GLP and GCP evidence at every study touch point.
Contract research organizations run study-grade equipment under FDA 21 CFR Part 58 (GLP) and ICH GCP. Sponsors audit. Inspectors visit. The lab is study-keyed; most CMMS systems are asset-keyed; the reconciliation between them is the project. Wēlr is the lifecycle record across analyzers, freezers, balances, and clinical infusion equipment — scoped per sponsor, per study, per protocol.
Four pains that show up in sponsor audits.
- 01
Sponsor audit requests want evidence across studies, not assets.
Sponsor walks in. They want evidence on every instrument that touched Study 1842-A. Your CMMS is asset-keyed. Cross-cutting an audit request takes a week.
- 02
Equipment qualification is duplicated per study.
The same analyzer is requalified for each sponsor's protocol. Qualification work that should be shared isn't — the system doesn't model studies, so each sponsor's qualification posture is rebuilt from scratch.
- 03
Sponsor-specific data scoping is enforced by training, not by architecture.
Sponsor A's data shouldn't be visible to Sponsor B's audit team. Most systems enforce this by user training. The platform doesn't know that a record belongs to Study X for Sponsor Y.
- 04
Calibration excursions surface after study close.
Drift on a critical balance is found at the next scheduled check. The studies that ran in between move into investigation — and the sponsor finds out from your CAPA, not from your monitoring.
Four primitives. One study-aware record.
Study-aware equipment record
Every service event, calibration, qualification check, and method-validation package is scoped to the studies and protocols it touched. Sponsor audits become a study-keyed query — not a CMMS-to-study reconciliation project.
Per-sponsor data scoping (architecturally enforced)
Sponsor, study, and protocol attributes on every record. Access decisions made at the database row, not at the application layer. Sponsor A's audit team cannot see Sponsor B's data — full stop, at the data layer.
Continuous metrology surveillance
Calibration drift on critical instruments — balances, pH meters, freezers, incubators — surfaces as immutable alerts at the moment of excursion. Affected studies are bounded automatically. The sponsor finds out from you, before they find out from the data.
Cross-study audit export (GLP, GCP, ISO 17025)
Sponsor asks; inspector asks; the export builder produces the study-scoped or framework-scoped packet on demand. Same underlying data; four presentation modes.
Why not stitch a CMMS, an LIMS, and per-study spreadsheets?
Most CROs run a CMMS for equipment, an LIMS for samples and runs, and per-study spreadsheets to map between them. Three systems. Sponsor walks in. The mapping is the audit.
| Capability | Wēlr | CMMS + per-study spreadsheets | LIMS-extended LabWare · STARLIMS · LabVantage | Paper / e-DMS |
|---|---|---|---|---|
| Study-scoped audit packet | Query, on demand | Reconciled from sheets | Sample-side only | Multi-week project |
| Architectural data scoping per sponsor | Row-level access control | User-training enforced | Tenant model, sample-only | Folder-level |
| Calibration excursion → affected studies | Bounded automatically | Manual reconstruction | Not modeled | Manual |
| Qualification shared across studies | First-class model | Duplicated per study | Sample-only | Duplicated |
| GLP + GCP + ISO 17025 export from one model | Same data, three exports | Three reconciliations | Sample-only | Three binders |
Study-scoped equipment evidence, sealed and exported in minutes.
The sponsor's audit team walks in. They want every piece of equipment evidence that touched Study 1842-A — every calibration, every service event, every method-validation revision, every Westgard run, every freezer temperature excursion. Wēlr produces that packet as a query, scoped to the study, with no other sponsor's data anywhere near it.
- Per-study scoping enforced at the database row
- Sealed export · 7-year (GLP) / 10-year (clinical) retention
- Cross-study reuse — shared qualification, not duplicated
- Continuous monitoring → bounded study impact at excursion time
If any of these are true, we should talk.
- ✓Your last sponsor audit took longer than five business days to assemble equipment evidence for the studies in scope.
- ✓Sponsor-specific data scoping is enforced by user training, role assignments, or folder-level access — not at the database row.
- ✓The same analyzer or balance has been requalified independently for two or more sponsors in the last 12 months.
- ✓A calibration excursion required you to identify affected studies retrospectively — and the answer took more than a day.
- ✓You produce GLP, GCP, and ISO 17025 audit packets from the same underlying data, manually, in different presentations.
A small founding cohort is shaping Wēlr for contract labs & cros.
Founding partners get preferential pricing, a direct line to engineering, and meaningful influence over the Pharma & life sciences roadmap. Limited to a small cohort per vertical.
- Preferential pricing
- Direct line to engineering
- Roadmap influence
- Limited cohort
Ready to stop stitching service evidence together?
If your team is juggling PDFs, support packages, work orders, customer updates, and QA evidence across five systems, Wēlr is worth a look.
Welr LLC · Delaware