Basics terminologies constantly used in computerized system validation . This is an initiative for all those IT, QA, facility managements

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Phone : +91 8000656594

2.  A computerized system is a function
integrated with a computer system .
 Generation, measurement, calculation,
assessment, transfer, processing, storage or
archiving of data
 Intended for regulatory submission or to
support regulatory decisions .

3.  ISO 13485 ; Clause 7.5.2.1 “validation of the
application of computer software for service
provision shall conform to specified
requirements”
 ISO 17025 ; Clause 7.11.2 “The laboratory
information management system(s)
………………shall be validated for functionality
……..by the laboratory before introduction

4.  OECD No.1 GLP : “ensure that computerized systems
used in the study have been validated”
 ICH E6(R2), GCP : “A process of establishing and
documenting that the specified requirements of a
computerized system ……… of the system or transition
to a new system.
 ICH Q7 (R2), GMP-related computerized systems
should be validated.
 A NEED FOR EVERY REGULATED SYSTEM …!!!

5. Lets understand the responsibilities
…!!!

6.  IT Personnel : purchase, installation and
maintenance of a computerized system.
 Supplier : Third parties, vendors, internal IT
departments, service providers including hosted
service providers .
 User : The personnel operating the
computerized system.
 System Owner / IT Owner :The individual who
is responsible for the availability, support and
maintenance of a system and for the security of
the data residing on that system. The System
Owner acts on behalf of the management.

7.  Validation Director: A delegated person responsible
for a validation project.
 Facility Management person(s) who has the authority
and formal responsibility for the organization and
functioning of the test facility according to these
Principles of Good Laboratory Practice.
 Quality Assurance (QA) has to review the validation
documentation and inspect the validation activities
for regulatory compliance.
 Personnel are responsible for performing activities
with computerized systems in accordance with the
GLP Principles and recognized technical standards

9.  Acceptance Criteria : The documented criteria
that should be met to successfully complete a
test phase or to meet delivery requirements.
 Acceptance testing Formal testing of a
computerized system in its anticipated
operating environment to determine whether all
acceptance criteria of the test facility have been
met .

10.  Authorization concept : A formal procedure to
define and control access rights to and privileges
in a computerized system.
 Back-up Provision made as a part of
contingency plan for the recovery of data files
or software or to restart processing, or for the
use of alternative computer equipment.

11.  Change Control: Evaluation and documentation
to determine whether a validation process is
necessary following any changes to the
computerized system.
 Change Management : Change management is
the process for the life cycle of changes.

12.  Configuration: A configuration is an
arrangement of functional units and pertains to
the choice of hardware, software and
documentation that affects function and
performance of the system.

13.  Corrective and Preventive Actions (CAPA)
The concept of corrective and preventive
actions focuses on the systematic
investigation of the root causes of identified
problems or risks in an attempt to prevent
their recurrence or to prevent occurrence.

14.  Data migration Data migration is the activity
of transporting electronic data from one
system (computer) to another, transferring
data between storage media or simply the
transition of data from one state to another

16.  Data approval Data approval means locking
data after collection and verification and e.g.
transformation to make data suitable for use
in records.
 Data capture Data capture are actions that
typically take place to plan, collect, and verify
data .

17.  Electronic record Any combination of text,
graphics, data, audio, pictorial, or other
information representation in digital form.
 Electronic Signature An electronic measure
that can be substituted for a handwritten
signature or initials for the purpose of signifying
approval, authorization or verification of specific
data entries.

18.  Hybrid system : Co-existence of paper and
electronic record and signature components.

19.  Life cycle : An approach to computerized
system development that begins with
identification of the user’s requirements,
continues through design, integration,
qualification, user validation, control and
maintenance, and ends when use of the
system is retired.
 Life cycle model : A life cycle model
describes the phases or activities of a project
from conception until the product is retired.

20.  Risk: Combination of the probability of
occurrence of harm and the severity of that
harm.
 Risk analysis: Estimation of the risk associated
with the identified hazards.
 Risk assessment : Risk assessment consists of
the identification of hazards and the analysis
and evaluation of risks associated with exposure
to those hazards .

22.  Security: The protection of computer
hardware and software from accidental or
malicious access, use, modification,
destruction or disclosure.
 Software A programme acquired for or
developed, adapted or tailored to the facility
requirements for the purpose of controlling
processes, data collection, data
manipulation, data reporting and/or
archiving.

24.  Views Expressed and errors , if any are attributable to
author. If you rely on the above views without a
personalize opinion or study and if you have benefits
you are free to keep it for yourself without any
ACKNOWLEDGEMENT !!!!
 It is a nutshell presentation for training and
understanding purpose only .
 For training session please mail at
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