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OmniGuide, Pioneer in Fiber Technology for Minimally Invasive Laser Surgery, Selects MasterControl

SALT LAKE CITY – Mar. 5, 2007 – MasterControl Inc. today announced that OmniGuide Inc., a pioneer in the fiber technology for minimally invasive laser surgical therapies, has chosen the MasterControl suite to help increase overall efficiency and simplify FDA compliance.

OmniGuide, based in Cambridge, Mass., pioneered the revolutionary hollow-core photonic bandgap fiber used for minimally invasive CO2 laser surgery. This type of laser surgery offers precision and control over tissue, and essentially extends a doctor's physical reach within the body to treat complex lesions, and can transfer surgical procedures from the Operation Room into the office. The OmniGuide technology is used for operations in and around delicate tissue structures, particularly endoscopic pituitary procedures, head and neck cancers, laryngeal lesions, airway obstructions, and respiratory papillomas.

"With MasterControl, we can fully automate our processes, and speed up the document approval life cycle. We expect to greatly reduce our reliance on paper," said Michael Wilkins, documentation control coordinator at OmniGuide.

The company wanted to optimize its document management and training control processes, and incorporate the use of electronic signatures. "We handle up to 40 DCOs [document change orders] every week, and each packet contains multiple documents. We're talking about a lot of documents that need to be managed," added Wilkins.

OmniGuide chose MasterControl over five other software solutions. "What I really like about MasterControl is its modular approach. We can concentrate on one process and one module at a time, making it very convenient," said Wilkins. OmniGuide will be implementing the MasterControl™ suite, consisting of:

• MasterControl Documents This core application manages documents in a secure environment. It automates task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval for all documents-based processes. It provides a single Web-based repository for all documentation, making search and retrieval easy. Document types, vaults, lifecycles, routes, and users' roles are all configurable.
• MasterControl Forms Automates forms-based processes, such as change control, audit, nonconformances, deviations, and customer complaints. It makes the transition from a paper-based system to an automated solution easy because it allows users to create electronic forms identical to their existing hard-copy forms. Companies can also design new forms to suit their needs.
• MasterControl Training Automates assignment, monitoring, and verification of training tasks, and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed; the next one is automatically launched. Training control can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
• MasterControl CAPA Provides best-practice electronic forms and workflow routes that can be used as is, or customized based on a company's needs, including the "8D" process to guide a team throughout CAPA implementation. It provides the capability to launch a CAPA form directly from another form (e.g., audit finding, customer complaint) for a more streamlined operation. It can be integrated with other processes, such as training control, so training tasks will be invoked as soon as a CAPA is approved.

Under 21 CFR Part 11, FDA-regulated companies that choose to maintain electronic records to meet predicate rules are required to validate their electronic record-keeping systems. OmniGuide will be using MasterControl's detailed, pre-written IQ/OQ protocols and scripts to execute its system validation.

Watch Videos Using MasterControl for FDA Compliance (3:53) MasterControl's Documents Module (2:02)

About MasterControl
MasterControl Inc. has been at the forefront of providing innovative electronic quality management systems since 1993. MasterControl provides a configurable, easy-to-use, and integrated system to help companies effectively manage document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other processes under a single Web-based platform. The company offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. Hundreds of companies use MasterControl to meet stringent FDA requirements, but many others also use it for compliance with ISO standards, Sarbanes-Oxley Act, and other regulations. For more information, visit www.mastercontrol.com, or call 800-825-9117.