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.