CSV Good Documentation and Test Practices For GXP

Computer System Validation
and,
Good Documentation
Practices for GxP Systems
Agenda
What is CFR Part 11

What is Computer Systems Validation
What is good documentation
Background and purpose
Authoring of documents
Changes and Modifications
Objective Evidence
Deficiencies Documentation
GxP Documentation
What is CFR Part 11

Its the FDAs final rule on Electronic Records
and Electronic Signatures
Defines requirement underwhich electronic
records and signatures are equal to paper
Requires regulated industries to implement
controls including audits, system validation,
electronic signatures and documentation of
software and systems involved in the
processing of data
What is Computer System

Validation (CSV)
Computerized System Validation is an ongoing process which

involves the evaluation and documentation of all components of a
system during its lifecycle phases to ensure compliance with the
authorized user requirements.
Computerized System Validation requires establishing documented
evidence which provides a high degree of assurance that a system
meets its predefined specifications, performs and will continue to
perform accurately and reliably, and is secure from unauthorized
or accidental change.
The major reasons for validating computerized systems are:
Ethics: CSV helps by ensuring that systems function as intended
thereby minimizing risk to patients and their families.
Control: CSV provides a framework for management control of
complex computerized systems.
Compliance: CSV is a regulatory requirement.
More About CSV
Responsibilities: The ultimate responsibility for validating a

computerized system rests with the identified Business
Owner. The Quality Assurance (QA) group must monitor,
audit and authorize the validation.
Policy Statement : All organizations will have a CSV Policy.
All new systems within the scope of the CSV policy must be in a
validated state prior to their operational use. Existing systems within the
scope of this policy, if not yet validated, must be retrospectively
validated.
All systems within the scope of this policy must be maintained in a
validated state.
CSV Requirements: All CSV activities must fully comply with this Policy
and it is strongly recommended that such activities should follow the
concepts in the Corporate CSV Guidelines.
Corporate CSV guideline will provide the principles for performing system
validations
GxP Systems Documentation

Deliverables
Vendor Audits
GxP Assessments
Part 11 Assessments
Master Validation Plan
User and Functional requirements
Risk Assessments
Technical Architecture documents
Installation Qualifications
Operational Qualifications
Performance Qualifications
UAT
Qualification reports
User Operating Procedures (SOPs)
System Administration Procedures
End User Training
Traceability Matrix
Validation Summary Report
System Release Memo
WBS For a Validated System
Documentation Descriptions
The Project Charter: This describes the reason for the project and defines the scope of the
project. This deliverable provides the framework for the validation project and justifies its
business need.
Validation Plan: This document represents one of the key deliverables and is one of the
most important documents in a CSV project. It outlines the strategy and remediation strategy
for new and legacy systems. The main objective of this document is to achieve full
compliance with corporate computer system validation strategy. It is this document that
provides the details regarding the subsequent documentation that will be required for
validating the computer system. This plan also describes the methodology to be used for
obtaining compliance for the system at hand, providing guidance to the validation team in
terms of understanding and executing validation activities.
Functional Specification, Design Specification and User Requirements: These documents

specify requirements needed for a system, from both a user and hardware perspective .The
most important of these is the Functional Specification document which details all the
functional needs required for an application. This document is where the specifics of the
computer application are documented and acts as a living document which is updated if any
further changes are made to the application. This document defines what the expected predetermined specifications of the computer application should be.
Test Plan: The test plan defines in detail the effort that will be put into the testing of the
application. It clearly specifies all the stages of testing that a computer system will go
through and provides a scope of the amount of testing which will be conducted for a system.
Documentation Descriptions
Installation Qualifications: Defines the qualifications for the installation procedures which will
be required for the implementation of the software. Here all the required installations are
qualified, which means that the installation will follow a defined process and will meet the
requirements of the organization and more specifically the defined project needs. Installation
qualification will test the Design Specifications.
Operational Qualifications: Describes how the application will function and whether it will
meet its described functions. Operational Qualification tests all the features described in the
Functional Specification. Specific test scripts are written for each of the features in the FRS and
the applications capability is verified. This verification is to ensure that the application will meet
the needs of the organization.
Performance Qualification: Represents a series of documents which ensure that the

