The contracted use, users, records, decisions and boundaries for regulated processes must be documented.
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Clinical and quality
Support the work. Keep judgement with accountable people.
Clinical technology assurance begins with intended use, critical processes, reliable records, controlled change and a clear division of responsibility between Tenvia and the customer.
Assurance position
Tenvia will describe how the service supports applicable controls. It will not present 21 CFR Part 11, GCP or GDPR as a simple software badge.
Control register
What buyers need to know.
Statuses distinguish product direction from commitments and evidence for a specific deployment. They are not certification labels.
Control domainCurrent statusPublic position
Factors that are critical to quality, along with assumptions and risks, should remain connected to study design decisions.
Access, audit, approval, record retention and signature requirements are assessed against intended use.
Tenvia provides appropriate supplier evidence. Customers retain responsibilities for their intended use, configuration, procedures and validation approach.
Requirements, testing, approval, release and change evidence are maintained to the level required by the service scope.
Regulatory intelligence provides context with sources attached. It is not legal advice, agency approval or a determination of applicability.
Prospect FAQ
Direct answers for due diligence.
These answers describe the current public boundary. Contracted controls and evidence must match the actual deployment.
Request deeper evidencePart 11 is not a general product certification. Suitability depends on intended use, technical controls, configuration, procedures and customer responsibilities. Tenvia will provide a support and responsibility assessment for the contracted scope.
Evidence room preview
Review sensitive assurance under controlled access.
The index below shows the material a diligence review can request. Scope and availability are confirmed item by item before access is granted.
01Quality system overviewAvailability confirmed in diligenceControlled
02Intended use assessmentAvailability confirmed in diligenceControlled
03Supplier and validation evidence indexAvailability confirmed in diligenceControlled
04Release and change control summaryAvailability confirmed in diligenceControlled
05Shared responsibility matrixAvailability confirmed in diligenceControlled
Security and diligence
Request the right level of access.
Start with a public product review. Add confidentiality when the discussion includes sensitive study or security information.
How access works
01Explore publiclyReview the product using fixture data. No NDA is required.02Discuss confidentiallyPut a mutual NDA in place before sharing study material.03Review evidenceReceive controlled access to the relevant assurance material.
Access is granted only after Tenvia confirms the request, confidentiality route and available evidence.