Our approach to providing validation services is adaptable to each client's needs and company procedures, and is applicable to any computer system validation project. We can provide your organization with the following services:

Project Consulting

  Validation Project Management

  Document Templates for Validation Deliverables

  Preparation of Validation Plans and/or Protocols

  User Requirements Specification Development

  Validation Test Script & Test Data Creation

  Test Script Execution & Analysis of Results

  Traceability Analysis & Traceability Matrix Preparation

  Preparation of Validation Summary Reports

  Evaluation/Assessment of Validation Documents

  Evaluation and/or Development of SOPs

  Risk Management Activities & Documentation
    Preparation

  Part 11 Gap Analysis & Remediation Plan Development

  Prospective & Retrospective Validation Projects

  On-Site Training & Speaking Engagements

  Performing Audits of Vendors providing Automated
    Systems

  Auditing the Computer Validation Practices of Service
    Providers (CROs, Analytical Labs, Hosting Facilities)

  Performing PDA Supplier Audits for the Audit Repository
    Center (ARC)

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Latest News…

February 2011:
Validation Associates, Inc. (VAI) has scheduled its spring and fall public seminar series May 02-06, 2011 and November 14-18, 2011; the sessions will be held in Princeton, NJ.

December 2010:
Validation Associates, Inc. (VAI) is pleased to announce that, for the 6th consecutive year, it has been certified as a Women’s Business Enterprise (WBE) by the Women’s Business Enterprise National Council (WBENC) and the Women’s Business Enterprise Council of PA-DE-sNJ.

April 2010:
Validation Associates, Inc. (VAI) celebrates 15 years in business.

February 2009:
Mary Lou Cardie and Nancy Tucker prepared/presented "Risk Management Applied to Computerized System Upgrades" at the February 12 Oracle AERS User Focus Group meeting.