PlatformImplementation and go-live
eQMS implementation, from setup to go-live
In your real tenant. QMSdesk™ guides your team along a staged runway, lets you test real workflows in your real configuration, and keeps every test record as evidence. We plan eQMS implementation at 8–12 weeks to a first working workflow, depending on scope, data readiness and your team's availability.
Go-live readiness
Implementation Mode, in your real tenant
Workflow
Step 6 of 6: Go-Live
- Readiness checks
- Drawn from real test records
- Technical attestation
- Signed by the Administrator
- Quality attestation
- Awaiting the Quality Manager
What changes for you
01
Test what you'll actually run
The tenant you test in is the tenant you go live in. Your people try their own workflows, in their own roles, against your own configuration.
02
Keep the evidence
Records created while you test are never purged. They stay in the audit trail as proof your workflows were exercised before go-live, and they stay out of your live KPIs.
03
Go live on proof, not a checkbox
Go-live checks are drawn from real data, and two people sign: one for technical readiness, one for quality readiness.
The Configuration Runway: eQMS implementation in six stages
Six stages take you from an empty tenant to go-live:
Step 1 of 6
Foundation
Your organization's core settings.
Step 2 of 6
Access Control
Invite your people and give them their roles.
Step 3 of 6
Modules
Switch on what you'll run in QMSdesk.
Step 4 of 6
Workflows
Get the workflows your profiles bring ready to run.
Step 5 of 6
Implementation
Open the testing period and run real records end to end.
Step 6 of 6
Go-Live
Pass the readiness gate and sign.
Through the first four stages, operational modules stay locked, so no record is ever created against a half-built system. Navigation stays visible, with a note on when each module unlocks. A banner on every page, for every role, shows where you are and, once testing starts, how many go-live checks are complete.
Highlights
A go-live gate with two signed attestations
Go-live readiness checks are evidence-based: for example, the audit trail must show a real workflow step exercised for each event type you've switched on. Then two separately signed attestations are required, technical readiness from an Administrator and quality readiness from a Quality Manager. One person holding both roles still signs twice.
Evidence checks
Attestations
One person holding both roles still signs twice.
Implementation Mode, in your real tenant
When setup is done, an administrator opens the testing period. Every module works: draft and approve documents, drive CAPAs through their full workflow, test each person in their assigned role. A Command Center filter keeps these implementation-era records out of live operational metrics by default, and a PDF report that includes them carries a watermark saying so.
Paper to eQMS, with honest migration
Your eQMS document migration runs in batches. Each batch is imported under one signed migration attestation, and every migrated document carries a permanent "Migrated" badge. QMSdesk never invents in-platform approvals that didn't happen.
Change control after go-live
Every setting knows its own tier. A setting that affects your validated state can't be written until an approved change control reaches implementation, and the revalidation flag clears only by a signed decision. Lower-tier settings need a signature and reason, or are recorded in the audit trail. A newly required field applies to new records only.
A workflow engine that stays true
Every workflow is one versioned definition, read alike by the interface, the API and the validator. Administrators can't edit steps or reroute transitions, direct status writes are rejected, and a daily check flags any live workflow that has fallen behind its current definition.
Numbering that never repeats
Configure numbers per module from prefix, year, site, department and counter tokens. Prefixes are unique, numbers are never reissued or renumbered, and changes after go-live are signed.
Feature index
Everything in implementation and go-live
Configuration Runway and Implementation Mode
- Six stages: Foundation, Access Control, Modules, Workflows, Implementation, Go-Live
- Operational modules locked until setup passes its gates
- Persistent banner for every role until go-live, linked to the runway
- Testing in the same tenant, data and URL you go live on
- Implementation-era records kept, filtered from live KPIs by default
- Watermark on PDF reports that include implementation-era records
Go-live
- Evidence-based readiness checks, including a workflow step exercised per enabled event type
- Technical readiness attestation (Administrator), signed
- Quality readiness attestation (Quality Manager), signed separately
Migration
- Bulk upload through an import wizard
- One signed migration attestation per batch
- Permanent "Migrated" badge, with no fabricated approvals
After go-live
- Settings tiered by their own metadata
- Validation-affecting settings gated by approved change control
- Revalidation cleared only by a signed decision
- New required fields apply to new records only
- Regulatory profiles added under e-signature and change control
Workflow engine and numbering
- One versioned definition per workflow
- Locked steps and transitions; direct status writes rejected
- Daily workflow version check; reconciliation never overwrites customized rows
- Configurable numbering, never reissued
Alongside you: Akatalyst practitioners
QMSdesk™ is an Akatalyst platform. Walk the runway yourself with our support, or have Akatalyst deliver the rollout end to end: data migration, validation support, SSO, UAT and hypercare, scoped in writing. QMSdesk's core platform is validated, and we'll walk you through the full record under a mutual NDA. Your system is validated by you, for your intended use, and we set out your share of that work in a written validation scope.
One connected system
Connected across QMSdesk
Regulatory profiles: choose them when you set up your tenant, and add more after go-live.
Document control: migrated and reference documents are always labeled for what they are.
Change control: post-go-live configuration changes run as ordinary change controls.
Audit trail and e-signatures: the go-live attestations use the same signature as every approval.
Regulations
Regulations it's designed to support
Implementation Mode, the go-live gate and post-go-live change control are designed to support the validation and change-control expectations of 21 CFR Part 11, EU GMP Annex 11 and FDA's Computer Software Assurance guidance.
Questions buyers ask
How long does eQMS implementation take?
We plan for 8–12 weeks to a first working workflow, depending on scope, data readiness and your team's availability. The first workflow is scoped in writing before you start.
Where do we test before go-live?
In your real tenant, in Implementation Mode. Every module works, your people test in their own roles, and their records are kept as evidence.
Can we migrate our existing SOPs and documents?
Yes. Documents come in by batch under a signed migration attestation and carry a permanent "Migrated" badge. Their history stays honest: QMSdesk never creates approvals that didn't happen in the platform.
What happens when we need to change a setting after go-live?
It depends on the setting's tier. Settings that affect your validated state go through approved change control first; others need a signature and reason, or are simply audit-logged.