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21 CFR Part 11

Standards and regulations

Validation Plan

Qualifications

LIMS

User Requirements Specification URS

System selection

Vendor audits

IT project organization

Live system organization 

 



Segalstad Consulting AS
PO Box 15 Kjelsås, 0411 Oslo, Norway * Tel: +47 2223 8005 * Fax: +47 2223 8581 * Email: Siri@Segalstad.com * 

Web: www.LIMSconsultant.com    www.segalstad.com