DSRV Stability program / public statement / rev 2026-11-10
Staged by agent, signed by scientist.
We work alongside you. Have your reports on demand instead of digging through messy files.
Agents stage work at 'mapped'. Only a human review and signature make a record official.
A digital stability management system for pharmaceutical laboratories. Supported source files are converted into structured drafts with confidence flags for your review.
Fig. 1 / source file to official record / specimen
One value, traced.
Source file
results-scan.pdf
| Test | Result |
|---|---|
| Assay | |
| Total impurities | |
| Water content | |
| pH |
page 2 of 3
Official record
- Official value
- Assay, 6 months, 99.2 %
- Location
- page 2
- Source file
- results-scan.pdf SHA-256 9c41e7a2…
- Reading
- 99.2 %, as read
- Figure
- 1, one value traced
- Data
- Specimen. Illustrative demo data - not customer, production, accuracy, performance, or validated scientific metrics.
- Studies
- Studies are composed from approved product, specification, and storage-condition libraries, with automatic pull schedules, overdue tracking, and OOS investigations with documented dispositions.
- Pull points
- Overdue and upcoming pulls are flagged for review.
Drawing 1 / five steps, one value
What happens to a value
01 / file
Source file
02 / draft
Draft
Extraction produces lots, timepoints and results, each carrying a confidence flag for human review.
03 / mapped
Review
Agents stage work at 'mapped'. Only a human review and signature make a record official.
04 / signed
Signature
Electronic signature is restricted to Reviewer, Approver and Administrator accounts and requires password re-entry at the point of signing.
The signer is taken from the authenticated session, never from the request body.
05 / official
Official record
Official study results are append-only. Deletion is blocked at the database level.
Corrections are made by append-only supersede chains with one live row per coordinate, never by destructive edit.
Drawing 2 / agent, scientist, administrator
Who does what
01
Agent
Agents stage work at 'mapped'. Only a human review and signature make a record official.
AI-key routes are read-only: the agent namespace cannot sign, commit, approve, activate, close or reject, and those calls return 403.
The agent namespace is confined to read and draft actions.
02
Scientist
Electronic signature is restricted to Reviewer, Approver and Administrator accounts and requires password re-entry at the point of signing.
An official result must reference a committed import event whose packet is signed by the same signature event and belongs to the same study.
03
Administrator
Administrators are blocked from entering or modifying study data, so the person who records a result is never the person who approves it.
Data uploaded by a tenant user is stamped with that tenant on ingest and is not visible to any other tenant.
Notes / approved wording, with the register row and its substantiation
Specification notes
- N1
Tenant isolation is enforced in application code and proven by a two-tenant cross-access test; database-level RLS is staged as defense-in-depth.
row A1
ADR-003 · PILOT-002 - N2
Administrators are blocked from entering or modifying study data, so the person who records a result is never the person who approves it.
row A7
role.ts · route-utils.ts - N3
Official study results are append-only. Deletion is blocked at the database level.
row E1
migrations 0006, 0007 - N4
The audit trail is enforced by database trigger, not best-effort application code.
row E3
migration 0013 - N5
Controlled records are accessed server-side only. The database is never reachable from the browser.
row F1
service role only - N6
The simulator provides a display-only ordinary-least-squares regression estimate to a fixed 90 percent potency limit, and may call a language model to draft explanatory narrative text. It is not an ICH Q1E implementation and does not establish, approve, or officialize a shelf-life claim.
row D1a
simulator route
Validation status / what we can say today
Where the system stands on validation
DSRV Stability is not GMP validated, not 21 CFR Part 11 compliant, not inspection-ready, and not FDA approved.
IQ/OQ/PQ protocols exist as templates and have not been executed. SOPs are draft until approved by a Quality Unit.
If your quality unit needs more
DSRV can execute the IQ/OQ/PQ protocol templates with your Quality Unit as a scoped qualification engagement; ask when you request access.
Ask about qualificationSheet notes / straight answers
Straight answers
- What is the DSRV Stability Program?
- A digital stability management system for pharmaceutical laboratories: studies built from approved libraries, pull-point schedules, OOS investigations with documented dispositions, stability reports, and a display-only regression estimate. It is available through secure, laboratory-specific access.
- What do the AI agents actually do?
- The agent namespace is confined to read and draft actions. Supported extraction paths prepare lot, timepoint, and result data from scans, photos, spreadsheets, and legacy exports as structured drafts with confidence flags for review.
- What boundary applies to AI-key routes?
- AI-key routes are read-only: the agent namespace cannot sign, commit, approve, activate, close or reject, and those calls return 403.
- What kinds of documents can I upload?
- Supported inputs include scanned PDFs, photos of paper records, Excel spreadsheets, CoAs, and configured legacy exports. Extraction depends on source quality and configuration, and the resulting values remain drafts with confidence flags for review.
- Is my data isolated from other customers?
- Tenant isolation is enforced in application code and proven by a two-tenant cross-access test; database-level RLS is staged as defense-in-depth. Agent API keys are scoped per tenant and rate-limited.
- Is the system validated for GMP use?
- DSRV Stability is not GMP validated, not 21 CFR Part 11 compliant, not inspection-ready, and not FDA approved. The Validation Center reports the current lifecycle status of the validation-readiness artifacts.
- What does the shelf-life simulator do?
- The simulator provides a display-only ordinary-least-squares regression estimate to a fixed 90 percent potency limit, and may call a language model to draft explanatory narrative text. It is not an ICH Q1E implementation and does not establish, approve, or officialize a shelf-life claim.
- Can DSRV qualify the system for our use?
- DSRV can execute the IQ/OQ/PQ protocol templates with your Quality Unit as a scoped qualification engagement; ask when you request access. Until then, IQ/OQ/PQ protocols exist as templates and have not been executed.
- How do I get access?
- The program is behind a login and access is provisioned per laboratory. Log in at /app/login if your lab is already onboarded, or request access with the form at the bottom of this page and we'll set up your tenant.
Issue / access is provisioned per laboratory
Get access for your lab
Tenant accounts are provisioned by DSRV during onboarding, not by customer self-registration. Leave a work email and we will follow up.
Already onboarded? Log in to the Stability Program