Go paperless without a two-year digitisation programme.
V5 Ultimate replaces the batch record binder, the equipment logbook, the cleaning log, the deviation notebook and the SOP training sheet with one signed electronic record — kiosk-native on the floor, inspector-ready in the QA office, and live in weeks, not quarters.
You searched paperless because the binder is still winning.
Batch records are printed, filled in by hand, scanned, then re-typed into a spreadsheet
Equipment logbooks and cleaning logs live in ring binders no inspector can navigate
Deviations are captured on a paper form, then re-entered into a QMS days later
SOP training is a signature sheet in a folder — you can't prove who was current when
Every 'paperless' RFP so far has quoted 12-18 months and $500k+
The paper is where the transcription errors live — and where the inspector finds them
Everything that was on paper, run as one signed record.
Electronic batch record (eBR / eBMR / eDHR)
Structured, kiosk-native batch record with in-process checks, material scans, deviation branch, bound e-signatures and printed-copy criteria — replaces the printed MBR / batch packet on day one.
Electronic logbooks
Equipment logbook, cleaning log, environmental round, calibration touch — all electronic, all searchable, all audit-trailed. The ring binder retires.
Deviation & CAPA at the point of capture
Operator raises a deviation on the same kiosk running the batch — QA is notified in seconds, root cause and CAPA linked to the batch record, closed inside V5.
Read-and-understood training
SOP issued → user reads and signs → training record bound to signature → expired training blocks the task. No wet-ink sign-off sheet in a folder.
Part 11 + Annex 11 by construction
§11.10(e) audit trail, §11.50 signature manifestation, §11.70 signature-to-record binding, ALCOA+ data integrity — native, not a checklist you retrofit.
Live QA release queue
Batch closes → QA sees a review-by-exception queue with every out-of-spec and every override highlighted → release signature is minutes, not days.
What changes the day this goes live.
- Batch record review-and-release falls from 5-14 days to same-day, often same-shift
- Transcription errors disappear because the shop-floor entry IS the record
- Inspector navigates one file, not five binders — audits shorten by half
- Right-first-time climbs 8-15 percentage points once IPC gates are enforced live
- The 'paperless project' stops being a slide and becomes a signed batch this quarter
Paperless the way an inspector expects to see it.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.
GAMP 5 Second Edition
Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.
See the device-grade equivalent — eDHR, design controls and 21 CFR Part 820 / QMSR.
Paperless manufacturing, answered.
What does 'paperless manufacturing' actually cover?
In V5 it covers every place a regulated plant touches paper: the batch record (eBR / eBMR / eDHR), the equipment logbook, the cleaning log, the environmental monitoring round, the calibration touch, the deviation form, the CAPA workflow, the SOP training sheet and the QA release packet. They're one system, not eight.
How long does a paperless rollout usually take?
First signed electronic batch record on V5 is typically live inside 30 days from kickoff. Retiring the logbooks and training folders is another 30-60 days depending on how many SOPs and pieces of equipment are in scope. There's no 12-18 month bespoke build.
Do we still need to validate?
Yes — but V5 ships GAMP 5 Second Edition / CSA-aligned evidence with onboarding: IQ/OQ documentation, requirements traceability, test scripts and change-control records for the configured product. Your validation team reviews and signs, they don't author from scratch.
What about signed hard copies for the regulator?
V5 emits printed-copy criteria per Annex 11 §8 and Part 11 §11.10(b) — every printed copy is watermarked, versioned and tied to the electronic source. If a customer or regulator still requires paper for a specific submission, it's a one-click controlled export.
Does this work in a small plant, not just Big Pharma?
Yes. V5 paperless is designed for 20-500 person regulated plants — pharma, cosmetics, food, cannabis, medical device, veterinary. Kiosk-native means no per-user desktop, and the pricing follows plant scale rather than seat count.
Retire the binder this quarter.
Free trial. Real batch records. First signed electronic batch in 30 days.