Articles by Ludwig Huber - BioPharm International

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Articles by Ludwig Huber

Using Macros and Spreadsheets in a Regulated Environment

Records produced by macros and spreadsheet calculations must comply with 21 CFR Part 11. As spreadsheet programs are not designed for regulated environments, special steps must be taken to maintain compliance.
Apr 5, 2004

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.

21 CFR Part 11 - Requirements and New Scope

Feb 15, 2004

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.

Data Integrity for Electronic Records According to 21 CFR Part 11

Feb 15, 2004

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 ó associated with the procedures which were used to create the data.

Qualifying Network Infrastructure - A Risk-Based Approach

Feb 15, 2004

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.

Level-4 Instrument Control - Why It's Relevant for Part 11

Feb 15, 2004

Bringing different laboratory instruments into compliance takes planning. The key strengths and weaknesses of different levels of control and feedback for analytical instruments and data transfer systems are highlighted in this article.

Getting a Handle on Access Security for 21 CFR Part 11

Feb 15, 2004

How can you be sure only authorized users are entering data into your system? Is your electronic signature yours alone? Are you sure operators canít invalidate your data? Is your company in compliance with FDA data security regulations? The second article in our series on 21 CFR Part 11 will help you answer these questions.

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