Enterprise implementation
One programme for every site.
Six gated phases, from discovery to steady state. Your QA team owns sign-off; V5 provides the evidence, installer, training and a named implementation lead.
Discovery & scoping
Foundation, Site 1
Pilot line validation
Train-the-trainer
Multi-site rollout
Steady state
What happens in each phase?
Six gated phases, evidence first
Each phase has exit criteria signed by Customer QA, and the next phase starts when the previous one closes.
Phase 1 of 6
Discovery & Scoping
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.
Gate evidence: SoW · site list · integration map · validation strategy
Who does what?
V5 provides the evidence. Your QA signs.
V5 delivers
- Signed installer, IQ pack, OQ template; PQ planned by your team
- Validation summary, SBOM, Part 11 / Annex 11 evidence
- Named implementation lead + escalation path
- Train-the-trainer curriculum, SCORM/xAPI exports
- Per-environment activation keys with expiry and grace
- Quarterly business reviews and change-board alignment
You own
- Named exec sponsor, PM, QA and IT lead per site
- URS authoring, risk assessment, PQ in your process context
- OQ countersignature and final validation approvals
- Site readiness pack (network, hardware, integrations)
- Data migration decisions, regulatory scope declarations
- Operator training delivery once trainers are certified
Self-install path: your IT executes the install
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.
How is the programme run?
Cadence over ceremony
Weekly
- Forum
- Implementation cell
- Purpose
- V5 lead + Customer PM + QA + IT. Working session, blockers, evidence review.
Fortnightly
- Forum
- Steering committee
- Purpose
- Exec sponsors, programme director. Phase gate decisions, risk log.
Monthly
- Forum
- Change board
- Purpose
- V5 release notes reviewed against your master records. Regression scope agreed.
Quarterly
- Forum
- Business review
- Purpose
- KPIs, roadmap, regulator or notified body updates (M&S entitlements for on-prem).
What will we sign?
See the templates first
Editable Word templates mirroring the phases above, to take to your QA, procurement and legal teams before a call.
Templates are for evaluation. Executed versions are issued under the V5 Commercial Terms for Software and Services, the SG Systems EULA and, for on-prem deployments, the On-Premises Licence Addendum.
Ready for a scoped programme?
Tell us your site count, regions, current eQMS and target go-live. Many teams run the 7-day trial first.