February 2008 – Computerized collection of information allows for electronic signatures, enables rapid document retrieval, eliminates reporting errors and meets quality assurance requirements for regulated industries.
LANSDALE, PENNSYLVANIA— Integrated Service Solutions, Inc. announced today their new electronic calibration database. This paperless document workflow was designed to meet the demands of major pharmaceutical companies to help reduce costs associated with mandatory equipment calibration while simultaneously help to increase efficiencies.
The validated software program was developed by the internal IT staff at Integrated Service Solutions, Inc. and is in full compliance with the Food and Drug Administration (FDA) 21 CFR Compliant 11 regulations ensuring life science companies the ability to use electronic records and signatures.
In making the announcement, Joseph Uricchio, President/CEO, said, “The switch from paper-based records to electronic documents comes after nearly one year of Beta testing by our Metrology Laboratory and field calibration technicians. This paperless reporting provides for better equipment traceability, is fast and secure, provides for complete and accurate reporting and is environmentally-friendly since it requires no printing or physical storage of paperwork. In addition, it meets our ISO 9001:2008 requirements to continuously evaluate and improve our systems and the services we provide to our customers.”
Integrated Service Solutions outfits its field personnel with sophisticated test and measurement equipment as well as laptops equipped with wireless data cards. This set up enables the technicians to electronically transmit all test data at the end of each job thereby guaranteeing the customer a complete electronic data set. In addition, the Company retains a copy of the electronic files in the event of an FDA audit.
About Integrated Service Solutions, Inc.
The largest independently owned services provider, Integrated Service Solutions, Inc. provides comprehensive service solutions to more than 200 pharmaceutical and biotechnology companies across multiple technologies including:
- On-site Equipment Calibrations
- Metrology Laboratory Calibrations
- Preventive/Corrective maintenance
- Protocol Development and Implementation (IQ/OQ/PQ)
- Engineering, Project Management
- Training and Consulting Services
Integrated Service Solutions, Inc., founded in 1998, employs a staff of nearly 60 full-time employees including degreed engineers, chemists, trained field service technicians, operations, client relations, business development and customer service. The Company is conveniently located in the heart of pharmaceutical alley and within easy distance to Philadelphia, New York, New Jersey, Maryland and Delaware.
In the Spring of 2007, Integrated Service Solutions, Inc. relocated to a contemporary, company-owned facility. This 20,000 sq. ft. brick and glass structure is located within a ¼ mile of the Lansdale Interchange of the Pennsylvania Turnpike. The custom designed facility houses an environmentally controlled Metrology Laboratory outfitted with the very latest in sophisticated test and measurement devices, media-rich training and conference rooms, and custom-designed work areas for customer service, business development, and marketing and technical service departments.