Batch records are the regulatory backbone of life sciences manufacturing, and their quality control remains a complex process prone to human error.
Biolevate bridges this gap with an assisted BRQC solution that assists page-by-page reviews, verifying calculations, signatures, and SOP compliance.
By flagging more mistakes than the human eye, it drastically reduces audit risks and saves massive amounts of time thanks to a guided user path while keeping exhaustive read and traceability.
50% time reduction
Automate the first review layer to cut batch record QC cycle time by ~50% while keeping exhaustive, SOP-aligned checks.
30% audit risk reduction
Flag ~30% more issues than manual review on average, reducing non‑compliance risk and strengthening inspection readiness.
Early drift detection
Detect emerging deviations earlier by continuously checking records against SOP logic and expected ranges — before issues escalate to OOS or batch holds.
How it works
1
Ingest SOPs and reference standards - centralize site SOPs, specs, and known rule sets so Biolevate can interpret requirements and expected ranges with version control.
2
Run assisted, page-by-page QC - Biolevate guides reviewers through each page/section of the batch record and checks completeness against SOP requirements.
3
Verify calculations, OOS, and signatures - automatically recompute critical calculations, flag out-of-range values and inconsistencies, and validate signature/approval logic with traceable findings.
4
Produce an auditable QC run record - generate a structured issue log and evidence-backed run record to support remediation, release decisions, and inspection readiness.
Run record for exhaustive reading: every check and finding is logged with auditable traceability for inspection readiness.
Multi-agent collaboration: specialized checkers (calculations, OOS, signatures, SOP compliance) work together across long, complex records.