application will meet the production standards defined by the organization and detailed in the
user requirements. Here again a series of production scripts are written and the application is
tested to ensure that it is capable of meeting the desired results. It is only after the formal
execution of the production scripts and the formal signing of the Performance Qualifications that
a computer application can be moved into production..
Summary Reports: These reports summarize the results of the executed qualification
documents. Here the summarized information recaps all the qualification standards used and
what the results and deviations for IQ, OQ and PQ qualifications are.
Deviations Reports: This is a set of documents that formally logs any deviations from the
expected results during the formal Operational and Performance qualifications.To
Introduction of GDP
Good documentation practices must
adhere to the following GxP (x=
Manufacturing, Laboratory and Clinical):
Authoring
Changing
Maintaining
Distributing
Of documents related to Validation and

Qualification documents
Background and Purpose

Must ensure that documents can reliably serve as
proof of actions and results
Must clearly define the documentation of the practices
Must provide clear instructions on how to create,
approve, scan and store documents
All employees have to be trained in the practices
Applies to all validated environments
Must be unambiguous in the content,
Must state the scope clearly of each document defined
Each document must have a unique identifier
Authoring of Documents
Author needs to assign a unique identifier for the document
Author is responsible for tracking the document throughout
its development and approval life cycle
Author will distribute the document to appropriate reviewers
Author will address all the questions and comments
addressed by the reviewers
Author will ensure all approvers have signed the document
Author will be responsible for the version control of the
document
Author will ensure the document is properly filed
Author will be responsible for any changes made to a final
approved document and reversion the document
Author will be responsible for capturing all the edit history
of the document
Document Changes and Modifications

to Final versions
Good documentation practices must follow the following for document

changes and modifications. These are:
Must maintain revision history section showing full name of person
who made changes
Specific description of the changes must be written clearly
Date of when changes were made must be indicated
Version number of the document to which changes were made
must be documented
All comments and suggestion cannot be addressed in the final
version, are allowed only in draft versions of the document
Final version changes must be done within the change control
standards of the organization
Each document must contain a official signature log containing the
printed name, signature and initials of each person modifying the
document
Initialing of the document must be kept consistent
Predating and posting changes is not allowed
Handwritten modifications to
documents
Handwritten entries to GxP related documents are acceptable but

can only be done in the following manner
Must use permanent blue or black ink

Use of correction fluid and correction tape is not permitted
Must record the date and must be consistent to the with the international
format ddMMyyyy
Must clearly indicate the change made
Must include the signature and name of the person making the modification
Must update the official signature log of the document
A fax or printed PDF of the official signature must be attached to the original
record
Must inform the author of the changes
Following steps must be adhered to when a hand correction is

made
Draw a single line through the area of correction

Enter the corrections
Include an explanation for the change
Initial and date the change
Objective Evidence
Where Objective Evidence is needed the following
are the practices necessary
Must be collected, paginated and dated by the tester
Predating and post dating are not permitted
Evidence must contain page number, total number of
pages and testing steps
For systems must produce screen shots of the
evidence
Must show completion of the test
Must mark any deviation from expected results clearly
Must mark successful test steps clearly
Must be able to repeat the steps tests are successful
Deficiencies
documentation
All deficiencies of in testing must be

accompanied by a Deficiency Report.
(DRF)
Must be filled for each deficiency encountered
Deficiencies occur when expected result does
not match the actual results
DRF should also be created when there are
missing approval on testing procedures
A log of all deficiency reports need to be
maintained

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What is CFR Part 11 and what are its requirements?

What is CFR Part 11 and what are its requirements?

What is Computer System Validation and what are its major purposes?

What is Computer System Validation and what are its major purposes?

Computer System Validation

What is CFR Part 11

What is CFR Part 11

What is Computer System

Computerized System Validation is an ongoing process which

More About CSV

Responsibilities: The ultimate responsibility for validating a

GxP Systems Documentation

WBS For a Validated System

Functional Specification, Design Specification and User Requirements: These documents

Performance Qualification: Represents a series of documents which ensure that the

Of documents related to Validation and

Background and Purpose

Document Changes and Modifications

Good documentation practices must follow the following for document

Handwritten entries to GxP related documents are acceptable but

Must use permanent blue or black ink

Following steps must be adhered to when a hand correction is

Draw a single line through the area of correction

All deficiencies of in testing must be

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