Why Data Integrity Is So Important
Implications of Increased FDA Oversight & Guidance
While data integrity has always been an important component of the pharmaceutical and clinical cosmetic sectors, it seems to be more garnering more than its fair share of attention in recent years. Data integrity system and process quality has become a heavy hitting indicator of company profitability in light of increasing scrutinization by regulatory agencies such as the Food & Drug Administration (FDA).
As data integrity becomes a more complicated challenge with the increasing dependence on digital record keeping and tracking, pharmaceutical manufacturers are working hard to close up any gaps in their data integrity compliance systems to avoid a seemingly endless barrage of warning letters that have been issued by the FDA to many others in the industry.
Rise in Warnings
The number of warning letters issued by the FDA’s Center for Drug Evaluation and Research (CDER) rose by 35% in 2017, reaching 85 letters total compared to 2016 numbers (63) and 2015 (44). These warning letters targeted specific data integrity problems that resulted in FDA Current Good Manufacturing Practices (CGMP) violations.
Whether the uptick in warning letters and other methods of reprimand are a product of poor data integrity practices within the pharmaceutical industry, or just a reflection of increased jurisdiction by the FDA as a result of recent legislation (The Drug Quality & Security Act of 2013) that strengthens their authority, manufacturers have responded by reviewing their own data integrity practices.
Government Help
For the government’s part in response to this increased regulatory action, most often in the form of warning letters (but also through import alerts and consent decrees), in 2017 the FDA published recommendations for best data integrity practices to help pharmaceutical and other healthcare sector companies maintain full awareness of FDA expectations.
Data Integrity Suppliers
Also working hard to improve their game are companies providing manufacturers with digital solutions, such as automated smart device calibration software, record keeping utilities, and chain of custody trackers to provide their customers with products that feature the utmost in compliance with data integrity regulations.
CGMPs
FDA’s formal regulations regarding the operation of manufacturing companies come in the form of CGMPs, or Current Good Manufacturing Practices. Under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) the CGMPs require pharmaceutical companies to
comply with best data integrity practices, which are listed by the FDA under subsections of the FD&C. However, considerable flexibility is given to each drug and clinical cosmetic manufacturer in the implementation of these regulations:
- Backup data are exact and complete and secure from alteration, inadvertent erasures, or loss
- Data is stored in a way that keeps it protected from deterioration or loss
- Activities are documented contemporaneously
- Labs are implementing scientifically sound controls
- Records stored are original, true copies, or certified reproductions
- All information is complete: test data, record of test performance, observations, etc.
Data Integrity Defined
The FDA defines data integrity as “the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA),” according to the FDA guidelines.
Attributable
having a record of who performed the action or the source data
Legible
all records are readable and traceable for the lifetime of the product
Contemporaneous
all data be recorded in real time/when the event occured
Original
presence of original or certified true copies.
Accurate
records are completely documented (repeats, analysis, errors & edits)
Future Implications
While warning letters are still on the rise, the current Trump administration has vowed to roll back federal regulatory oversight. While less scrutiny may be on the horizon, identifying and employing data integrity best practices is still in the best interest of any pharmaceutical or clinical cosmetic manufacturer’s bottom line.
https://www.biopharmadive.com/news/fda-gottlieb-trump-regulation-guidance-manufacturing/517589/
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM518522.pdf
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf
https://www.fda.gov/downloads/drugs/guidances/ucm495891.pdf