MadgeTech, Inc. Offers On-Site IQ/OQ/PQ Services to Assist Companies with 21 CFR Part11 Compliance
MadgeTech, Inc. offers on-site IQ/OQ/PQ training and services to help users validate their data logging systems. The MadgeTech staff is expertly trained in protocols and proper implementation of IQ/OQ/PQ of MadgeTech data logging systems with minimal disruption to staff and operations.
Some of the key benefits of MadgeTech's IQ/OQ/PQ services include custom protocol generation to fit your application and need, expert recommendations for PQ and ongoing maintenance, and a comprehensive qualification report provided upon completion.
MadgeTech performs extensive product qualification testing prior to releasing new data logging products to the marketplace. This includes independent hardware and software testing as well as integrated testing of the data logger system. In addition to this detailed testing, regulatory agencies still require that the end-user validate the data logging system in the environment that it will be used. This validation process includes installation qualification (IQ), operational qualification (OQ) and ongoing performance qualification (PQ).
MadgeTech 4 Secure Software ensures standards in which electronic files are considered equivalent to paper records, saving time and effort. MadgeTech Secure Software contains criteria such as electronic signatures, access codes, secure data file, and an audit trail which meet the requirements of 21 CFR Part 11 and help provide data integrity.
MadgeTech will consult and tailor the IQ/OQ/PQ services package to fit the needs of the individual. All services are offered based on a daily rate of $1000/day, plus travel expenses. In most cases, only one MadgeTech technician is needed for an implementation. For additional information or to discuss your specific needs further, please visit www.madgetech.com or call (603) 456-2011 to speak with our expert sales and support staff.
