The document outlines a structured validation plan that defines critical components such as user requirements, design specifications, and testing qualifications. It includes the roles, responsibilities, and acceptance criteria for validating software and ensuring it meets specified requirements. Various phases of validation, including installation, operational, functional, and performance qualifications, are emphasized to ensure comprehensive evaluation and verification of the software.

1. 01
PLAN
VALIDATION PLAN
Clearly define what need to be validated,
the approach, roles & responsibilities and
acceptance criteria.
08
REPOR
T
VALIDATION REPORT
Write a report summarizing all the activities
performed as planned & test results against
acceptance criteria.
02
URS
USER REQUIREMENT SPECIFICATIONS
Define user’s need from the software.
Describe how regulatory, safety and
operational requirements will satisfy.
07
PQ
PERFORMANCE QUALIFICATION TESTS
PQ or User Acceptance Tests confirm if
the build software meets all user needs as
detailed in the URS.
03
FS
FUNCTIONAL SPECIFICATIONS
Detail how the software will meet user needs.
Include methods to capture data, logics and
calculations. Look of report.
06
OQ
OPERATIONAL QUALIFICATION TESTS
OQ or Functional testing confirms the
build functions are working correctly as
per the Functional Specifications.
04
DS
DESIGN SPECIFICATIONS
Detail design of database, user interface,
security, architectures, logics, processing
steps, networks etc.
05
IQ
INSTALLATION QUALIFICATION TESTS
IQ tests conforms if the developed software
meets all design specifications.
Verify
Verify
Verify
Verify
COMPUTER SYSTEMS VALIDATION STEPS
CONFIGURATION
INSTALLATION