Using Macros and Spreadsheets in a Regulated Environment

• Date: November 03, 2009

Spreadsheets are tools that simulate paper worksheets. Macro is a pattern that specifies mapping of input sequence to the output sequence in a pre-defined procedure. Macros also enable automation of repeat actions. Macros and spreadsheets are used in conjunction in regulated environments. Spreadsheet programs are very generic and their use in regulated environs requires preventive actions to avoid mitigate the risk due to erroneous outputs. Therefore, electronic records generated using spreadsheets must comply with 21 CFR Part 11.

The primary requirements of 21 CFR Part 11 are:

• Dedicated software for use in regulated environment
• Evaluate software add-ons that enable existing software to comply
• Bring in compliance requirements as built-in functions in the development phase

What are the current compliance problems? What it takes to bring spreadsheet applications under the purview of compliance?

• use of validated software and computer systems
• user-independent, computer-generated, time-stamped audit trails
• system and data security, data integrity, and confidentiality through limited authorized system access
• binding electronic or handwritten signatures to electronic records
• secure retention of accurate and complete electronic records

Commercially available software are generic, hence achieving compliance can be done by having: