Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
by
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NIST defines a project plan as “A management
document describing the approach taken for a project. The plan typically
describes work to be done, resources required, methods to be used, the configuration
management and quality assurance procedures to be followed, the schedules to be
met, the project organization Project in this context is a generic term. Some
projects may also need integration plans, security plans, test plans, quality
assurance plans” This chapter will provide procedures to be followed for
creating project plans specific for validation work. It specifies the requirements for a plan that will determine how
the project is rolled out and managed.
Best industry practices and FDA Guidance documents
indicate that in order to demonstrate that a computer or computerized system
performs as it purports and is intended to perform, a methodical plan is needed
that details how this may be proven. It
lays out what is to be done, how it is to be accomplished and the resources
required for completion of each activity.
This SOP is used for all systems that
create, modify, maintain, retrieve, transmit or archive records in electronic
format. It is used in conjunction with
an overlying corporate policy to provide sustainable compliance with the
regulation.
Everyone involved in projects for a software
application, computer or computerized system that controls equipment and/or
produces electronic data or records in support of all regulated laboratory,
manufacturing, clinical or distribution activities uses this SOP.
Title Block, Headers and
Footers (SOP)
The Project Plan SOP should have a title block,
title or cover page along with a header and/or footer on each page of the
document that clearly identifies the document.
The minimum information that should be displayed for the Project Plan
SOP is as follows:
Document Title
Document Number
Document Revision Number
Project Name and Number
Site/Location/Department Identification
Date Document was issued, last revised or draft
status
Effective Date
Pagination: page of total pages (e.g., Page x of y)
The Document Title should be in large type font that
enables clear identification. It should
clearly and concisely describe the contents and intent of the document. Since this document will be part of a set or
package of documents within a project, it should be consistent with other
documents used for the project. This
information should be on every page of the document.
The Document Number should be in large type font
that enables clear identification.
Since the Project Plan SOP will be part of a set or package of documents
within a project, it should be consistent with other documents used for the
project. This information should appear
on every page of the document.
The Document Revision Number, which identifies the revision of the document, should appear on each page of the document. Many documents will go through one or more changes over time, particularly during the draft stage and the review and approval cycle. It is important to maintain accurate revision control because even a subtle change in a document can have an immense impact on t
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About the Book
Much has been written about “why” to validate. The Handbook of Computer and Computerized
System Validation for the Pharmaceutical Industry is an SOP-centric explanation
of “how” to validate. Creating a state
of sustainable compliance with FDA regulations including 21 CFR Part 11,
Electronic Records; Electronic Signatures is daunting task. This handbook follows FDA guidelines and
“Best Industry Practices” in defining the roles, responsibilities, and
requirements of computer and computerized system validation for the
pharmaceutical, biotechnology, and medical device industries. It details the requirements for Standard
Operating Procedures and Protocols for User Requirements, Functional
Requirements, Design Specifications, Installation Qualification, Operational
Qualification, and Performance Qualification.
21 CFR Part 11 Assessment and validation gap analysis methods are
prescribed to determine the state of compliance of systems with current
regulation. The first requirement of 21
CFR Part 11 is “Validation of systems to ensure accuracy, reliability,
consistent intended performance, and the ability to discern invalid or altered
records.” This book explains how to
comply with this and other requirements of 21 CFR Part 11.
About the Author
Stephen Goldman
Senior Compliance Director, Subject Matter Expert,
Author
Stephen Goldman is a Senior Compliance Director and
Consultant specializing in 21 CFR Part 11 training, assessment, remediation,
validation and project management to provide sustainable compliance in the
regulated pharmaceutical environment.
He has provided Subject Matter Expert guidance and training for gap
analysis and remediation of computer systems validation for a major
pharmaceutical company under an FDA Consent Decree. He has performed engineering and validation services for two
remote data entry systems for use in clinical trials.
He has managed and conducted numerous training
programs for end-user training in basic computer operation and use, network
environments, custom Lotus Notes applications, and other specialized
programs. He has prepared course
material and provides training for an ACPE accredited conference on Planning
and Remediation of Systems for Part 11 Compliance and Planning and Checking,
Part 11 Assessment and Remediation
of Systems for Part 11 Compliance.
Mr. Goldman’s background in electrical engineering,
manufacturing, defense, pharmaceutical, and biotechnology enables him to relate
to most types of business operations.
He designs and implements IT solutions to streamline workflows within
organizations.