A computerized System validation plan is produced for each GXP regulated computerized
system.
The plan should define.
What activities are required
How they will be performed
Who is responsible
What the output will be
What are the requirements for acceptance
How compliance will be maintained for the lifetime of the system
The level of detailing in the plant depends on the complexity, novelty and risk associated
with the system.
A generic or common plan may be used for similar systems, but. Characteristics of specific
systems should be adequately reflected.
If there are any changes to the plan, it must be dealt according to the specific change control
procedures.
This plan may be the first. Document offered during an inspection or audit to demonstrate
regulatory compliance. Hence it should be written at a level suitable to be understood by a
wider readership jargon and technical details should be avoided.
Contents of the Validation Plan includes:
Introduction and scope.
System overview.
Organizational structures.
QRM
Validation strategy.
Deliverables.
Acceptance criteria.
Change control.
SOPs
Supporting Process
Glossary
1. Introduction and Scope
This includes:
Objective: The objective of the validation process is to confirm—with objective,
documented evidence—that a product, system, or process meets its intended use and real
user needs, operates correctly in its target environment, and complies with applicable
requirements and regulations.
In practical terms, good validation aims to:
Ensure fitness for purpose: the solution solves the right problem for the intended
users under real or simulated operating conditions.
Protect safety and quality: identify and mitigate risks before release to reduce
defects, failures, and harm.
Demonstrate compliance: provide traceable evidence that regulatory, standards, and
contract requirements are met.
Build confidence and reduce liability: show stakeholders that outcomes are reliable
and repeatable, not accidental.
Scope: The scope of a system is the clear boundary of what the system will do, what it will
not do, and how it interacts with external users and neighboring systems. It defines included
functions, interfaces, constraints, and exclusions so stakeholders share a common
understanding of the system’s responsibilities and limits. Examples of scope of a Hospital
Patient Management System are:
Patient registration and demographics: create/update patient records,
identifiers/MRN, insurance details, emergency contacts, consent.
Appointments and scheduling: outpatient booking, provider/room calendars,
reminders, no-show handling, triage prioritization.
Admission, discharge, transfer (ADT): bed management, ward/room assignments,
waitlists, transfers between units, discharge workflows.
Applicable main regulations
Review, maintaince and update process for the plan itself.
2. System overview- It should include the business purpose and the intended use of the
system, The description of the system. And the description of the data generated by
the system.
3. Organizational Structures:
4. QRM: Any specific QRM procedures or standard followed should be defined. .
5. Validation Strategy:
6. Validation Deliverable: Validation deliverables refer to the documents or artifacts
produced during a validation process, often in industries like pharmaceuticals or
manufacturing. These documents ensure systems, processes, or products meet
predefined standards and requirements. Examples include a validation plan,
protocols, test scripts, reports, and traceability matrices. They help confirm the
system or process works as intended.
7. Acceptance Criteria:
For the development using incremental and iterative approaches, they acceptance criteria
will typically be defined in the Minimum Viable Product and Definition of Done.
An MVP is the smallest, simplest version of your product that still solves the main
problem for early users.
You build just the must-have features, launch quickly, and see how real people use it.
The goal is to learn what works (and what doesn’t) before spending lots of time and
money.
A “Definition of Done” (DoD) is a clear, agreed checklist of criteria that work must meet
to be considered truly complete and releasable
When applying incremental or iterative models and methods, the approach to reporting and
acceptance for each release should be considered and defined. Whether an updated
validation report or equivalent is required, or whether this may be controlled through
another mechanism.
8. Change control.
9. SOPs: There’s office to be created, updated and released as a result of the
implementation of the system should be defined. And the plan should identify the
responsibility for their production review and approval..
10. Supporting processes. Details of relevant supporting processes like training,
documentation, management, maintenance, operational process should be
described.
11. Glossary: A glossary is a list of important terms and their definitions, usually found at
the end of a document or as a separate section. It helps readers quickly understand
key words, acronyms, and jargon used in the text.
VALIDATION POLICY
Regulated companies should have a corporate level policy documents that defines the
overall approach.
A valuation policy should define the standards, templates, and procedures that are expected
to be followed throughout the organization.
It should define the requirement of the records and knowledge management as well as
expectation of the deliverables.
VALIDATION MASTER PLAN
The VMP should be a clear and concise summary document, typically covering:
• Summary of facilities, systems, equipment, or processes in scope, and the respective
validation status
• Current status of these facilities, systems, equipment, or processes
• Change-control process to be followed
• Planning and scheduling (including activities for new systems, activities driven by change,
and periodic review)
The responsibility for creating the validation master plan rests with the senior management.
The quality unit should approve the policy and procedures.
The VMP should be a summary document that is brief, concise, and clear. It should cover:
• Scope
• Reference to relevant policies
• Organizational structure
• Summary of facilities, systems, equipment, and processes
• Record types, content, availability, and retention
• Planning and scheduling
• Change control
• Reference to existing documents
