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.
Before using Tenvia for regulated work, agree what it will be used for, which records matter, how changes are reviewed and who is responsible. The required controls and evidence must be checked for that use.
Public information · Reviewed 19 October 2026
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.
Check which documents are available →
The public examples use sample data. Check what is available for an evaluation and which security and quality documents can be shared before sending sensitive information.
Evidence to review
What your team needs to know.
Use this list to plan your checks. A listed safeguard is something to verify, not confirmation that it is in place or that supporting documents can be shared.
Review areaCurrent statusPublic information
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.
Agree which supplier evidence Tenvia can provide. Customers remain responsible for assessing their intended use, configuration, procedures and validation approach.
Requirements, testing, approval and change records must be established and verified before the agreed production use.
Regulatory information helps teams review a question, with links to its sources. It is not legal advice or agency approval, and does not decide which rules apply.
Common questions
Answers for your supplier review.
These answers describe what is publicly confirmed. Check the agreed safeguards and supporting evidence for the service you plan to use.
Request supporting documentsPart 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.
Documents to request
Ask what evidence is available for your review.
The list below shows documents you may need for a supplier review. We must confirm which are available and can be shared before granting access.
01Quality system overviewCheck availabilityOn request
02Intended use assessmentCheck availabilityOn request
03Supplier and validation evidence indexCheck availabilityOn request
04Release and change control summaryCheck availabilityOn request
05Shared responsibility matrixCheck availabilityOn request
Security & supplier review
A clear path
to your review.
Explore the product, discuss a study or request assurance evidence. Choose the conversation your team needs.
What would you like to review?
01 / Choose your reviewConfidentiality agreement and approved access
Tell us which security, privacy, quality or architecture evidence your team needs to review.
Your review
02 / Describe your prioritiesPlease keep patient information and confidential study documents out of this request.
Submit your enquiry directly through HubSpot.
Tenvia will contact you to follow up.
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