ISO 9000 Certification
Highlights
For ISO 9000 certification, organizations must document the practices that impact the
quality of their products and services. Organizations are then expected to follow those
documented procedures in order to gain and maintain ISO 9000 certification. A
well-designed documentation system ensures that quality standards are met routinely,
provides immediate access to well-organized data, and tracks the approval process for ISO
9000 compliance. Cimage NovaSoft GMP from Cimage is an integrated document management
and workflow system that helps companies gain rapid document and information access, and
improve the quality and flow of information, with security, revision control and audit
trails assured every step of the way.
Document Access and Revision Control
Companies implementing ISO 9000 programs need to verify that employees have access to
only the latest, approved revision of a policy or procedure. Cimage NovaSoft GMP
documents are under
full distribution and revision control, allowing you to demonstrate that the correct
version of every document is available upon request. Its extensive search capabilities
provide rapid, consistent access to your most important documents. Relationships can be
established between documents so that when a change is made to one document, you are
automatically notified of affected documents. And, its logical document feature lets you
manage a group of files as a single document and still view, revise, and control each file
independently. Access privileges are controlled through a multi-level security schema that
extends to the document level.
Enterprise-Wide Coordination
The true benefits of ISO 9000 are realized when coordination extends beyond a single
department or site, to multiple sites or the entire enterprise. Cimage NovaSoft GMP
makes it easy to access, store, and track any type of
document, including business and technical documents, spreadsheets, CAD drawings,
electronic forms, raster images, audio, and video. Folders can be organized to match your
environment, whether within a single site or across multiple sites. And, its open
architecture and compliance to standards, as well ass its family of integration
tools, lets you integrate it with other applications in your business.
Workflow Management
Implementing procedures that ensure conformity with formal, consistent operating
practices, is key to ISO certification. With Cimage NovaSoft GMP, workflows can be easily created
using drag-and-drop icons. Cimage NovaSoft GMP notifies you via e-mail when a workflow task is in
your in-basket and launches the appropriate application, be it review, approve, edit, or
redline. With time-triggered notifications, bottlenecks in a process can be readily
identified. Response and approval threshold voting, sharable tasks, and serial and
parallel tasks, help shorten cycle times while maintaining full control of processes.
Audit History
A complete record of activities, procedures, and approval processes
must be documented , stored, and readily available to meet audits. Cimage NovaSoft GMP
workflows
include electronic signature components as well as a full audit trail capability that
tracks time and date stamps, action performed, work files, redlines, and other historical
data needed for ISO 9000 compliance.
Forms for Process Management
Consistent, complete information in forms – such as Corrective
Action Requests, Non-conforming material reports, training records, audit findings –
helps a company meet ISO 9000 standards. Cimage NovaSoft GMP's integrated electronic forms
capability lets you create forms, input data, and retrieve information by sorting on any
field in a form. Fields can be restricted to drop-down menu options, open to variable
input, etc. In this way, not only documents and drawings, but even data can be managed and
controlled by Cimage NovaSoft GMP and forms are under full revision control.
The Extended Enterprise
In today's competitive environment, many companies contract out
for component manufacture, packaging or even full product manufacture. These contractors
must adhere to the same regulations and ensure that the information is recorded, tracked
and passed to the company distributing the product. By allowing access to Cimage NovaSoft GMP
from
the multiple sites you can treat these contractors as extensions of your
company, with totally integrated document management.
Some of the documents that Cimage NovaSoft GMP manages:
- ISO 9000 regulatory documents and submissions
- Corporate policies and practices
- Engineering specifications and drawings
- Compliance audit records
- Corrective action requests
- Contractor records
- Test procedures and results
- Non-conforming material reports and waivers
- Product and process plans
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