PASS Services for the Healthcare & Life Sciences Industry
Leading software- and manufacturing corporations, medical device, diagnostics- and biopharma enterprises benefit from our >20 years experience in technical consulting and engineering services:
| Systems Engineering & Systems Integration | Verification & Validation | Consulting |
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Systems Engineering
Developing complex systems efficiently requires utilization of a systematic approach to the system engineering efforts. Knowing what tools and techniques are available as well as how and when they should be applied is critical to success in product development. PASS provides system engineering expertise specializing in areas under very strict regulatory controls, conforming with european and US regulations such as 21 CFR 820 and 21 CFR part 11, Medical Device Directive and In-Vitro Diagnostics Directive IVD 98/79CE.
Areas in which PASS will benefit your system development needs include:
- Requirements Engineering
- Specification Development
- Critical System Design Techniques for Safety, Reliability, and Compliance
- Engineering Tool and Product Selection
- Design for Standards and Regulatory Compliance
Independent Verification & Validation
Use the PASS System Test Center to outsource your software- or system test project or just parts of it. Our test teams integrate seamlessly into your organisation and work according to your processes.
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.
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.
Association Memberships
PASS is an active member of Toolpoint for Life Science association, the swiss industry cluster of leading suppliers of equipment and services to the life science industry.
PASS is a supporting member of the SiLA consortium for Standardisation in Lab Automation, an organisation of instrumentation-, software- and integration services suppliers to the life science lab automation industry and leading pharma and biotech corporations.
