Ludwig Huber


21 CFR Part 11 - Requirements and New Scope

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

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.

Getting a Handle on Access Security for 21 CFR Part 11

How can you be sure only authorized users are entering data into your system? Is your electronic signature yours alone? Are you sure operators can?t 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.

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

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.

Part 11 Is Not Going Away: The New Electronic Records Draft Guidance

by Wolfgang Winter, Agilent Technologies GmbH and Ludwig Huber, Agilent Technologies GmbH The rules for electronic records and signatures still remain in effect. The change means that companies must now justify their decisions on whether or not to implement specific electronic controls with documented risk assessments and considerations of the record requirements detailed in the corresponding predicate rule.

Qualification of Network Components and Validation of Networked Systems

by Ludwig Huber at Agilent Technologies GmbH and Rory Budihandojo To comply with 21 CFR Part 11, your networked systems require the same validation and qualification steps as those for a single computer. Shared servers and multiple access also add requirements that are unique to networks. Italicized words in this article are defined in the "The Glossaryy" on the last page of the online version.