Month: February 2018

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”