Compliance software built for
the audit you didn't schedule.
ValiCore replaces the Excel trackers, paper logbooks, and email threads that Indian pharma manufacturers, CROs, and labs rely on today — with a single system that produces an inspection-ready record on demand, not after three days of reconstruction.
What is pharma compliance software?
Pharma compliance software is a system of record for every GxP-regulated activity in a manufacturing plant, lab, or CRO — calibration, QC testing, deviations, CAPA, change control, document control, training, and batch release — with the controls regulators actually check for: a computer-generated, time-stamped audit trail (21 CFR Part 11 §11.10(e)), unique electronic signatures tied to individuals (never shared logins), and version-controlled documents that can't quietly go out of date. It's the difference between telling an inspector 'we have a process' and showing them the timestamped, unbroken record that proves it.
Built for
What goes wrong without it
The 200-open-CAPA problem
Fragmented CAPA records across spreadsheets and email threads can't produce a clean status report on demand. When the inspector asks 'show me your open CAPAs,' a scramble is the wrong answer — and a documented, unavoidable 483 is often the result.
Outdated SOPs on the floor
Without version control, operators keep working from a superseded SOP long after it was revised. This is one of the most common findings in GMP inspections — and one of the easiest to prevent with a locked, single-source document register.
Records that can be silently edited
A spreadsheet has no audit trail. Anyone with edit access can change a result and no record of the change survives. Under 21 CFR Part 11 and Schedule M, that's a data-integrity violation the moment an inspector notices it.
What ValiCore actually does here
Tamper-evident audit trail
Every create, update, and e-signature event is hash-chained and independently verifiable — not a log that can be edited after the fact.
21 CFR 211.68 · §11.10(e)21 CFR Part 11 e-signatures
Unique per-user signatures with a captured meaning (approved, reviewed, rejected) — never a shared login standing in for accountability.
21 CFR Part 11 Subpart CCAPA with effectiveness checks
Root cause, corrective action, and a mandatory effectiveness check before closure — so a CAPA can't be marked done without proof it worked.
ICH Q10Document control with version lock
Superseded SOPs are automatically retired from active use. Operators only ever see the current, approved version.
21 CFR 211.180OOS/OOT investigation workflow
Phase 1 (lab) and Phase 2 (manufacturing) investigation stages, with the FDA's 2022 timeline benchmarks built into the workflow.
FDA OOS Guidance, Rev. 1 (2022)Batch record & release e-signatures
Electronic batch records with role-gated release e-signatures — only a Qualified Person can certify release.
21 CFR 211.165Regulations this addresses
Related modules
Frequently asked questions
Not on its own. Excel has no built-in, tamper-evident audit trail, no enforced access control tied to individual users, and no locking mechanism to prevent silent edits. Some organizations attempt narrow validation for calculation-only use, but as a system of record for GxP data, an unmodified spreadsheet doesn't satisfy §11.10(e)'s audit-trail requirement or the access-control expectations regulators check for.
A generic eQMS (used across manufacturing, automotive, aerospace) treats pharma as one vertical among many, and its out-of-the-box workflows often need heavy reconfiguration to match how a GMP quality system actually runs. Pharma-specific compliance software is built around the regulations from day one — CAPA effectiveness checks, OOS phase-gating, Part 11 e-signatures, and Schedule M's PQS/QRM/PQR structure aren't add-ons, they're the default.
ValiCore targets a 14-day go-live: system setup and configuration in the first 48 hours, calibration/QC/document data migration over days 2–7, and team training with final sign-off by day 14. We guarantee this timeline or extend implementation at no extra cost.
Yes. Our Import Center accepts CSV/Excel uploads for equipment, calibration, QC, users, SOPs, suppliers, and training, with downloadable templates and a dry-run validation mode. Complex historical migrations are scoped during your demo.
See ValiCore
live in your lab.
Book a free 30-minute demo. We’ll walk through the modules your team will use, answer your compliance questions, and give you a clear picture of what implementation looks like for your lab.
Book your free demo
30 minutes. No credit card. We’ll respond within 4 business hours with a calendar invite tailored to your time zone.
Book my free demo35 working modules · Founder-led onboarding · 14-day go-live guarantee