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| Clark J. Kashmaier 971-217-5558 clark@kashmaier.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:
Installation Qualification
Operational Qualification
Performance Qualification
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.
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:
- 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
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
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
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
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.