Quality & Compliance
One quality system, every batch.
Data integrity is not a policy bolted on at the end. It is how the plant is instrumented, how records are written, and how a batch is released.
Inspections
0
Regulatory inspections passed
Release
0
Batches with electronic records
Deviations
0
Median deviation closure
Standards
What we hold.
GMP certified
Manufacture, packaging and release under current good manufacturing practice.
ISO 13485
A quality management system audited annually against the standard.
Data integrity, ALCOA+
Attributable, legible, contemporaneous, original and accurate, by instrumentation rather than by procedure.
In practice
How that shows up.
Records
Electronic batch records end to end
Every critical parameter is captured by the equipment that produced it, timestamped and append-only.
- 21 CFR Part 11 aligned
- No transcription steps
- Immutable audit trail
Readiness
Inspection-ready, continuously
Documentation is assembled as work happens, so an inspection is a retrieval exercise rather than a project.
- Standing document index
- Annual mock inspections
- Supplier qualification on file
Ask for the quality dossier.
Partners can request the full quality manual and certification pack through the portal.