MasterControl Business Process Library

When it comes to GxP process management solutions, one size does not fit all. Each life sciences company has unique processes, circumstances, and requirements that must be addressed by a variety of different solutions.

MasterControl offers Business Process Library subscriptions that allow companies to pick and choose suitable solutions according to their specific needs. Each subscription permits customers to access all MasterControl solutions for a 12-month period. The ever-expanding number of solutions available through the Business Process Library, in conjunction with implementation assistance and ongoing technical support, make it possible for MasterControl to offer customers those solutions most appropriate to their particular needs. Here are some examples of how MasterControl's versatile Business Process Library helps companies in regulated environments automate their GxP processes more rapidly.

How can MasterControl help you?

Challenges		MasterControl Solution

Limited Access: Most out-of-the-box GxP software solutions must be purchased either as an entire suite or a single system. ROI can be adversely affected when companies buy an entire suite and only use a portion of its capabilities. Purchasing software solutions system by system can be costly and stunt the growth and development of burgeoning companies.		Unlimited Acess: The Business Process Library provides companies access to any and all of the solutions that comprise MasterControl's integrated suite during the course of their 12-month subscription. Users have the flexibility to start with one solution and grow into others as requirements demand without spending additional funds on software.

Disconnected System: Using different software solutions for diverse GxP processes requires that manufacturers devote extra resources to manage separate systems.		Connected System: MasterControl BOM is traceable and secure and provides instantaneous electronic communication. Because the BOM is integrated with the document management system, in-process changes are readily viewed by buyers/planners and costly mistakes can be avoided. All parties involved in the supply chain are accountable for actions once changes are approved and communicated.

Slow Process: Installing, validating and deploying automated GxP process management systems can be a burdensome, time-consuming procedure.		Expedited Process: The Business Process Library facilitates automating more processes faster. The solution package relieves the pain of automating additional processes by offering instant access to a suite of best practice solutions. MasterControl's renowned implementation assistance and technical guidance helps customers roll out solutions more rapidly.

Mismatched System: Most companies offering document control and GxP process management solutions push software systems that customers may not want or need or that don't match the company's processes.		Customized System: The Business Process Library allows companies to utilize only those solutions that best fit their processes. As new needs arise or future MasterControl enhancements are made, companies can elect to add more solutions during the period of their subscription without extra cost.

Features and Benefits:

Business Process Library Subscription: Each subscription offers 12 months of access to the contents of the Business Process Library, which includes:

All current solution packages plus those that become available in the next 12 months
Coding samples, form samples, and form development utilities
Access to a Business Process Expert who will provide technical support on the solution packages
One day (eight hours) of remote Business Process implementation services
Notification of new solution packages as they become available

Business Process Library Subscription Renewal: Subscription renewal provides an additional 12 months of access to the Business Process Library, which will continue to expand based on MasterControl's ongoing product development. Renewal also provides continued access to Business Process Technical Support and one additional day of Business Process Implementation Services.

Solution Package PQ Library Subscription: PQ Library Subscriptions include 12 months of access to all Solution Package PQ templates available during that timeframe. Customers will be notified of new solution packages as they are developed. Subscription renewals provide an additional 12 months of access to the continually expanding Solution Package PQ Library.

Additional Available Services:

Implementation Services: Extra days of remote or onsite Business Process Implementation Services can be purchased by Business Process Library customers in addition to the one day provided with the subscription. Business process implementation services include:

Installing and configuring the Solution Package(s) according to specific installation checklists.
Customization of Solution Package (e.g., adding, removing, modifying fields or route steps during the installation).
Troubleshooting, changing, or updating an existing operational business process
Designing or implementing a new business process, including advanced forms creation and JavaScript coding

Business Process Consulting: MasterControl's Business Process Consulting service can provide a detailed design document that delineates clear specifications for forms implementation by either the user or MasterControl services. Once requirements are gathered onsite, a design is created incorporating the necessary form(s) to enable the defined process.

PQ Development and Execution Services: MasterControl Validation Services can assist customers with the complete development of customized Performance Qualification protocols for specific forms processes. MasterControl starts the development process by assessing usage procedures or work instructions for the forms process. A baseline protocol is then created that covers Data Integrity, Security Integrity and Electronic Approval Integrity testing for these processes.

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.