In their Data Integrity Report1, Deloitte experts express that “The integrity of data generated by highly regulated life sciences companies is critical, because properly recorded information is the basis for manufacturers to assure product quality, safety and efficacy prior to product approvals and subsequently placing them onto the markets for human use. Data Integrity is also important for quality control procedures during manufacturing to ensure patient safety.”
As global regulatory focus on Data Integrity increases, companies that fail to comply may face penalties ranging from public warning letters to criminal charges. Additionally, product removal from the marketplace can occur. In recent years, there has been a significant increase in the number and type of issues related to data practices, including unauthorized data access, a lack of enabled audit trails, and accidental and intentional falsification of records.
According to RAPS’ publication Regulatory Focus2 “The number of warnings letters with data integrity problems has increased over the past three years, from 47% of the warning letters issued in FY (Fiscal Year) 2019, to 51% in FY 2020 to 65% in FY 2021.”
The FDA in the U.S. and its European counterpart are making demands in the interest of patient safety. In this post, we’ll focus on the concept of ALCOA+ introduced by the FDA. You’ll discover how Minitab Solutions can help to solidify good practices that will enrich the quality of data, allowing companies to make strategic decisions backed by analytics and accurate data.
ALCOA refers to data being Attributable, Legible, Contemporaneous, Original and Accurate
Do you know who has accessed or used your data?
Businesses need to be able to monitor who recorded and/or processed data, either manually or electronically.
The data source should be tracked throughout its lifecycle from collection through studies, analytical runs, and test systems.
Minitab’s platform for data integration, automation, monitoring & analytical reports – Minitab Connect – offers audit trail capability. The audit trail ensures tracking of all activities run with data: collection, aggregation, processing, compilation, graphical outputs, analytical reports and dashboards. Companies can always provide the details of when and where data was touched, and by whom.
Is your data accessible and readable anytime, anywhere?
After it’s been recorded, you should be able to view and use data permanently.
Was data recorded when the activity occurred?
Data should be recorded both during generation and processing.
The audit trail capability of Minitab Connect ensures the possibility to record data anytime accurately and efficiently.
Is the data certified and true?
Data should be stored in its unaltered, raw state.
Is your data error-free?
Data must reflect its real actual value; it should be true.
A branch of statistics, Measurement System Analysis, lets you quickly assess and improve your measurement system so you can be sure you’re collecting data that is accurate and precise.
If you do not analyze your measurement system, you’re much more likely to add variation and inconsistency to your data that could cloud your analysis.
The Measurement System Analysis (MSA) menu in Minitab Statistical Software can help you check whether the operators and measuring devices provide accurate, consistent, and precise information.
When gathering quantitative data, Gage Repeatability and Reproducibility (R&R) analysis confirms that instruments and operators are measuring parts consistently.
If you’re grading parts or identifying defects, an Attribute Agreement Analysis verifies that different evaluators are making judgments consistent with each other and with established standards.
Pharmaceutical companies and organizations in the health sector must apply more complete and complex techniques, mainly for process validation, measurement imprecision, and bias. To meet these demands, it is good practice to follow 'critical checks'. Read our Blog to learn more >
More recommendations have been released to improve data integrity. There are additional guiding principles represented by the plus sign of ALCOA +, including:
Making sure records exist for the entire period, and that they are readable.
Data should be sufficiently detailed.
Recording of data should be well-documented.
Please get in touch with our team to find out how you can improve the integrity of your data to ensure compliance with ALCOA+ recommendations using Minitab Solutions. Talk to Minitab >
If you’d like to learn whether Minitab has been validated by the U.S. Food and Drug Administration (FDA) for use in the food, healthcare, pharmaceutical and medical device industries, please read our Blog "Need to Validate Minitab per FDA Guidelines? Get Minitab's Validation Kit" >