Pharmaceutical
Stability testing, dissolution, potency assays — pharma labs need structured data entry with traceability. Aliquora provides a practical platform for managing test data and generating reports.
What Aliquora handles for Pharmaceutical
- Track stability, dissolution, and potency samples
- Out-of-spec detection with configurable specification ranges
- Password re-confirmation during approval steps
- Audit logging for data entry, edits, and approvals
- PDF reports with detailed test results and specifications
How it works
A typical pharmaceutical workflow in Aliquora
- 1
Create the sample with protocol context
Register the sample with its drug product, dosage form, batch number, and test type (stability pull, dissolution, potency, identity). For stability studies, include the time point and storage condition so every pull is linked to its protocol.
- 2
Configure specification ranges
Each test has a configured acceptance criterion — a min/max range, a target ± tolerance, or a 'not less than' limit. Specifications are set at the test-type level and applied consistently across every sample that uses them.
- 3
Enter analytical results
Analysts enter individual replicate readings or final calculated values. Aliquora evaluates each entry against the specification and immediately raises an out-of-spec flag if a value falls outside the acceptance criteria.
- 4
Document the OOS investigation
Flagged results trigger an investigation step. The analyst records the phase (Phase I lab error check or Phase II full investigation), the root cause finding, and the outcome — retest, confirmed failure, or invalidation with justification.
- 5
Approved release with password re-confirmation
The reviewing analyst authenticates with their password before signing off on results, providing an electronic acknowledgment of the data they are approving. All approvals are timestamped and tied to the approving user's identity.
Aliquora's immutable audit log records every data entry, edit, and approval with a timestamp and user ID — supporting the data integrity and audit trail requirements described in FDA 21 CFR Part 11 and ICH Q10 pharmaceutical quality system guidance. Note: full 21 CFR Part 11 compliance requires a validated system; consult your quality team before use in a regulated environment.
Frequently asked questions
- How does Aliquora handle 21 CFR Part 11 requirements?
- Aliquora provides an audit log of all data entries, edits, and approvals with timestamps and user identities, and uses password re-confirmation for approval steps. Full 21 CFR Part 11 compliance requires system validation — consult your quality team before using Aliquora in a regulated submission context.
- Can we manage stability study time points?
- Yes. Stability samples can be registered with their time point and storage condition (e.g. 25°C/60% RH at 6-month pull) as part of the sample record. Results for each time point are tracked separately and available for review together.
- What happens when an OOS result is confirmed?
- A confirmed OOS result is logged with the analyst's investigation notes and outcome. The sample remains flagged in the system, providing a permanent record of the failure and the disposition decision.
- Can we generate reports for batch record packages?
- Yes. Aliquora generates PDF reports listing all test results, specification ranges, individual values, and the approving analyst — suitable for inclusion in batch record documentation.
Related reading
Other lab types
See how Aliquora works for Pharmaceutical
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