 |
|
Document Control
& Management System (DocMan) Architecture
QA (quality assurance)
and RCV (regulatory compliance and validation)
managers
have long recognized that with increasing
workloads, rapidly changing regulatory
requirements, tighter timelines and fewer
resources require an efficient document
creation, distribution and control system.
While it has never been easier to
create, duplicate and post documents, it has
also never been more difficult to control
them. There
is a significant difference between the terms
“Document Management” and “Document
Control” and understanding the clear
distinction is critical when implementing a
system to meet ISO 9000 and 21 CFR Part 11
requirements.
Document
Management: In general, the steps of creating, editing, viewing, storing,
distributing and archiving constitutes the
process of document management. Recently, it
has become a generic term to describe the
process of converting a paper-based document
by scanning to electronic formats.
Document
Control:
The term specifically refers to a set
of guidelines required based on company and
regulatory requirements that control the
creation, modification and access of
electronic documents, including maintaining
the document’s creation history, its
distribution list and usage.
Document
Publishing: The process of document posting and distribution to a
controlled work group in a secure and an
auditable environment is the key to
accomplishing a successful deployment of a
document management and control system.
DocMan™
Portal Server offers a number of features to
help streamline your document management,
control and publishing needs such as:
-
Version
tracking to record the history of
documents.
-
Application
of descriptive, searchable information
(metadata) to identify a document.
-
Document
publishing control.
-
Automated
approval routes for documents to be sent
to reviewers.
-
Web
discussions for online comments by
multiple document reviewers.
-
Control
of document access based on roles.
|
|
|
