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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:
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.