Modules
Lab Samples
QC sample tracking, testing workflows, and result management
Lab Samples
Track quality control samples from collection through testing to final determination.
Sample Types
| Type | Description | Testing |
|---|---|---|
| In-process | Sampled during batch compounding | pH, visual, weight |
| Finished product | Sampled from completed batch | Sterility, endotoxin, potency |
| Stability | Sampled at defined intervals | All release tests at each time point |
| Environmental | From EM program | Viable counts (separate module) |
| Water | From water system | Conductivity, TOC, micro |
Sample Lifecycle
Collected <Icon name="ArrowRight" size={12} /> Submitted to Lab <Icon name="ArrowRight" size={12} /> Testing <Icon name="ArrowRight" size={12} /> Results Entered <Icon name="ArrowRight" size={12} /> Reviewed <Icon name="ArrowRight" size={12} /> Passed/FailedTesting Workflow
- Sample collection during or after batch compounding
- Submission — sample logged with batch reference, test requirements
- Testing — internal QC lab or external contract lab
- Result entry — raw data entered with method reference
- Review — QC Technician enters, QA Manager reviews
- Determination — pass/fail based on specification limits
Business Rules
| Rule | Description |
|---|---|
| L1 | Batch cannot be released until all required samples are passed |
| L2 | Sterility test results required for all CSP batches |
| L3 | Endotoxin limits enforced per product specification |
| L4 | Failed samples trigger automatic deviation creation |
| L5 | Out-of-Specification (OOS) investigation required before re-test |
| L6 | Sample retention: minimum 3 years per regulatory requirements |
External Lab Integration
For tests sent to contract laboratories:
- Track send date, expected turnaround, lab name
- Result upload when received (PDF report + data entry)
- COA verification by QA before acceptance
- Turnaround time tracking for lab performance metrics