Enterprise Data Warehouses, FDA Regulations and Bad Data
In the U.S., pharmaceutical firms and medical device manufacturers must meet electronic record-keeping regulations set by the Food and Drug Administration (FDA). The regulation is Title 21 CFR Part 11, commonly known as Part 11.
Part 11 requires regulated firms to implement controls for software and systems involved in processing many forms of data as part of business operations and product development.
Enterprise data warehouses are used by the pharmaceutical and medical device industries for storing data covered by Part 11 (for example, Safety Data and Clinical Study project data). QuerySurge, the only test tool designed specifically for automating the testing of data warehouses and the ETL process, has been effective in testing data warehouses used by Part 11-governed companies. The purpose of QuerySurge is to assure that your warehouse is not populated with bad data.
In industry surveys, bad data has been found in every database and data warehouse studied and is estimated to cost firms on average $8.2 million annually, according to analyst firm Gartner. Most firms test far less than 10% of their data, leaving at risk the rest of the data they are using for critical audits and compliance reporting. QuerySurge can test up to 100% of your data and help assure your organization that this critical information is accurate.
QuerySurge not only helps in eliminating bad data, but is also designed to support Part 11 compliance.
Data Warehousing & Pharma: How to Find Bad Data while Meeting Regulatory Requirements
Below are 8 examples of how QuerySurge assists pharmaceutical firms in support of Part 11.
tracks test history (user, date, each test version)
provides reporting on test version history for convenient auditing
supports tracking of execution-cycle deviations from approved tests
records all test execution owners by name and date
delivers auditable results reporting of test cycles
persists all test outcomes and test data for post-facto review or audit
offers a read-only user type for reviewing test assets
supports off-database archiving of results (for future restore) for effective long-term results data management
Read about a company that embarked on a data migration testing project to ensure that over 300,000 records were transformed and loaded from an older Siebel source system to a newer Siebel system. The QA team was able to validate 100% of the data throughout the process.