Sunil K. Gupta, Principal Consultant

SAS Certified Base Professional

Simi Valley, CA

(805) 577-8877, Sunil@GuptaProgramming.com

TRAINING, DEVELOPMENT, REVIEW, or PERFORM any of the following services for Biotechs:

21 CFR Part 11 Compliance Review
(Electronic Records and Electronic IDs)

SOPs - Development and Review

Develop and Perform Validation Protocols:

(IQ) Installation Qualification
(OQ) Operational Qualification
(PQ) Performance Qualification

Issues in Software Development Life Cycle

Program documentation and validation for FDA submission: Tables, Lists, and Graphs

System Process Design

Software Application Requirements Documentation

 

"Put the experience of over seven successful FDA submissions to work for you!"- Sunil Gupta

 

Copyright 2011, Gupta Programming. All Rights Reserved