Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (1st Books Library) - Softcover

Goldman, Stephen Robert

Softcover

ISBN 10: 1410737446 ISBN 13: 9781410737441

Publisher: 1st Book Library, 2003

Synopsis

This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib

About this title

About the 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.

Excerpt. © Reprinted by permission. All rights reserved.

Chapter 7 Project Plan

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 the outcomes of activities. The SOP on SOPs should govern the numbering methodology.

See Chapter 6 "The SOP on SOPs."

The Project Name and Number, if applicable, should be indicated on the cover or title page. This information identifies the overall project to which this document belongs.

The Site/Location/Department Identification should be indicated on the cover or title page. It identifies the Site/Location/Department that has responsibility for this document and its associated project.

The Date that the Document was issued, last revised or issued with draft status should be on each page of the document (e.g., 12-Dec-01). This will clearly identify the date on which the document was last modified.

The Effective Date of the Document should be on the title or cover page of the document (e.g., 12-Dec-01). This will clearly identify when to begin using the current version of the document.

Pagination, page of total pages (e.g., Page x of y), should be on each page of the document. This will help identify whether or not all of the pages of the document are present. Pages intentionally left blank should clearly be designated as such.

Approval Section (SOP)

The Approval Section should contain a table with the Author and Approvers printed names, titles and a place to sign and date the SOP. The SOP on SOPs should govern who the approvers of the document should be. The functional department (e.g., Production / Quality Assurance / Engineering) of the signatory should be placed below each printed name and title along with a statement associated with each approver indicating the person s role or qualification in the approval process. Indicate the significance of the associated signature (e.g. This document meets the requirements of Corporate Policy 9055, Electronic Records; Electronic Signatures, dated 22-Mar-2000).

The completion (signing) of this section indicates that the contents have been reviewed and approved by the listed individuals.

Table of Contents (SOP)

The SOP should contain a Table of Contents, which appears towards the beginning of the document. This Table of Contents provides a way to easily locate various topics contained in the document.

Purpose (SOP)

This introduction to the SOP concisely describes the document s purpose in sufficient detail so that a non-technical reader can understand it.

The Purpose section states the purpose of the SOP and an indication of the desired outcome, if appropriate. The areas, operations and procedures that are covered by the SOP are defined here.

The Purpose section should clearly state that the intention of the document is to provide a Standard Operating Procedure to be used to specify the requirements for the preparation of a Project Plan for a new or upgraded software application, computer or computerized system along with the required activities and deliverables.

Edition details

• Publisher: 1st Book Library
• Publication date: 2003
• Language: English
• ISBN 10: 1410737446
• ISBN 13: 9781410737441
• Binding: Paperback
• Number of pages: 472