Overview of Validation Documents and

Projects
Validation is the documented process of demonstrating that a system or process meets a defined set
of requirements. There are a common set of validation documents used to provide this evidence. A
validation project usually follows this process:

 Validation Planning – The decision is made to validate the system. A project lead is identified,
and validation resources are gathered.

 Requirement Gathering – System Requirements are identified. Requirements are documented

in the appropriate specifications. Specification documents are reviewed and approved.

 System Testing – Testing Protocols are written, reviewed, and approved. The protocol is

executed to document that the system meets all requirements.

 System Release – The Summary Report is written and system is released to the end-users for
use.

 Change Control – If changes need to be made after validation is complete, Change Control
ensures that the system changes does not affect the system in unexpected ways.

General Validation Issues

 Validation Terminology

 Frequently Asked Questions about Validation

 Risk Assessment

 Testing Deviations

 Change Control for Validated Systems

Validation Documents: Requirements and

Design Specifications
 User Requirement Specification

 Functional Requirements

 Design Specification
Validation Documents: Test Plans/Test
Protocols
 Test Plans/Test Protocols

 Installation Qualification

 Operational Qualification

 Performance Qualification

Design Qualification (DQ) Documented verification of the design of equipment and manufacturing
facilities. Installation Qualification (IQ) Documented verification that equipment is installed and
operating properly. Operational Qualification (OQ) Documented verification of equipment or system
performance in the target operating range. Process Performance Qualification (PQ) Documented
verification that equipment or systems operate as expected under routine production conditions. The
operation is reproducible, reliable and in a state of control. Process / Product Validation Quality
Square Industry

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Process Performance Qualification (PQ)

Process / Product Validation

https://www.slideshare.net/niralimodha3/pharmaceutical-process-validationpptx

Types of Process Validation The guidelines on general principles of Process Validation mention
four types of validation. • Prospective Validation (Premarket validation) • Retrospective
Validation • Concurrent Validation • Revalidation
RequirementRequirement

Validation Terminology
Actual Result

Requirement

Qualification

Quality Assurance

Risk Assessments
Risk Assessments justify allocation of validation resources and can streamline the testing process.
They also serve as a forum for users, developers, system owners, and quality to discuss the system
which can have other intangible benefits
Deviation Tracking
FastVal records all deviations as they occur during electronic test protocol execution. If a test step
fails during testing, FastVal automatically generates a record of the issue.

Change Control for Validated Systems

Change Control is a general term describing the process of managing how changes are introduced
into a controlled System. Change control demonstrates to regulatory authorities that validated
systems remain under control during and after system changes.

*Prospective Validation

It is establishing documented evidence prior to process implementation that a system does what it
proposed to do based on pre-planned protocols

* Retrospective Validation

It is an establishing documented evidence that a process does what it is supposed to do based on

review and analysis of historic data.

* Concurrent Validation

Concurrent Validation means establishing documented evidence a process does what it is supposed
to do based on data generated during actual implementation of the process

*Revalidation

Re-validation provides the evidence that changes in a process and/or the process environment,
introduced either intentionally or unintentionally, do not adversely affect process characteristics and
product quality.

Assalamualikum Maam, I hope you’re well in this pandemic situation. My name is MD Fahad
Miagi, ID: 211-007-062. My presentation topic is ‘’Documentation procedure for documentation
process’’