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New Software Module Allows Cost-Effective Integration of MasterControl Training with External Document Repositories

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Software to Integrate and Complement Documentum Software and Agile Software Electronic Systems


SALT LAKE CITY – Dec. 1, 2006 – MasterControl Inc. today unveiled a new module that allows easy integration of MasterControl Training with external document repositories, such as Documentum or Agile, without the need for expensive custom coding. MasterControl Training is a robust and easy-to-use software solution that automates, streamlines, and effectively manages employee training, a critical factor in the FDA and ISO environments.

Most FDA-regulated and ISO-certified companies rely heavily on electronic repositories to store, manage, and control SOPs, engineering drawings, forms, work instructions, and other documents necessary for compliance. They may have invested substantial amounts in document management technology before realizing their other needs, such as employee training, which cannot be met by their current solution. In FDA and ISO sectors, companies are required to implement and document employee training to ensure that their personnel know how to perform their duties within company and industry guidelines.

MasterControl Document Connections enables companies to complement their Documentum or Agile or other repositories with MasterControl Training to help ensure regulatory compliance, promote efficiency, and keep training documentation always ready for FDA inspections and ISO audits.

In addition, MasterControl offers FDA-regulated companies a continuum of validation products and services that address different levels of software validation needs based on individual risk assessment. This line of products and services make continuous validation possible by dramatically cutting the time, pain, and cost involved in validating a system, reducing the risks of project implementation, and making it easier to validate software upgrades.

MasterControl Document Connections: Summary of Features

  • Surrogate InfoCards: The InfoCard is the MasterControl tool that summarizes information about every document in the system and serves as a placeholder for the document in the database. Every item in a repository will have a corresponding Surrogate InfoCard in MasterControl Document Connections. Surrogate InfoCards allow communication between the repository and MasterControl Connections, which then leads to an appropriate action in MasterControl Training.
  • Document Change Triggers Action: When a revised document (e.g. SOP, work instructions, etc.) in a repository is approved, MasterControl will trigger related tasks in MasterControl Training. For example, training tasks can be automatically sent to affected trainees when a document is revised in Documentum, Agile, or some other connected repository.
  • Multiple Document Connections: Multiple connections can be made to multiple repositories. This is beneficial for companies that store documents in multiple repositories (e.g., SOPs in one and engineering drawings in another), but would like to trigger training when changes occur in either.
  • External Links: MasterControl Document Connections will support external links and URLs from other repositories. This allows a user to view a file residing within an external repository directly from the MasterControl InfoCard. Users will be able to view any attached documents relevant to a training course directly from the MasterControl Training course.

MasterControl Training: Summary of Features

  • Automates Training Tasks: Automates assignment, monitoring, and verification of training tasks, including those triggered by changes to documents in Documentum, Agile, or another non-MasterControl electronic repository. A link in a notification e-mail points directly into the user's ?My Tasks? box. Trainees have access to their training records with a personalized folder that shows past training, course due dates, and future training.
  • Proof of Competency: Automates grading of online exams to ease training control burden
  • Random Exam Questions: Courses that require an exam can be configured so there will be a pool of questions prepared in advance from which the exam can pull questions randomly. This will ensure that a user who has failed the exam will not get the same questions in the same order during his/her second try.
  • Sequencing of Courses : Allows implementation of a progressive training program by sequencing training courses. Once a prerequisite is completed, the next course is automatically launched.
  • Optional Training Verification: For basic courses that don't require verification, training tasks can be configured to bypass it, greatly streamlining the process and reducing the burden on supervisors, who typically act as verifiers.
  • More Timely Verification: Assigning a ?course verifier? role allows sending the verification task to multiple users. When a certain supervisor is not available to verify a training task, another verifier can do it to ensure timely verification.
  • Analytics and Reporting: MasterControl's advanced analytics and reporting capability provides standard and customized reports to show the status of a training program. The system tracks and shows any training deficiencies that might jeopardize compliance. MasterControl Analytics includes dashboard, drill-down, and scheduling capabilities.

About MasterControl
MasterControl Inc. has been at the forefront of providing innovative electronic quality management systems since 1993. Hundreds of companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210-211, 820, 606; ISO 9000, ISO 13485, ISO 14000, and other ISO standards; and Sarbanes-Oxley Act requirements. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, implementation, and validation services. For more information, visit, or call 800-825-9117.

Documentum is a registered trademark of EMC Corporation. Agile is a registered trademark of Agile Software Corporation.