Clark J. Kashmaier
                                                           ERP Validation Overview

Validation Plan
As the validation process takes place over a period of time, a validation plan is written to
describe the elements of the process, including a description of each protocol as well as the
  • Purpose
  • Scope, which includes any and all documentation used in the ERP-selection process—
    this is the basis by which the OQ customization process beings
  • Functional System Design
  • Background, including general information concerning the various Expandable elements
  • References—appropriate external (regulatory) and internal references
  • Definitions
  • Responsibilities
  • Risk Analysis
  • Validation Approach (both an overview as well as plan to comply with 21 CFR Part 11,
    Section 10) and including how re-validation is to be performed when system upgrades
    are to be performed

Installation Qualification
  • Establishing by objective evidence that all key aspects of equipment and software
    installation adhere to the manufacturer’s requirements.  
  • Equipment identification, utility requirements and major component specifications are
  • The requirements for qualification include:
  • System location and its security controls verification
  • Hardware installation and component verification
  • Software installation and component verification
  • System documentation verification.
  • Software is installed under protocol-control, typically by an employee of the Software
  • A written report is completed after the IQ is executed

Operational Qualification
  • Establishing by objective evidence parameters that result in an operational product that
    meets all predetermined software requirements.  The requirements for this qualification
    are: startup & shutdown, backup & restore, access & security, displays & reports,
    messages & alarms, data storage & access, data edits & audit trails and system interfaces
    & data exchange.
  • The protocol is fully customized to emulate how the Expandable client expects to use the
  • All modules used by the client are functionally tested
  • Other non-functional tests are performed, including those related to 21 CFR Part 11
  • The customized protocol is written and executed (remotely)
  • Once the protocol is executed (and all elements pass), the system is released for
    production (client can go “live”)
  • A written report is completed by after the OQ is executed

Performance Qualification
  • Establishing by objective evidence that the process, under anticipated conditions,
    including worst-case conditions, consistently produces a result that meets all
    predetermined requirements while operating in an environment specific to a client
    during a period of 30 days of operation.  The PQ process shall be used as a means to
    identify any system (hardware or software) or training issues (which typically are
    resolved through a CAPA system).
  • A PQ report is written upon the completion of the 30 days of use

A Final Report is written summarizing the findings of the various elements of the project as
well as findings related to 21 CFR Part 11 compliance.