Fig. 0 chamber corridorDSRV Stability program / public statement / rev 2026-09-30
Every pull point,
result and signature,
on one schematic.
A digital stability management system for pharmaceutical laboratories. Supported source files are converted into structured drafts with confidence flags for your review.
Drawing 1 / the study, source record to official result
The system
The signer is taken from the authenticated session, never from the request body.
Source intake
Extraction produces lots, timepoints and results, each carrying a confidence flag for human review.
Study composed
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 due
Overdue and upcoming pulls are flagged for review.
Only a human signature makes a record official
Agents stage work at 'mapped'. Only a human review and signature make a record official.
Electronic signature is restricted to Reviewer, Approver and Administrator accounts and requires password re-entry at the point of signing.
AI-key routes are read-only: the agent namespace cannot sign, commit, approve, activate, close or reject, and those calls return 403.
Drawing 2 / what you see in the application
From scan to signature
The signer is taken from the authenticated session, never from the request body.
01 scan
The source page is read
Supported source files are converted into structured drafts with confidence flags for your review.
02 draft
Rows arrive in the system
Extraction produces lots, timepoints and results, each carrying a confidence flag for human review.
03 sign
A person signs
Agents stage work at 'mapped'. Only a human review and signature make a record official.
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