Clark J. Kashmaier 971-217-5558 email@example.com
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 following:
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
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
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 documented.
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 Manufacturer
A written report is completed after the IQ is executed
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 software
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
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.