. These include document control, electronic data systems, analytical documentation and materials management. It will enable you to:
- Create a risk-based approach to detecting data integrity problems
- Identify and mitigate factors contributing to the loss of data integrity
- Use the Compliance Maturing Curve
- Define a data integrity audit strategy
- Identify and implement the four essential characteristics of a culture of quality
Plus, the agency’s guidance on data integrity and compliance with current good manufacturing practices (cGMPs), included in the appendix, answers manufacturers’ most common questions and lets you know exactly what the FDA means by data integrity.
Data Integrity for Drug and Device Manufacturers: Avoiding Breaches and Closing Gaps is the solution you need to ensure data integrity and get your products to market faster. Will your data integrity hold up?
About the Contributors
Marie McDonald is Vice President of Consulting Services at IQVIA. She has more than15 years’ experience in the life sciences industry, serving as a consulting business partner for biopharmaceutical and medical device companies. Ms. McDonald has worked on consulting engagements that span strategy development, program and project planning, process design, quality systems improvement, training and change management, as well as regulatory remediation and compliance improvement.
Glen Potvin, Principal at Splash Consulting, has more than 25 years’ experience in delivering results through structured analysis, creative problem solving, strategy development and focused project management. He has led a portfolio of successful business improvement programs within top pharmaceutical and medical device companies, delivering transformational results through teamwork, structured analysis, creative problem solving, strategy development and focused project management.
Who Will Benefit
- QA/QC staff
- Regulatory affairs personnel
- Vendor/supplier management
- Inspection managers
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Marie McDonald and Glen Potvin
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