Experience

CRM/SFA/PDMA Experience
RPCI and its principals have been involved in computer system validation projects in the FDA regulated industry for over 14 years. Initial involvement with CRM systems was in 1996, working with laptop-based/PDA Sales Force Automation systems, and Sample Reconciliation Systems, to ensure compliance to the Pharmaceutical Drug Marketing Act (PDMA). In 1997, 21 CFR Part 11 became an integral part of the compliance of SFA/CRM systems, and RPCI’s principals were involved right from inception. Working knowledge of FDA regulations pertaining to electronic data storage, handling, and validation has led its principals to speak at conferences on the topics of CRM validation, 21 CFR Part 11 compliance and PDMA regulations (ISPE 2004, 21 CFR Part 11, PDMA Sharing Conference, 2001). Some of our key accomplishments are listed below:

• PDMA Sharing Conference - Led a group and SFA workshop, Miami, FL, Nov, 2001
   
• Completed the implementation and validation of a multi-million dollar Siebel system within 5 months
   
• Customer Relationship Management Systems (includes Sales Force Automation (SFA) Systems and Sample Reconciliation Systems): Siebel, IMS, Dendrite, Sample Guardian

Industry Experience
The principals of RPCI have performed validation of SFA/CRM and Sample Reconciliation Systems for many clients, including Hoffman-LaRoche, Berlex, Ventiv, Whitehall-Robins, Wyeth,and Glaxo. Many of the clients were implementing a system for the first time and relied on RPCI’s principals for guidance.


Project Management Experience:
RPCI has extensive project management experience. Its principals have been in management roles since the early 1990’s. Affiliates selected also have resources that are strong in management. RPCI is a current member of the Project Management Institute (PMI). Successful projects that have been managed include Wyeth Siebel implementation, Whitehall-Robins SFA implementation, Sample Reconciliation System projects for multiple clients, including Hoffmann-La Roche, LIMS implementation and validation for Merck, Ethicon, Pasteur Merieux Connaught (now Aventis), Alcon Laboratories, Organon, and Stiefel Laboratories. In addition RPCI has managed ERP projects and other types of projects.

For more information Contact Us

Top