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21 CFR Part 11 Compliance for Spreadsheets

Since the FDA’s Data Integrity guidance came out in April 2016, there has been a lot of interest on the topic. Indeed, the number of warning letters for drug GMPs increased by 12% in FY2017 as compared to the previous year. 65% of these warning letters cited data integrity violations.

In a world awash with data, where does one start to improve data integrity? From an IT perspective, data is generally classified as:

  • Structured data, that normally resides in a relational database such as SQL or Oracle. Enterprise applications such as ERP, MES and LIMS typically store their data in such relational databases and are examples of structured data.
  • Unstructured data, that refers to files residing on users’ local machines or network drives. Common examples of unstructured data include spreadsheets, Word/PDF documents, drawings, instrument lab or other raw data files in CSV or TXT format.

Data integrity assurance requires a number of components that include, but are not limited to, security, audit trails and electronic signatures. Applying a risk-based approach to data would lead to the following general conclusions: Continue reading “21 CFR Part 11 Compliance for Spreadsheets”


Sustainable Business Practice leading to Quality and Compliance Enhancements

Companies that use spreadsheets for business process that involve GCP, GLP or GMP outcomes often look to tighten up good practice by focusing on the most immediate
problem(s) at hand. Typically that involves one or more of the following processes:

1. Validate of the spreadsheet
2. Verify that the use of the spreadsheet complies with Predicate rules and 21 CFR Part 11 requirements for security, audit trail and e-Signature sign offs
3. Validate the application providing the controls

All three processes are important and play a critical role in the proper use of spreadsheets in labs, clinical trials, research or manufacturing and in meeting requirements of 21 CFR Part 11. Continue reading “Sustainable Business Practice leading to Quality and Compliance Enhancements”