PASS Technologies AG
Eichtal 56
CH-8634 Hombrechtikon
Switzerland
phone +41-55 2641243
fax +41-55 2641245



 

IV&V Services&Solutions for Product Quality&Compliance

Services

Compliance Coaching

If you are new in a market where your products have to comply with directives from regulatory bodies such as FDA's 21 CFR 820, the In-vitro Diagnostics Directive (IVDD) or the Medical Device Directive (MDD), our Compliance Coaching helps you through from definition of quality management processes to structuring design history file and submssion documents. PASS consultants can coach your team on-site and remotey, transfer knowledge, provide guidance, supervise and monitor the progress.

System Test Outsourcing

Use the PASS System Test Center  to outsource your system test project or just parts of it. Our test teams integrate seamlessly into your organisation and work according to your processes.

Test PM / Engineer Insourcing

In case you need project management or test resources to for a limited time, our project management consultants and trained / certified test engineers are ready to work with your team on-site.

Off-Shore Test Services

For fast ramp-up of resources in specific test disciplines such as e.g. test automation or regression testing we can provide you together with our Mumbai-based off-shore partner SWQA India (www.swqaindia.com) with well-suited and cost efficient team setups.

GxP Computer System Validation (CSV)

The full validation of software-controlled systems has become a decisive factor in regulatory audits, notably due to 21 CFR Part 11. PASS is offering consulting, planning and implementation of CSV e.g. for integrated systems or plants in the pharmaceutical industry or in forensic applications.

News

June 2009: PASS joins the SiLA workgroup "SiLA Standard Verification and Certification"

May 2009: PASS evaluates and tests MERLIN, the new web based application platform for swiss government funded technology transfer (CTI) projects

January 2009: PASS joins the SiLA industry consortium for standardisation in lab automation.

February 2009: PASS and Axeda cooperate to provide professional validation services to medical device companies implementing Axeda remote services for their installed base.

March 2009: PASS and Xeronics finalize their joint development project ODIS.TRM, a Test Report Automation and Reliability Monitoring Platform Solution