The purpose of this article is to review the solution to four (4) common challenges when using spreadsheets to meet GxP quality requirements. These challenges are:

1) The effort required to print, sign, securely store and retrieve completed worksheets.
2) Compromised file security through password sharing
3) Tracking changes made to worksheets
4) Maintaining workbook integrity, post spreadsheet validation

Continue reading “Overcoming 4 Challenges to the Use of GxP Compliant Spreadsheets”

Executive Summary

The United States Food and Drug Administration’s (FDA) modern regulatory function started with the 1906 Pure Food and Drugs Act and continues through 21 CFR Part 11, which details the criteria for reliable electronic records and signatures as used in pharmaceutical and medical device manufacturers, bio tech companies, research labs and clinical trials. Commonly referred to as Part 11, the regulation calls for controls such as system validations, audits, audit trails, documentation and electronic signatures to make certain predicate rules created for paper documentation can be applied to electronic documents as a means of ensuring the accuracy, reliability, integrity, availability, and authenticity of required records. Continue reading “Spreadsheet Life Cycle Management for Part 11 Compliance”