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Validation Process

This document outlines the requirements for identifying validation requirements for equipment or processes. It instructs to: 1) Identify the equipment/process to be validated and associated SOPs. 2) Identify the reason for validation including if it's for a repair, relocation, modification or new change. 3) Identify any limitations/restrictions to the validation plan.

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Mau Tau
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114 views1 page

Validation Process

This document outlines the requirements for identifying validation requirements for equipment or processes. It instructs to: 1) Identify the equipment/process to be validated and associated SOPs. 2) Identify the reason for validation including if it's for a repair, relocation, modification or new change. 3) Identify any limitations/restrictions to the validation plan.

Uploaded by

Mau Tau
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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IDENTIFYING VALIDATION Identify and list the following:

• equipment/process to be validated,
REQUIREMENTS including associated SOPs that govern the
process
Verify change control assessment was
• reason for validation, including whether the
performed and determined that
equipment or process is a repair,
validation is necessary
relocation, modification, or new change
(purpose)
• any limitations/restrictions to validation plan
(scope)

Identify/list pertinent sections of


operator's manual (include version
Manufacturer- Verify facility has the
identifier) & other manufacturer
provided most recent version
Yes documentation to identify
documents? that will be
operational or environmental
implemented
parameters for installation,
operation, or repair.
No

Identify/list final process


Obtain manufacturer- output or final product
provided documents requirements for equipment
or process

Identify/list specific
Designate each If non-critical,
requirements for equipment/
requirement as provide
process in manufacturer,
critical or non- rationale for
CFR, or Company
critical designation
documentation

Review manufacturer
Identify/list protocols
Manufacturer- provided documentation
and work instructions
perform IQ? Yes for adequacy to
manufacturer will
demonstrate proper
follow
installation and set up
No

List any known Designate requirements as


Identify/list requirements
• design defects critical or non-critical.
not met by manufacturer's
• operational errors Provide rationale for non-
documentation
• process deficiencies critical

List all needed to complete validation:


• equipment, include application in process
• ancillary supplies
• manuals and/or procedures

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