News

MasterControl Announces Electronic Batch Record Solution

SALT LAKE CITY – August 16, 2007 – MasterControl Inc., the leading provider of compliance management software solutions for the life science industry, today announced the availability of MasterControl Electronic Batch Records™, a powerful solution for automating and controlling batch record processes.

MasterControl Electronic Batch Records is based on the Instrumentation, Systems and Automation Society’s S88 model (ISA-S88 or S88).  This automated batch record system helps ensure GMP compliance and increase efficiency in creating and managing master recipes and control recipes. 

The batch record solution creates a flexible framework to model a wide range of manufacturing processes in accordance with the S88 model for electronic batch records.  It can handle a mix of parallel and sequential processing steps or unit procedures under the same recipe.  The system helps ensure the capture of all data critical to GMP compliance in master and control recipes.

MasterControl Deviations™ can be seamlessly integrated into MasterControl Electronic Batch Records to record, assess, and approve a planned or unplanned deviation into an overall manufacturing process.  Deviations also serve as the link to other MasterControl modules such as MasterControl Nonconformance™ and MasterControl CAPA™.

MasterControl Electronic Batch Records users benefit from form-to-form launching, a feature allowing relevant data to be transferred automatically from one form to another, linking the forms and reducing manual data entry.  Through the same mechanism, a Deviation form can be launched from a Control Recipe form, triggering a separate quality review process.

“Regulated environments create unique demands on manufacturing departments which struggle to meet efficiency goals as well as quality demands,” says MasterControl Project Manager Oliver Wolf. “Batch records define a manufacturing process, enforce quality constraints and provide a crucial auditable record for every manufactured batch. We are very excited to extend MasterControl's offerings for the manufacturing floor to streamline these important functions. MasterControl Electronic Batch Records is a complete solution for the management of master recipes, production control and storage of manufacturing records that seamlessly integrates with the core suite familiar to our customers."

Web-Based Portal Functionality – Batch Record
As with all MasterControl applications, MasterControl Electronic Batch Records utilizes the MasterControl web-based portal which provides the following benefits:

• Analytics and Reporting Tool:  The MasterControl batch record system has a built-in analytics tool that comes with a standard set of pre-configured reports that can be adjusted and customized by the end user.  Production records can be trended and analyzed.  These “data-mining” capabilities can give important insights into overall production activities such as turnaround, quality issue rates, etc.
• Validation Offerings: For FDA-regulated companies, MasterControl provides a full product line of validation offerings that are designed to dramatically cut the time, pain, and cost involved in computer software validation.
• Compliant System:  21 CFR Part 11 requires an audit trail as a key control in making electronic records reliable. MasterControl products maintain a secure, time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record.  The software records when the action occurred and the reason changes were made. MasterControl meets FDA requirements for electronic signature and software validation. It facilitates compliance with regulatory standards such as ISO 9000 and ISO 13485.

About MasterControl
MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise.  Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management. For more information, visit www.mastercontrol.com, or call 800-825-9117.