process validation Switzerland

...We plan and perform your complete process validation. From the first gap analysis and risk management, planning, execution and reporting. We support you with full project management, providing support where needed. You free your ressources for your projects, we take care for validations and all connected activities. You reach your goals safely, quicker and faster.

... development process with ISTQB(r) certified testers - Test bench development - Compliance documentation in highly regulated markets (GMP, FDA, UL, etc.) - Support for project-relevant suppliers regarding deadlines, costs, and quality...

... = Atmosphère Explosible (use of systems and/or devices in explosion-risk zones) FDA and GMP As we have already had the opportunity to plan and implement several systems in the food and pharmaceutical sectors, we are familiar with the following quality terms: - Requirement Specification (RS) - Detail Specification (DS) - Design Qualification (DQ) - Installation Qualification (IQ) - Operational Qualification (OQ) - Process Qualification (PQ) - Validation They were part of our contracts.

... engagements with academic research organizations (AROs), biopharmaceutical or medical device enterprises, clinical research organizations (CROs), and independent review committees. We have become expert in the creation, performance, and management of the Endpoint Adjudication process workflows and forms validation, private health information management and compliance, clinical trial and GxP...

... certifications ISO 9001, ISO 13485, TS 16949, and ISO 14001, we are also a competent partner in the automotive and medical industries. In quality assurance, we rely on various tactile and visual testing methods. Sampling under series conditions according to PPAP, customer requirements, and validation specifications (DQ, IQ, OQ, PQ) are supported by our process monitoring (SPC). In our CAQ system (Computer...

...Feasibility, Project Management, Prototyping Management, Engineering, Rapid Prototyping, IoT Solutions, Industry 4.0 Industrial Automation: Project Management, Engineering, Implementation, Validation Pharma, Food: Packaging, Track n'Trace, Serialization, Aggregation Machine Industry: Special Machines, Flow Assembly Lines Aero/Space: Rigs and Fixtures for Structural and Functional Assemblies Robotics with Integrated Quality Inspection for High-Tech Products and Laboratory Automation Data Management Industry 4.0...