Six gated phases. Customer QA owns sign-off. V5 delivers evidence, installer, training and a named implementation lead — from discovery through steady state across every site, every region, every inspector.
Each phase has explicit exit criteria signed by Customer QA. No phase starts until the previous one closes. Typical programme runs 6–12 months for a 3–5 site enterprise.
Statement of work, site inventory, regulatory scope (e.g. 21 CFR 210/211, 820, ISO 13485, EU MDR/IVDR, MDSAP, BRCGS, SQF, FSMA 204, ISO 22716, MoCRA, GACP/GMP cannabis), integration map with existing eQMS/MES/PLM/ERP/LIMS, and a countersigned validation strategy. Named exec sponsor and steering committee stood up.
Installer signed and delivered. Customer IT executes install per §13 of the on-prem spec. IQ signed, OQ template countersigned, sandbox live with your master data, recipes/BMRs or DMRs. Key users trained on core workflows.
OQ executed and countersigned on one production line. PQ plan approved by Customer QA. Line goes live under hypercare. All evidence lands in the auto-assembled validation pack — you sign, we don't.
Role-based curriculum (operator, supervisor, QA reviewer, admin). Written, practical and teach-back certification. Certified internal trainers roll out to remaining sites. SCORM/xAPI exports land in your LMS; re-cert annually or on master-record revision.
30–45 days per site. Local IQ, OQ and PQ using the countersigned templates. Site go-live with 2-week hypercare. Regional QA owns approvals; V5 provides the implementation cell and escalation path.
Quarterly business reviews, release cadence aligned to your change board, monthly hypercare KPIs, and 24/7 named escalation. Regulator or notified body access on request. SaaS subscription includes validated patches and regulatory updates (Part 11, Annex 11, evolving standards) — no separate Maintenance & Support line. On-premises deployments renew Maintenance & Support annually for the same updates plus IQ/OQ pack refreshes.
Enterprise IT teams get the signed installer, Ed25519 signature, SHA-256 checksum, preflight script, IQ pack, SBOM and per-environment activation keys. V5 does not sign your OQ — you own validation in your environment.
V5 lead + Customer PM + QA + IT. Working session, blockers, evidence review.
Exec sponsors, programme director. Phase gate decisions, risk log.
V5 release notes reviewed against your master records. Regression scope agreed.
KPIs, roadmap, regulator or notified body updates (M&S entitlements for on-prem).
Most enterprise buyers run the self-serve 7-day trial first. Your evaluation team sees the auto-assembled IQ/OQ evidence, the device pairing flow and the Part 11 audit trail in a live sandbox — before procurement, before the SoW, before a single meeting.
Editable Word templates mirroring the five phases above — take them to your QA, procurement and legal teams before we ever get on a call.
Master programme doc: scope, RACI, phase gates, milestones, risks and change control. Customer completes the [bracketed] fields before kickoff.
Download .docxContract-flavoured template: deliverables, acceptance criteria, RACI, fees, assumptions and sign-off. Sits under the MSA (SaaS) and On-Prem Addendum (on-prem).
Download .docxTemplates are for evaluation. Executed versions are issued under the Master Subscription Agreement and, for on-prem deployments, the On-Premises Licence Addendum.
Tell us your site count, regions, current eQMS and target go-live. We'll come back with a phased plan, a named implementation lead and a fixed-scope quote.
