Our home ground is live GMP operations: pharma, biotech and API production are our daily business. We support medical devices and the life sciences supply chain with the same rigor, from ISO 13485 to GDP.
Authorities inspect, customers audit: your documentation must withstand both. That is the state we work towards.
Fig. 01 · Production hall
Illustrative image
Operational engineering, qualification and validation know no modality boundary. What counts are the facility, the process and the standard behind it. An overview of the environments we work in on site.
This is where our daily work happens: in the cleanroom, at the utilities, in live operations. We know the rhythm of a production that must not stand still, and the rules it runs by.
The 2022 revision demands a Contamination Control Strategy that is lived in operations. We translate it into airflow design, equipment and audit-proof evidence.
PW, WFI, cleanroom air and compressed gases carry every batch. We qualify these systems across the entire lifecycle and keep the qualified state evidenced.
Audit trails, raw data, archiving: electronic records must hold up to ALCOA+. We assess systems and close gaps before an inspection finds them.
The qualified state is not an archive piece: we plan requalification and periodic review so that the evidence keeps pace with operations.
API production combines chemistry at scale with GMP without pause. In this environment we deliver operational plant engineering: at the equipment, in live operations.
Modifications and optimizations must jeopardize neither quality nor output. We run them through change control, cleanly planned and with audit-proof documentation.
From FAT and SAT to integrated C&Q to ASTM E2500: we qualify risk-based to ICH Q9 and hand over audit-ready to operations.
Control systems and automation fall under GAMP 5. We validate risk-based, leverage the supplier's documentation and test what is genuinely critical.
Steam, cooling, compressed air, exhaust air: utilities carry production. We qualify them risk-based and keep the evidence current in live operations.
Our origins lie in GMP operations, and our craft holds up under ISO 13485 and MDR as well. Qualification, validation and documentation follow the same logic here: risk-based, traceable, audit-proof.
Where the output cannot be fully verified, ISO 13485 requires process validation. We plan it risk-based and see it through to the report.
Production and test equipment need an evidenced qualification status across the entire lifecycle. We keep it documented and auditable at all times.
Computerized systems in the QMS must be validated and their data managed to ALCOA+. We work to GAMP 5, including 21 CFR Part 11 where the US market is involved.
Inspection and measuring equipment needs demonstrated suitability and traceability. We bring equipment management and evidence to an audit-proof state.
GDP extends good manufacturing practice beyond the factory gate: warehousing, transport, cold chain. We bring the qualification and validation logic from production to wherever your goods are on the move.
Cold rooms, vehicles and shipping containers need temperature mapping and an evidenced qualification status. We plan the measurement and deliver audit-proof documentation.
The storage zone is qualified, the monitoring system validated: we keep these terms rigorously apart. That is how temperature data remains reliable to ALCOA+.
Transport is a process and is validated: worst-case routes, summer and winter profiles. We run the validation from protocol to report.
Excursions happen: what matters is the documented assessment of the impact on the goods. We define limits, responsibilities and the review path for the event.
Our office sits in one of Europe's most significant life sciences production hubs. We operate across Switzerland and Germany: on site at the equipment, not from a distance.
Vispact GmbH · Visp in Valais, Switzerland
GxP engineering and validation for life sciences: qualification to Annex 15, CSV to GAMP 5, data integrity to ALCOA+. From Visp in Valais, for Switzerland and Germany.
Vispact GmbH · Mondstrasse 6b · 3930 Visp · Switzerland · UID CHE-160.105.904
info@vispact.swiss