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% faster QC review
Cut batch record QC review time by up to 50% by automating the first-pass review of completeness, calculations, signatures, and SOP-aligned checks.
~30% more issues flagged
Flag ~30% more issues than manual first-pass review in pilot batch records, including missing signatures, calculation errors, SOP deviations, out-of-range values, and incomplete fields.
Earlier deviation detection
Detect potential deviations earlier by checking batch records against SOP logic, expected ranges, and release criteria before issues escalate to OOS, batch holds, or remediation delays.
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.
Exhaustive QC run record: every check, issue, source page, calculation, and reviewer decision is logged with auditable traceability for inspection readiness.
Specialized QC checkers: dedicated agents for calculations, OOS, signatures, completeness, SOP compliance, and deviation signals work together across long, complex records.