GAMP-aligned user access management

Govern every access decision across your GxP systems

Govern X brings requests, approvals, provisioning, periodic reviews, revocation and inspection evidence into one controlled lifecycle — built for pharmaceutical and life-science operations.

One governed recordRequest, approval, execution, review and revocation stay connected.
Native system rolesGovern the roles that exist in each target system without a second role layer.
Signed decisionsElectronic signatures and reason-for-change support accountable GxP actions.
Inspection evidenceSearchable audit history, access reports and exportable records are built in.
Where control breaks down

Identity and access challenges in GxP operations

Govern X addresses the everyday gaps created when requests, target-system work and review evidence live in separate places.

Disconnected approvals

Route each request through its configured approval path, while keeping the decision history attached to the request.

Provisioning uncertainty

Track automated jobs and evidenced manual tasks instead of losing the final execution step after approval.

Orphaned access

Surface identities that no longer align with the governed directory and take a recorded remediation action.

Training and SoD gaps

Present training status and segregation-of-duties conflicts in the request and risk context before access changes.

Incomplete evidence

Keep approvals, signatures, target-system work and lifecycle events available in a searchable audit record.

Review backlogs

Run periodic access certification, monitor completion and bring overdue reviews into Risk Radar.

One controlled lifecycle

From access need to verified outcome

The original request remains the traceable thread through approval, execution, periodic review and removal.

01

Request

Select a person, system, native role and business justification through a guided step-by-step wizard.

02

Assess

See approval routing, training context and segregation-of-duties findings before submission.

03

Approve

Capture accountable decisions and electronic signatures at each configured approval stage.

04

Execute

Follow automated provisioning or an evidenced manual procedure, tracked to completion.

05

Review

Certify, remediate, revoke and retain the complete history for inspection.

Purpose-built work areas

Each team sees the controls it needs

Permissions shape the available work, while server-side checks protect every governed action.

Requester

Scientists and operators

Submit requests, track progress, view assigned access and manage their own profile.

Approver

QA and application owners

Assess requests, review control context and execute accountable decisions.

Reviewer

Quality and audit

Run access certifications, inspect evidence, review risks and export reports without granting access.

Administrator

Platform operations

Register systems, configure workflows, manage integrations and maintain governance settings.

Built for regulated operations

Controls that work together, not as separate modules

Every capability contributes context or evidence to the same governed access lifecycle.

Approval workflows

Configure staged decision paths for access activities.

  • Sequential approval stages
  • Delegation and SLA visibility
  • Signed approve and reject decisions

Provisioning control

Manage automated execution and evidenced manual work.

  • Job queue with status and retry
  • Published manual procedures
  • Target-state reconciliation before fallback

HR-driven JML intake

Process joiner, mover and leaver events from registered HR sources.

  • Webhook or scheduled pull intake
  • Authoritative-source mapping
  • Leaver queue and account-disable flow

Risk Radar

Focus action on live access-governance findings.

  • Orphaned account findings
  • Training and SoD gaps
  • Overdue access reviews

Access Passport

Open a consolidated identity or system access dossier.

  • Entitlements and training verdicts
  • SoD conflict context
  • Lifecycle timeline and CSV export

Reports and evidence

Prepare operational and inspection-ready views.

  • Access by system and orphaned accounts
  • Training, SoD and review-completion reports
  • Full audit export and print-to-PDF
Govern the target, not a duplicate model

Work with the roles your systems already use

Register each governed system, define its access lifecycle and bring its native role or group model into requests, approvals and reviews.

  • System metadata, ownership, criticality and environment
  • Connection verification and role discovery where configured
  • Compliance rules, manual procedures and review schedule

Application systems

Register GxP and enterprise applications, then configure their access activities and target operations.

Directory / AD groups

Discover governed directory groups and track approved group membership changes.

Databases

Catalog database roles and govern approved grants or revocations through the configured execution path.

Periodic review campaign · illustrative
LIMS — Analyst roles0 of 42 decisions recorded
0%
eDMS — Reviewer roles0 of 26 decisions recorded
0%
ERP — Finance rolesScheduled for next cycle
Periodic certification

Review discovered access against a frozen population

Generate an access review from synchronized grants, record signed decisions and preserve campaign progress and completion evidence.

  • Search by account, system or role
  • Reviewer work queues and attestation decisions
  • Scheduled review register and campaign history
  • Completion reporting and overdue-risk visibility
Evidence by design

A defensible record of who did what, when and why

Govern X keeps a computer-generated, time-stamped trail of access, approval, signature and execution events. Records are append-only at the application level and linked through a SHA-256 hash chain, with integrity verification and export built in.

21 CFR Part 11 audit support
ALCOA+ evidence views
EU GMP Annex 11 matrix
ISO control mapping
Electronic signature manifest
CSV, audit package & print export
Audit trail

Move from event search to inspection package

Filter by actor, action, category, system, date, GxP relevance or signature status. Verify chain integrity and export the evidence required for review.

  • Actor, timestamp, action, reason and system context
  • User access history alongside platform events
  • Integrity verification for the hash-linked chain
Guided self-service

Request the exact activity the user needs

A step-by-step request flow supports access grants, role removal, account disablement and password-reset activities while preserving the business context.

  • Request for yourself or an eligible person
  • Select the registered system and its native roles
  • Save a draft and track status through completion
What changes

Before and after a governed access platform

The same activities, with a system of record behind every decision.

ActivityWithout a governed platformWith Govern X
Approval trailScattered across email and spreadsheetsRouted, signed and retained with the request
ProvisioningManual tickets with no confirmation loopAutomated jobs or an evidenced manual procedure, tracked to completion
Periodic reviewsAd hoc exports reconciled by handScheduled campaigns against a frozen population, with signed decisions
Audit readinessReconstructed after the factSearchable, hash-chain verified, exportable on demand
Role modelAccess lists duplicated outside the systemNative system roles governed directly, no second role layer

Walk through Govern X with your own access scenario

Explore how a request moves from business need to approval, target-system execution, review and inspection evidence.

Govern X Pharmaceutical user access governance for regulated operations.