Controlled document acknowledgement — signed proof of read-and-understood for every SOP revision.
ReadSignFlow gives quality teams controlled document acknowledgement: distribute SOPs, work instructions, and quality manuals, enforce a read gate, and capture version-specific read-and-understood signatures that support ISO 9001 clause 7.5 and GxP read-and-understood expectations. Automatic reminders and manager escalations chase outstanding operators, and when a new revision is released the re-acknowledgement runs again for the affected segment. One click exports the audit pack — signed PDFs plus an append-only event log — for your next certification or customer audit.
ISO 9001 clause 7.5 and GxP both expect you to prove the current revision was read and understood — not just filed. ReadSignFlow distributes your controlled documents to every operator, inspector, and supplier contact, gates the signature behind the document itself, and re-runs the acknowledgement automatically when a revision lands.
Read-and-understood is a QMS clause, not a courtesy.
- 01 — Every revision resets the clock. Rev C goes effective and yesterday's training matrix is obsolete. Spreadsheets can't tell you who signed Rev B but never saw Rev C — your acknowledgement records have to be revision-aware, or they're worthless.
- 02 — The audit-day sampling scramble. The auditor pulls one SOP at random and asks who has read the current revision. If the answer lives in wet-ink sign-off sheets, shared drives, and email threads, you're assembling evidence while the finding gets written.
- 03 — Clipboards don't reach the shop floor. Operators and inspectors don't sit in Outlook. The laminated read-and-understood sheet on the noticeboard collects illegible initials, missing dates, and no proof anyone opened the actual document.
Eight quality workflows, one controlled system.
Every read-and-sign loop your QMS demands — from revision-triggered re-acknowledgement to supplier quality packs — with version-stamped evidence on each one.
- SOP read-and-understood on every revision — Publish Rev D, retire Rev C, and launch a re-acknowledgement to only the affected lines and roles. Each record stores the exact revision signed — a compliance tracking system where 'trained on current version' is a filter, not a hunt.
- Quality manual & quality policy rollouts — Push the re-issued manual to every site in up to 5 recipient languages — policy compliance software with the read gate on the document itself, so no more 'signed the sheet, never opened the manual'.
- CAPA-driven procedure updates — When a corrective action reissues a work instruction, the signed acknowledgement from every affected operator becomes part of your effectiveness evidence — dated, per person, per revision.
- Calibration & inspection procedure sign-off — New sampling plan, revised accept/reject criteria, out-of-tolerance notices — route them to inspectors and lab techs with per-recipient deadlines and escalation to the lab supervisor.
- Supplier quality requirement acknowledgements — Send supplier quality agreements and requirement packs to external contacts over an email magic link — no account needed — and keep the signed acknowledgement on file per supplier for source audits.
- Non-conformance follow-up acknowledgements — After an NCR or 8D closes, confirm the operators involved have read the disposition and the revised control before they run the process again — with proof the reading happened.
- Pre-audit refreshers — Two weeks before the surveillance audit, re-circulate the procedures your auditor sampled last cycle and walk in with fresh, dated acknowledgements instead of last year's binder.
- New-operator qualification packs — An always-on onboarding campaign assigns HRIS-synced joiners the quality manual extract and the SOPs for their role on day one — chased automatically until every document is signed.
What quality teams actually route for signature.
The revision-controlled SOPs, CAPA reissues, and system documents that need a dated read-and-understood signature from everyone on the distribution list.
CAPA & quality alerts
- CAPA-driven SOP and work-instruction reissues
- Quality alerts & stop-ship notices
- Customer complaint / 8D outcome briefings
- NCR disposition follow-up acknowledgements
Controlled procedures
- SOP & work-instruction revisions (read & understood)
- Inspection & test procedure updates
- Calibration procedures & out-of-tolerance notices
- Control plan & PFMEA change notifications
System & supplier documents
- Quality manual & quality policy rollouts
- Supplier quality agreements & requirement packs
- GxP / data-integrity policy attestations
- Pre-audit refresher bundles (ISO 9001, IATF 16949)
Built around the clauses your QMS answers to.
Version-aware acknowledgements, retention policies, and audit pack exports that map to the documented-information and training-evidence requirements in your certification standards.
Frameworks covered: ISO 9001:2015 (clause 7.5), ISO 13485:2016, IATF 16949, AS9100D, FDA 21 CFR Part 820 / QMSR, FDA 21 CFR Part 11, EU GMP — EudraLex Vol. 4, EU GMP Annex 11, ICH Q10, EU MDR 2017/745, ISO/IEC 17025, MHRA GxP Data Integrity Guidance, BRCGS & SQF (GFSI), FDA 21 CFR Part 211 (cGMP).
Frequently asked questions
Can ReadSignFlow track SOP read-and-understood on every revision?
Yes — that's the core workflow. Documents live in versioned folders; when you publish Rev D you launch a re-acknowledgement campaign to just the affected segment (line, site, or role), and each person's record stores exactly which revision they signed and when. 'Who is trained on the current version of SOP-105?' becomes a filter, not a spreadsheet hunt — and the read gate means nobody signs without opening the document first.
How do new operators get their qualification pack automatically?
Through JML auto-enrolment. Sync joiners from your HRIS (or via REST API / CSV import) and an always-on onboarding campaign assigns the pack — quality manual extract, GMP hygiene rules, the SOPs for their role — the day they appear, each with a per-recipient deadline. Automatic reminders at T-7, T-3, and T-24 hours chase the operator, then the platform escalates to their line supervisor.
What evidence do I get for an ISO 9001 or GxP audit?
A one-click audit pack: a signed PDF per acknowledgement capturing signer identity, intent, a UTC timestamp, and the exact document version, plus an append-only event log of every send, open, read, reminder, and signature. Signatures are aligned with eIDAS (EU/UK) and the US ESIGN Act / UETA. When the auditor samples a specific SOP, you filter to that document and revision and export the pack on the spot.
How much rollout effort does this take for a small quality team?
Days, not a validation project. Upload the controlled PDF, sync or import your people, build segments by site, line, or role, set the deadline, and send. Operators without a company email sign via a magic link over SMS, WhatsApp, or a QR poster at the workstation — no app, no passwords. The Free tier covers up to 20 employees, so you can pilot on a single SOP revision before rolling out.
Is ReadSignFlow an eQMS — does it author documents or manage CAPA workflows?
No. ReadSignFlow doesn't author or approve documents and it isn't a CAPA or nonconformance management system. It does one job to audit grade: distribute the released revision, enforce the read gate, capture the acknowledgement, chase and escalate, and keep the evidence. Keep authoring and approval in your existing DMS or eQMS, and use the REST API and HMAC webhooks to trigger an acknowledgement campaign when a revision is released and pull completion status back.
Product · Pricing · Security · Solutions · Resources · Book a demo