Solution for Compliance in a Regulated Environment (SCORE)

• Provides full document life cycle and Electronic Common Technical Document life cycle management from creation through submission
• Delivers compound document assembly, Electronic Common Technical Document assembly, communications and correspondence management and registration status tracking
• Includes enhanced support to run in a service-oriented architecture (SOA) environment, including Web services interfaces to ease integration with other applications
• Applies to regulated business processes, including R&D, clinical trials, regulatory affairs/submissions, packaging and labeling, marketing materials and advertising
• Helps you manage the impact on your regulated document value chain by managing standard operating procedures (SOPs), material safety datasheets and more
• Addresses compliance and regulated document management requirements across multiple industries and applications
• For more information on SCORE, please see the LifeSciences solutions.

Change metrics definitions

Authorized User: An Authorized User authorization must be obtained for each individual user accessing the program in any manner. Each Authorized User authorization is attributable to one and only one individual user, either within or outside your enterprise. An Authorized User authorization is required for each individual user who accesses the program or any component, application, feature, function and/or capability thereof, either directly or indirectly, through any means on behalf of the user.

Users require authorization for accessing content managed within, and/or distributed from the program server. Each Authorized User authorization entitles one individual user to establish one or more connections to any number of program servers across any of the supported platforms. An Authorized User authorization may only be reassigned for the long-term replacement of personnel. The programs may be installed on one or more computers, and accessed by multiple users, provided that an Authorized User authorization has been obtained for each individual user.