Ludwig Huber

Articles

Spreadsheet calculations are popular in all kinds of businesses. A macro is a set of commands that can be embedded in a document to add functionality to standard programs and to automated processes.

Using Macros and Spreadsheets in a Regulated Environment

Networks are part of the compliance picture. Recent FDA warning letters show the agency considers network monitoring and qualification a necessary part of maintaining the security and integrity of electronic records.

Qualifying Network Infrastructure - A Risk-Based Approach

The FDA rule on electronic signatures and electronic records was issued in 1997, but the details of implementation are still being debated. The 2003 FDA guidance redefines the scope of 21 CFR Part 11. Understanding which records now fall under the scope of the rule can help you begin implementing your compliance plan.

21 CFR Part 11 - Requirements and New Scope

Protecting the integrity of data is a challenge of 21 CFR Part 11 compliance. Integrity requires records to be complete, intact, and maintained in their original context ? associated with the procedures which were used to create the data.

Author | Ludwig Huber