Risk-based CSV to GAMP 5 (2nd edition), EU GMP Annex 11 and 21 CFR Part 11, with ALCOA+ data integrity built in from the start. From Visp in the Valais, on site in running GMP operations across Switzerland.
Any computerised system that creates, processes, stores or transmits GxP-relevant data needs validation. Typical systems from our work:
Every service ends with an audit-proof document, not a recommendation. What you actually receive:
We map your system landscape, assess GxP criticality and assign each system to its GAMP category. The validation scope follows, risk-based instead of blanket.
Outcome: a validation master plan with a justified test depth per system.
We write requirements that are testable, unambiguous and traceable, and tie them to risk and test case through a traceability matrix.
Outcome: an audit-proof URS with end-to-end traceability.
We facilitate and document the risk analyses that justify the test depth: patient risk, product quality and data integrity as the yardstick.
Outcome: documented risk decisions that hold up in an audit.
We write and execute the qualification protocols, with acceptance criteria defined before testing and a clean handling of deviations.
Outcome: executed protocols and a validation report that carries the release.
We check audit trail, access concept and electronic signatures against Annex 11 and 21 CFR Part 11, technically configured rather than merely described in an SOP.
Outcome: a data integrity assessment with gap list and measures.
We anchor impact assessments for updates and build the periodic review so the validated state holds across the system's lifetime.
Outcome: living procedures that maintain the validated state.
System inventory, GxP criticality and GAMP 5 category per system. The validation scope follows.
Roles, acceptance criteria, risk assessment and test scope, aligned with your QA.
URS, functional specification and traceability matrix, then IQ, OQ and PQ with documented results.
Assessment of deviations and release of the system for GMP use.
Change control, periodic review and backup with restore, tested rather than asserted.
Our engineers know the plant behind the system: process control, utilities, monitoring. CSV that fits the real facility, not just the system description.
Vispact is based in Visp, at the heart of the Swiss life-science industry. Short distances in the Valais, on-site work across Switzerland and Germany.
GAMP 5 (2nd edition) calls for engineers who think. We test what carries risk and justify what we leave out, documented and defensible in an audit.
Every requirement is traceable through to its test evidence. That is the standard we hold ourselves to.
CSV is the documented evidence that a computerised system reproducibly does what it is intended to do, and that its GxP-relevant data remains intact across the entire lifecycle. The foundations are GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
All systems that create, process, store or transmit GxP-relevant data: from the process control system through LIMS and MES to Excel applications with GMP relevance. The GAMP 5 categorisation determines how deeply testing goes.
Computer Software Assurance is the FDA's direction of aligning test effort more closely with risk and cutting non-critical testing. GAMP 5 (2nd edition) follows the same idea. In practice CSA does not replace CSV: it is its consistently risk-based form.
Annex 11 is the European framework for computerised systems, Part 11 the US requirement for electronic records and signatures. They overlap heavily on audit trail, access control and signatures; anyone serving both markets tests each topic against the stricter requirement.
With a 30-minute initial conversation, no strings attached. An assessment of your system landscape with GAMP 5 categorisation follows, from which the validation scope and a sound plan emerge. Reply within one working day, straight from engineering.
In the initial conversation we place your starting point: 30 minutes, no strings attached. Reply within one working day, straight from engineering.
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