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 How to Implement 21 CFR Part 11 Regulation and its Guidances

Approximate Time: 4 hours

Who Should Attend:

This course explains how to apply the electronic records and signatures regulation in a real world setting.  It is ideal for all personnel that interact with electronic systems in an FDA regulated environment, including QA, QC, Regulatory, Manufacturing, Laboratory Services, Process Development, and all of Operations support.

Course Description: 

This course explains all aspects of the Part 11 regulation and gives an overview of the associated Guidance Documents. It contains many examples of how the regulation can be applied using typical industry scenarios.  It also includes many quotes from FDA and FDA issued Warning Letters to show how the regulation is being applied by regulatory agencies.  Risk based approaches to Part 11 are also included.  The changes to Part 11 announced in February of 2003 have been incorporated into this training session. 


Introduction to Part 11 Requirements


Systems Covered by Part 11


Electronic Records Requirements


Additional Open Systems Requirements


Additional Electronic Signatures Requirements


Controls for Identification Codes and Passwords


FDA Guidance Document Recommendations


Examples of Part 11 Implementation in the Real World, including 

Formal Part 11 Assessment of all existing systems 


Change Control


SOPs for security control 


SOPs for ensuring personnel accountability


SOPs for to fill in the gaps when systems are not fully compliant


Electronic Systems Investigations


Specifying Part 11 requirements when procuring/designing new systems 


Spreadsheet control, validation, and security 


IT is now GMP


Trends for Compliance

For "Real World" situations, examples from the following systems are incorporated:

bulletOff-The-Shelf and Custom Process Monitoring and Control System (e.g. chromatography skid, utility and building monitoring) 
bulletSpreadsheets (e.g. Environmental Monitoring data) 
bulletCustom Database (e.g. investigations tracking) 


bulletAnalytical Laboratories 
bulletOff-The-Shelf and Custom database system (e.g. sample and results tracking) 
bulletLab Instruments (e.g. certain HPLC) 
bulletSpreadsheets (e.g. results calculation) 


bulletProcess Development 
bulletCustom Database (e.g. process development database) 
bulletSpreadsheets (e.g. critical parameter trending)


NOTE:  A 2 hour version, abbreviated version of this course is also available.  All the basics of the regulation and the guidance documents are covered, but with fewer "real world" examples.


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FDA on Electronic Records

The theme of the regulations is that part of what makes electronic signatures trustworthy, are the underlying records themselves. The actual records are also important. It is just as important to have those records be trustworthy regardless of whether the records are electronically signed or not. These regulations are really for electronic records AND electronic signatures.

Paul Motise
SQA CVIC Meeting
June 1997

Copyright 2003 Compliance Net, Inc.

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