Learn how Clarix roles control access to modules, actions, and approvals across your 503B facility.

Roles and Permissions

Clarix uses role-based access control (RBAC) to ensure that every action in the system is performed by a qualified person. Your role determines which modules you can access, which actions you can take, and which approval workflows require your signature.

Roles and user management

How roles work

Each user account is assigned one or more roles by an Admin. Roles are scoped to your organization, so users at multi-site companies can have different roles at each facility. You will only see the modules and actions permitted by your assigned role — others are hidden or locked.

The 15 Clarix roles

Pharmacist-in-Charge (PIC)

The PIC is the final regulatory authority for your 503B facility. This is typically the licensed pharmacist named on your FDA registration.

What a PIC can do:

Approve and publish Master Formulas
Release batches (final sign-off after QA approval)
Override out-of-sequence step execution with their PIN
Manage staff qualifications and training plans
Configure system-wide settings
View all modules and reports

Role required: Only a PIC can perform the final batch release. This action requires a facility PIN and is recorded as an electronic signature under 21 CFR Part 11.

Compounding Technician

The primary shop-floor operator. Technicians execute batches, receive materials, and perform day-to-day production tasks.

What a Technician can do:

Start and execute batch steps
Scan barcodes during steps
Issue raw material lots to a batch
Enter measurements, data, and checklist responses
Receive incoming inventory lots
View their assigned batches and training plans

Role required: Technicians cannot approve formulas, release batches, or review deviations.

QA Officer

QA Officers are responsible for reviewing completed batches and approving them before the PIC release step.

What a QA Officer can do:

Review completed batch records (all steps, values, signatures)
Approve or reject batches for PIC release
Open and manage deviations and CAPAs
Review batch amendments
Access quality reports and audit trail
Release inventory lots from quarantine

QA Manager

The QA Manager has all QA Officer capabilities plus elevated access for oversight and escalation.

What a QA Manager can do:

Everything a QA Officer can do
Configure quality rules and thresholds
Manage CAPA workflows and sign off on closures
Approve deviations that require manager-level sign-off
Access cross-batch trend reports

QA Executive Committee

High-level quality oversight role for senior stakeholders and compliance officers.

What the QA Executive Committee can do:

Read-only access to all quality records, deviations, and CAPAs
Review 483-readiness reports and quality metrics dashboards
Cannot modify records — review and attestation only

Lab Technician

Manages QC lab samples and environmental monitoring activities.

What a Lab Technician can do:

Create and manage QC lab samples
Log environmental monitoring (EM) samples and results
Record endotoxin, bioburden, and sterility test results
View lab-related reports

Training Manager

Responsible for creating and managing personnel training programs.

What a Training Manager can do:

Create training plans and assign SOPs
Track staff training completion and qualification status
Mark training as complete or expired
Generate training compliance reports
Set up recurring training schedules

Document Controller

Manages the controlled documents library (SOPs, policies, forms).

What a Document Controller can do:

Upload, version, and retire controlled documents
Assign documents to training plans
Set document review cycles and expiry
Track acknowledgement status by staff member

Equipment Technician

Maintains equipment records, calibration schedules, and preventive maintenance.

What an Equipment Technician can do:

Add and manage equipment in the asset registry
Log calibration events and results
Record preventive maintenance (PM) activities
Upload calibration certificates
Set calibration and PM schedules with alerts

Admin

System administrators configure the platform and manage users. The Admin role does not grant production access by default.

What an Admin can do:

Create and manage user accounts
Assign and modify roles
Configure numbering sequences (batch, formula, lot numbers)
Set system-wide policies (inventory, formula, rules engine)
Manage organization settings and multi-site configurations
Access all settings panels

Note: Admins can configure the system but cannot approve formulas or release batches unless they also hold the PIC role.

Environmental Monitor

Performs environmental monitoring rounds in ISO cleanrooms.

What an Environmental Monitor can do:

Log EM samples (settle plates, air samples, surface samples)
Record readings against room monitoring plans
View environmental trending reports
Escalate excursions to QA

Viewer / Read Only

A read-only role for stakeholders, auditors, or observers who need visibility without the ability to change anything.

What a Viewer can do:

View all batch records, formulas, inventory, and reports
Download PDFs and exports
Cannot create, edit, or approve any records

Managing users

Role required: Only an Admin can create users and assign roles.

Go to Admin → Users in the sidebar.
Click Invite user and enter the staff member's email address.
Select their role(s) from the dropdown. A single user can hold multiple roles (e.g., PIC + Admin).
Click Send invitation. The user receives an email with a sign-in link.
Once they sign in, their role takes effect immediately.

To change a user's role, click their name in the users list and edit the Roles field. Changes apply to the next session.

Multi-site role assignment

If your organization has multiple facilities, users can have different roles at each site. When a user signs in and switches organizations using the Organization Switcher at the top of the sidebar, their permissions automatically update to match that facility's role assignment.

Dashboard — What you see after signing in
Navigation — How to move around Clarix
Batch QA & PIC Release — The approval workflow that relies on roles

Roles and Permissions

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