Data Integrity is a critical element of any pharmaceutical, biotech, medical device or CDMO’s strategy. In part 1 of this 2-part blog series, Verista Regulatory and Auditing subject matter experts discuss the importance of data integrity and why it’s a concern. In part 2, they’ll discuss issues with it and how AI (artificial intelligence) can help.
Q: Why are regulatory agencies and customers concerned about data integrity?
A: Regulatory agencies and customers approach data integrity from their own perspective but the major areas of concern around data integrity include:
- Patient Safety: Accurate and reliable information in agency databases, such as the National Drug Code (NDC), Global Unique Device Identification Database (GUDID), and EU equivalents, is crucial for patient safety. Healthcare professionals rely on these databases to accurately identify medications and medical devices, ensure proper usage, and avoid errors that could harm patients. Inaccurate or incomplete data could lead to medication errors, adverse reactions, or ineffective treatments.
- Product Identification: The National Drug Code Database (NDC) and Global Unique Device Identification Database (GUDID) serve as reference catalogs for identifying pharmaceutical products and medical devices. If the data is incorrect, outdated, or inconsistent, it can lead to confusion, misidentification, and potentially the wrong product being used or prescribed. Data integrity is essential for ensuring accurate product identification throughout the supply chain and healthcare settings.
- Supply Chain Management: Data integrity in agency databases, such as the National Drug Code (NDC), Global Unique Device Identification Database (GUDID), and EU equivalents, is critical for effective supply chain management. Manufacturers, distributors, and regulators rely on accurate information to track and trace products, monitor inventory, prevent counterfeiting, and ensure product quality and authenticity. Any discrepancies or inaccuracies in the data can disrupt the supply chain and compromise patient safety.
- Regulatory Compliance: Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), rely on accurate data to monitor and regulate pharmaceutical products and medical devices. Data integrity ensures compliance with regulatory requirements, such as labeling standards, product recalls, adverse event reporting, and post-market surveillance. Inaccurate data can hinder regulatory oversight and compromise patient health.
- Transparency and Accountability: Data integrity promotes transparency and accountability within the healthcare industry. Accurate information allows stakeholders, including regulatory agencies and customers, to make informed decisions, conduct research, evaluate safety and efficacy, and hold manufacturers accountable for their products. Inaccurate or incomplete data undermines transparency and erodes trust in the system.
Q: What areas across the product lifecycle do regulatory authorities require organizations to document and track good data integrity practices and why?
A: Data integrity is an important aspect from product concept to product launch and beyond. Regulatory agency guidelines mandate organizations to develop processes and submit documentation across the product lifecycle in the following areas:
- Good Manufacturing Practices (GMP): GMP regulations require life sciences companies to establish and maintain systems that ensure the quality, safety, and efficacy of their products. Data integrity plays a crucial role in demonstrating compliance with GMP standards. Regulatory agencies expect accurate and reliable data in areas such as manufacturing, testing, quality control, and documentation.
- Regulatory Submissions: Life sciences companies are required to submit various regulatory documents and data to obtain approvals, licenses, or authorizations for their products. These submissions need to be accurate, complete, and supported by reliable data. Regulatory agencies scrutinize the data integrity of these submissions to ensure the safety and effectiveness of the products.
- Clinical Trials: Clinical trial data integrity is of utmost importance as it forms the basis for evaluating the safety and efficacy of investigational products. Regulatory authorities require complete, accurate, and verifiable data to assess the results of clinical trials and make informed decisions regarding the approval of new drugs or medical devices.
- Data Management and Documentation: Life sciences companies are expected to have robust data management systems and practices in place. This includes ensuring data is captured, recorded, stored and reported accurately and securely. Documentation related to manufacturing processes, quality control, adverse event reporting, and regulatory submissions must be maintained with proper data integrity controls.
- Audit and Inspections: Regulatory authorities conduct audits and inspections of life sciences companies to assess their compliance with regulations. Data integrity is a significant focus during these inspections. Authorities may review data handling processes, electronic systems, data security measures, and the overall culture of data integrity within the organization.
- Data Fraud and Misconduct: Regulatory concerns arise when there are instances of data fraud or misconduct within the life sciences industry. Manipulating or falsifying data undermines the credibility of research, clinical trials, and regulatory submissions. Regulatory agencies strive to identify and address such instances to maintain public trust and ensure patient safety.
- Global Harmonization: As life sciences companies operate in a global marketplace, regulatory agencies aim for the harmonization of standards and expectations. Ensuring consistent data practices across different regions helps facilitate international collaboration, regulatory alignment, and the exchange of reliable information.
In part 2 of this blog, Verista Regulatory and Auditing subject matter experts discuss issues with data integrity along with the pros and cons of AI (artificial intelligence). If you would like to speak with one of our experts, contact us here.
