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Username Post: coding adverse events
John
John Cuspilich, Sr. Consultant
Posts 229
John 		05-24-07 05:47 AM - Post#4001    

Yes, most definitely,

  1. You must ensure that the custom system has met validation and compliance requirements in accordance:
    1. 21 CFR Part 11
    2. General Principle of Computer System Validation
    3. Computerized Systems Used In Clinical Trials 2004
    4. Computerized Systems Used In Instigations 2007
    5. ICH E6
  2. Procedural controls are properly in place, i.e.
    1. SOPs on Data Updates on master files, i.e. database, external dictionaries, etc…
    2. SOPs on Change Controls in existing records
    3. Validity of dictionary terms and acceptability of use
    4. QA/QC Procedures for conducting reviews and qualifications of terms and use of
Sincerely,
John F. Cuspilich, Sr. Consultant RA/QA
FDA.COM
The Auditing Group, Inc.
GMP Publications, Inc.
jcuspilich@auditing.com
jcuspilich@fda.com
856-596-2333 - 866-GXPNews


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