Software speeds approvals in regulated environments.

Press Release Summary:



MASTERControl v7.0 FDA Edition provides side-by-side document comparison capabilities to enhance user's ability to comply with 21 CFR Part 11. This feature enables users to make educated decisions regarding acceptance or rejection of changes during approval of final documents. Packet approval tab displays identity of user who launched packet, along with launch date and time. Packet History Report tracks average time it takes to complete packet.



Original Press Release:


Document Control Systems Introduces MASTERControl 7.0 FDA Edition


Side by Side Document Comparison Capabilities Enhance User's Ability to Comply with 21 CFR Part 11

SALT LAKE CITY - April 15, 2002 - Document Control Systems, Inc.,
developer of the leading document control software, announced today the release of MASTERControl 7.0 FDA Edition. This latest upgrade to Document Control Systems' powerful change management software features enhancements that will speed document creation and approvals in regulated manufacturing environments.

MASTERControl's FDA Edition was initially introduced in 1998 and has since successfully enabled hundreds of companies to comply with FDA requirements, including 21 CFR Part 11. The technology's secure electronic environment provides enterprise-wide change management including revision control with full audit trail trace-ability and customizable, time-based routing and approval capabilities. This off-the-shelf configurable product is designed for ease-of-implementation and can be installed, configured and validated rapidly through its complete set of pre-written validation tools and test plans.

Now, MASTERControl 7.0 FDA Edition provides an even more streamlined, user-friendly change management capability. One of the most significant enhancements is side-by-side document comparison functionality that allows users to compare the original document and a modified document and see the differences between them - all within the MASTERControl
interface, including collaboration and electronic approval. Individual users can customize the manner in which modifications are displayed with a variety of colors and characters and an embedded, hyperlinked summary provides access to the justification for each change.

The integration of document comparison functionality with MASTERControl facilitates the collaborative effort to create accurate, well-planned documents or packets of documents. Additionally, the ability to compare documents and supporting audit trails enables users to make educated decisions regarding the acceptance or rejection of changes during the approval of final documents, increasing efficiency and reducing cycle
time.

Other 7.0 Enhancements Highlighted

Other additions that will result in time and costs savings include:

- Packet approval tab: Now, tracking is easier with a packet approval tab that will display the identity of the user who launched the packet, along with the launch date and time.

- Requirement of users to add comments when rejecting a packet: This feature will reduce the time needed to research the reasons a packet was rejected, boosting information quality and clarity

- Capability to copy workgroups: Users can now copy existing workgroups rather than having to recreate them from scratch.

- Packet History Report: This report tracks the average time it takes to complete a packet, making it easier for company management to calculate a ROI.

- Packet Approval/Abort History: Now packets that have been rejected are highlighted in red, while accepted packets are highlighted in black.

Additionally, the user that aborted a packet is identified. Both
enhancements facilitate system administration.

- Route Filtering: Existing route histories can now be filtered, making it easier for companies to identify the most effective route from among hundreds of potential routes.

Brad Wright, president of Document Control Systems, said the latest enhancements to MASTERControl's FDA Edition are the result of feedback received from the hundreds of users of previous versions of the software. "We are constantly eliciting feedback from our customers and evaluating our products to ensure maximum ease-of-use," he said. "We believe our attention to customer comments, along with our own continuous internal evaluation process, are the reasons that MASTERControl 7.0 FDA Edition is the best document control application available in the market today."

About Document Control Systems
Document Control Systems develops and manufactures software designed to address concerns associated with FDA, manufacturing and engineering document collaboration, control and approval processes, including validation and 21 CFR Part 11 compliance. The company's software products have been designed for strict FDA GxP, ISO 9000, ISO 14000 and QS-9000 document control and quality management requirements. Unique in its approach to document control and change management, MASTERControl is the only software that combines powerful time-based routing capabilities with a completely secure document vault system that
protects the integrity of documents by embedding them within the
software's database.

MASTERControl's FDA Edition was the first change management software to enable pharmaceutical, biotechnology, medical device and other FDA-regulated industries to meet FDA GxP requirements and to comply with 21 CFR Part 11. For more information, visit www.mastercontrol.com or call 800-825-9117 for pricing.

MASTERControl(tm) 7.0 FDA Edition

Fact Sheet

MASTERControl 7.0 FDA Edition provides change management and document control software that enables pharmaceutical, biotechnology, medical device and other FDA regulated industries to meet FDA GxP requirements and to comply with 21 CFR Part 11.
MASTERControl 7.0 FDA Edition:

- Has been successfully implemented, validated and inspected in FDA environments without any instances of non-compliance since 1999.

- Is the only software that combines powerful time-based routing
capabilities with a completely secure document vault system, which protects the integrity of documents by embedding them
within the software's database.

- Dramatically reduces the time it takes to bring a new product to market by speeding up the process for document change, approval, notification and distribution.

- Is an off-the-shelf configurable product designed for rapid
installation, implementation and validation.

Features/Capabilities:

- Side-by-Side Document Comparison

Displays an original document, a modified document and a comparison document and the differences between them - all within a single interface.

- Packet approval tab

Tracking is easier with a packet approval tab that will display
the ID of the user who launched the packet, along with the launch
date and time.

- Requirement of users to add comments when rejecting a packet
Reduces the time needed to research the reasons a packet was
rejected, boosting information quality and clarity

- Capability to copy workgroups

System administrators can now copy existing workgroups rather
than having to recreate them from scratch.

- Packet History Report

This report will track the average time it takes to complete a
packet, making it easier for company management to calculate a
ROI.

- Packet Approval/Abort History

Packets that have been rejected are highlighted in red, while
accepted packets are highlighted in black. Additionally, the user that aborted a packet is identified. Both enhancements facilitate system administration.

- Route Filtering

Existing route histories can now be filtered, making it easier
for companies to identify the most effective route from among
hundreds of potential routes.

- Change tracking and change rationale

Records the date, time, changes and rationale for changes made to
documents.

- Audit trail and reporting functionality

Facilitates complete compliance with FDA reporting, auditing and
tracking requirements for FDA GxP and 21 CFR Part 11 regulations.
- Electronic signature management and control

Ensures the security and integrity of documents with the following:

Dual signature path

32-bit password encryption

Password expiration

Intruder lock-out

Account lock-out

- Scalable, open systems architecture

- Windows 95/98/NT/2000 based

Requires an Intel Pentium Processor with a minimum 32 MB RAM

- Supports major client/server databases such as:

Oracle® 7.x, 8x, Windows NT 4.0, 2000, Microsoft® SQL Server 7.0, 2000

- Document Types

Side-by-side comparison tool supports Microsoft Word documents
only.

- Computer systems validation plan and implementation

Professional services and a complete set of pre-written
validation plans for IQ (Installation Qualification), OQ
(Operational Qualification) and PQ (Process Qualification) are
available for MASTERControl FDA Edition and other Document Control Systems' products.

All Topics