ISS News, Articles & Events

New Electronic Calibration Database

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
  • Certifications
  • Qualifications
  • Validations
  • 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.

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ISO/IEC 17025:2005 Earned

July 2007 – A2LA has accredited Integrated Service Solutions, Inc. for technical competence in the field of Calibration

LANSDALE, PENNSYLVANIA— Integrated Service Solutions, Inc. announced today their accreditation by A2LA for ISO/IEC 17025:2005. While there are many commonalities with ISO 9001:2000 which the Company has held for the past three years, ISO/IEC 17025:2005 applies directly to Metrology Laboratories that produce testing and calibration results.

In announcing the accreditation, Manny Cabanas, Director of Quality Assurance, said, “accreditation under an ILAC (International Laboratory Accreditation Cooperation) recognized Registrar ensures us a ‘no questions asked’ status among world class calibration providers, and enables us to meet the needs of our GMP Clients for ‘competent’ & ‘professionally’ rendered services. We are setting the bar higher, by this level of Accreditation.”

Certification to the prestigious ISO/IEC 17025:2005 is directly related to the quality management system within a laboratory. A prerequisite to qualification is to have a documented quality management system already in place. The comprehensive assessment conducted by The American Association for Laboratory Accreditation (A2LA) addressed the competence of the staff, an inspection of the facility, a review of calibration procedures, analysis of traceability and an appraisal of the methodologies used as well as the calibration equipment.

Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results and since the standard is about competence, accreditation is a formal recognition of that competence.

Accreditation by nationally recognized organizations provides customers with confidence in calibration reports and traceability. In addition, an unbiased assessment of a laboratory’s standards and procedures provides an impartial viewpoint as to how a laboratory functions.

About Integrated Service Solutions, Inc.

The largest independently owned services provider, Integrated Service Solutions, Inc. provides comprehensive service solutions across multiple technologies including:

  • On-site Equipment Calibrations
  • Metrology Laboratory Calibrations
  • Preventive/Corrective maintenance
  • Certifications
  • Qualifications
  • Validations
  • Protocol Development and Implementation (IQ/OQ/PQ)
  • Engineering, Project Management
  • Training and Consulting Services
  • Parts Procurement and much more

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.

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ISO 9001:2000 Triennial Assessment Audit by UL

July 2007— Integrated Service Solutions, Inc. Successfully Completes ISO 9001:2000 Triennial Assessment Audit by UL

LANSDALE, PENNSYLVANIA — Integrated Service Solutions, Inc. announced today that they have successfully passed ISO 9001:2000 Triennial Assessment Audit by UL. Every three years, all ISO registered companies must undergo and pass a complete audit of their Quality Management System in order to continue their registration.

Certification to the prestigious ISO 9001:2000 standard requires a comprehensive assessment and audit ensuring that the company maintains the proper procedures and processes for a complete quality system. Only after stringent third-party assessment can ISO registration be received. The ISO 9000 series standards are internationally recognized quality management system requirements developed by the International Organization for Standardization (ISO). These standards put great emphasis on quality commitment by top management and all employees. To ensure compliance, Underwriter’s Laboratories (UL) performed an on-site assessment of the Company’s documented procedures and survey its overall operations.

The successful completion of the Triennial Assessment Audit was due in large part to the ongoing and sustained efforts of the employees of Integrated Service Solutions, Inc. to continually improve the Quality Management System. Highlights of the audit include comments such as:

  • Excellent records in all areas
  • High levels of top management
  • Customer satisfaction at 98%
  • Low turnaround time for service provision
  • Strong processes to control service provision and equipment calibration

About Integrated Service Solutions, Inc.

The largest independently owned services provider, Integrated Service Solutions, Inc. provides comprehensive service solutions across multiple technologies including:

  • On-site Equipment Calibrations
  • Metrology Laboratory Calibrations
  • Preventive/Corrective maintenance
  • Certifications
  • Qualifications
  • Validations
  • Protocol Development and Implementation (IQ/OQ/PQ)
  • Engineering, Project Management
  • Training and Consulting Services
  • Parts Procurement and much more

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.

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