Operational qualification template

Process validation protocol – Operational qualification template

About the Process validation protocol – Operational qualification template

An Operational Qualification template, also known as an Operational Qualification, is used to complete the process validation protocol by collecting all required data such as calibration equipment, training records and user manuals, and displaying the results of checkpoints, alarms and output data. Use this template to define specific plant/system challenges such as standard conditions and worst-case situations for your validation plan. Lab managers can also take advantage of a customizable Tablet Compression Checklist SOP to ensure that lab personnel take the right steps when using the tablet press.

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Process Validation Protocol - Operational Qualification Template

Operational Qualification Protocol

Goal:

Scope of the Operational Qualification Protocol:

Responsibility and responsible person/people/team(s)

Materials, Equipment, Documents

Preparation

List of Calibration Devices/Tools Required

Calibration Process

Calibration Time

Apparatus/Instrument

Document Validation

SOP Name and Number

File Location

QA/QC Approval Date

Training Reports

Name of the emplyee

Select Date and Time:

Course on SOP#

Equipment

Their Make and Model

Is a handbook accessible to everyone?

Results

Control Point(s) and Alarm(s)

Control Point(s) /Alarm(s)

Result

Date

Outputs

Explain the output

Result

Date

Calibration of Equipment/System

Explain the Calibration SOP

Result

Date

Specific Challenge of the Equipment or System

Test in usual conditions

Test of worst case szenario:

Completion

Operational qualification results:

Conclusions:

Name and signature of the protocol author :

Departmental approval by (name and signature):

Quality assurance approval by (name and signature):

This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.