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Computer Systems Validation FAQs

The document discusses key concepts in pharmaceutical validation including: - Standard operating procedures (SOPs) which describe how to perform tasks consistently. - 21 CFR Part 11 which defines FDA guidelines for electronic records and signatures. - User requirements specifications which describe what users need from a system. - Validation plans which define the scope and goals of a validation project. - Installation, operational, and performance qualification documents which contain test cases to verify proper installation, functioning, and performance of a system. - Validation summary reports which provide an overview of a validation project. - Change requests which are used to manage changes made to a validated system.

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Futurethoughts
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5K views

Computer Systems Validation FAQs

The document discusses key concepts in pharmaceutical validation including: - Standard operating procedures (SOPs) which describe how to perform tasks consistently. - 21 CFR Part 11 which defines FDA guidelines for electronic records and signatures. - User requirements specifications which describe what users need from a system. - Validation plans which define the scope and goals of a validation project. - Installation, operational, and performance qualification documents which contain test cases to verify proper installation, functioning, and performance of a system. - Validation summary reports which provide an overview of a validation project. - Change requests which are used to manage changes made to a validated system.

Uploaded by

Futurethoughts
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Pharma Validation Interview Questions and Answers

Computer Systems Validation Interview Questions and Answers

What is an SOP

A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step
outline form how to perform a particular task or operation. Everyone in a company must follow the
same procedures to assure that tasks are performed consistently and correctly. Most companies have
a wide variety of SOPs that describe how to do different tasks. In many companies technicians and
operators are trained in how to follow individual SOPs and their training record specifies which SOPs
they are trained on and are authorized to use.

What is 21 CFR part 11

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration
(FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is
commonly called, defines the criteria under which electronic records and electronic signatures are
considered to be trustworthy, reliable and equivalent to paper records

What are user requirements

User Requirements Specification describes what users require from the System. User requirement
specifications are written early in the validation process, typically before the system is created. It is
written by the System Owner and End Users, with input from Quality Assurance. Requirements
outlined in the URS are usually tested in the Performance Qualification. User Requirements
Specifications are not intended to be a technical document; readers with only a general knowledge of
the system should be able to understand the requirements outlined in the URS.

What is a validation plan

Validation Plans define the scope and goals of a validation project. Validation plans are written before
a validation project and are specific to a single validation project. Validation Plans can include:

• Deliverables (Documents) to be generated during the validation process


• Resources/Departments/Personnel to participate in the validation project
• Time-Line for completing the validation project

What is an IQ document

Installation Qualifications are a collection of test cases used to verify the proper installation of a
System. The requirement to properly install the system was defined in the Design Specification.
Installation Qualifications must be performed before completing Operational Qualification or
Performance Qualification.

What is an OQ Document
Operational Qualifications are a collection of test cases used to verify the proper functioning of a
System. The operational qualification tests requirements defined in the Functional Requirements.
Operational Qualifications are usually performed before the system is released for use.

What is a PQ Document

Performance Qualifications are a collection of test cases used to verify that a System performs as
expected under simulated real-world conditions. The performance qualification tests requirements that
were defined in the User Requirement Specification (or possibly the Functional Requirements). Due to
the nature of performance qualifications, these tests are sometime conducted with power users as the
system is being released.

What is a Validation Summary Report

Validation Summary Reports provide an overview of the entire validation project. When regulatory
auditors review validation projects, they typically begin by reviewing the summary report. The
validation summary report should include:

A description of the validation project

All test cases performed, including if those test cases passed without issue

All deviations reported, including how those deviations were resolved

What is a Change Request

Change Control is a general term describing the process of managing how changes are introduced into
a controlled System. In validation, this means how changes are made to the validated system. Change
control is required to demonstrate to regulatory authorities that validated systems remain under
control after system changes. Change Control systems are a favorite target of regulatory auditors
because they vividly demonstrate an organization capacity to control its systems.

http://futurethoughtsllc.com/ValidationInterviewFAQ.aspx

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