GREENVILLE, SOUTH CAROLINA -- (Marketwired) -- 05/14/13 -- Global PTM, an industry leader in Maintenance Operational Improvement (MOI) solutions with focused knowledge on Oracle Enterprise Asset Management (Oracle eAM) implementations, developed an integrated solution that allows Oracle customers to perform calibrations in a manner compliant with the FDA's 21 CFR Part 11 electronic signature guidance. The integrated software solution, based on Oracle Workflow and Oracle Fusion Middleware, presents a new opportunity for process optimization in the healthcare, medical device, biotech and pharmaceutical industries.
Global PTM, a Gold level member in Oracle PartnerNetwork (OPN), used its calibration, CFR, Oracle eAM, Oracle Approvals Management Engine, Oracle E-Records and Oracle Quality module expertise to develop integrated processes that allow a medical technology company to eliminate its reliance on manual signatures, spreadsheets and a third-party calibration solution.
"Companies that are on the leading edge of compliance and employing state-of-the-art integration solutions are going with eSignature. There is a tremendous advantage to integrating Oracle Enterprise Asset Management, Oracle Quality, and Oracle Manufacturing, Purchasing and Receiving. It puts all eSignature events into one common data store," says Don Hobbs, Global PTM's Vice President of Oracle Solutions.
Quality, compliance, and timeliness are paramount
Healthcare product concerns necessitate a speedy response because of the health, safety, legal and financial consequences. For instance, if a problem arises with a stent recently placed into a body, not only is that person's health at risk, but others might be as well.
If a product is found to be defective, immediate answers are needed to isolate the root cause and prevent further harm. For example:
-- What was the manufacturing work order for that product?-- What equipment, parts or resources were used in its manufacture?-- What equipment did it run on?-- Who ran the machine?-- Who calibrated the equipment and when?-- What were the various states of calibration compliance of the items?-- Who vouched for compliance?
Ideally, the manufacturer will narrow down the problem to a specific product lot and serial number range, produced on specified dates, so it can notify the doctors and hospitals that received those units and implement a recall. Application consolidation makes this birth-to-death insight possible.
"If physical records are involved, many man hours and dollars will be spent seeking the answers. If the system of record is the Oracle E-Business Suite but a third-party calibration product is used, then either an interface is needed or audits of the third-party solution will be required. But when all eSignature events take place in a common system, the answers are readily available in a 'single source of truth,'" says Hobbs.
About Global PTM
Global PTM, a subsidiary of VIZIYA Corporation, is headquartered in Greenville, South Carolina. The company delivers Maintenance Operational Improvement (MOI) solutions centered around Oracle eAM implementations designed to enhance maintenance effectiveness and asset performance for Fortune 1000 and governmental organizations. Global PTM's deep maintenance process best practices knowledge combines with a proprietary methodology for software implementation, configuration and training, to produce sustainable results for clients: improved maintenance labor efficiency, optimized MRO inventory, and, ultimately, greater asset performance, reliability and longevity. For more information, visit www.GlobalPTM.com.
About Oracle PartnerNetwork
Oracle PartnerNetwork (OPN) Specialized is the latest version of Oracle's partner program that provides partners with tools to better develop, sell and implement Oracle solutions. OPN Specialized offers resources to train and support specialized knowledge of Oracle products and solutions and has evolved to recognize Oracle's growing product portfolio, partner base and business opportunity. Key to the latest enhancements to OPN is the ability for partners to differentiate through Specializations. Specializations are achieved through competency development, business results, expertise and proven success. To find out more, visit www.oracle.com/partners.
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Don R. Hobbs