Access Provisioning

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • User Access, Roles & Permissions Lifecycle • IT, QA, Security, Compliance

Access provisioning is the controlled lifecycle process for granting, changing, and removing user access to systems, data, and regulated workflows. It answers a simple question in a defensible way: Who can do what, where, and why? Provisioning is not just “creating an account.” In regulated manufacturing software, provisioning is a governance control that ensures access is appropriate to job function, aligned to user access management (UAM) and roles & permissions (often RBAC), and recorded with attribution and traceability via audit trails and data integrity expectations (including Part 11/Annex 11 principles where applicable).

Provisioning is a high-impact control because access is power. If access is granted informally, people inevitably end up with privileges they shouldn’t have: approving their own work, releasing quarantine lots, editing controlled records, overriding hard gates, or changing master data without change control. Those failures don’t always show up as obvious incidents. They show up later as weak investigations, inconsistent batch records, traceability gaps, and audit findings where the only honest answer is “we can’t prove who had access when the record was created or changed.”

“Provisioning is where security becomes a quality control. If access isn’t controlled, nothing else is truly controlled.”

1) What Access Provisioning Covers

Provisioning covers the full “access lifecycle,” not just onboarding. It includes new user creation, role assignment, permission changes, temporary access elevation, account suspension, and access removal. It also includes access to specific sites, departments, product lines, warehouses, and sensitive data sets—because “can view” and “can approve” are different risks than “can edit,” “can release,” or “can override.”

In regulated operations, provisioning must also cover access to actions that change compliance posture, such as: releasing holds, approving deviations, closing CAPAs, editing controlled master records, changing label templates, or modifying quality workflows. Those are not normal “IT permissions.” They are quality controls enforced by the system.

2) Provisioning vs Authentication vs Authorization

These terms are commonly mixed together, but each has a distinct function:

• Authentication: proving the user is who they claim to be (password, MFA, SSO, etc.).
• Authorization: what the user is allowed to do (roles, permissions, data scope).
• Provisioning: the process that creates and changes authorization over time (who gets which roles, who approved it, and when it changes).

Authentication can be strong and provisioning can still be weak. If you have MFA but grant admin rights via a Slack message, your system is not controlled. Provisioning is the governance layer that makes authorization auditable and defensible.

3) The Core Objectives: Least Privilege and Segregation of Duties

Provisioning exists to enforce two non-negotiable objectives in compliant environments:

• Least privilege: users get only the access they need to do their job—no more.
• Segregation of duties (SoD): prevent the same person from executing all critical steps of a controlled workflow (for example: create + approve + release).

These objectives are not theoretical. They directly affect whether electronic records are trustworthy. If a production user can edit an eBMR after execution, the record is weak. If a warehouse user can release a quarantined lot, hold logic becomes optional. If a system admin can approve quality decisions, the audit story becomes murky unless compensating controls are in place.

4) A Defensible Provisioning Workflow

A practical provisioning workflow is simple, repeatable, and evidence-based. A common structure looks like this:

• Step 1 — Request: requester identifies user, job function, site/scope, and required roles with justification.
• Step 2 — Identity verification: confirm user identity and unique account creation (no shared credentials).
• Step 3 — Approvals: manager approval for standard roles; QA/security approval for high-risk roles (release, audit trail review, admin, override).
• Step 4 — Provisioning execution: assign roles, scopes, and any required training prerequisites; enforce MFA/SSO policies.
• Step 5 — Evidence capture: log approvals, role assignments, timestamps, and provisioning agent identity in audit trail.
• Step 6 — Validation: confirm access matches request; confirm SoD conflicts are not introduced.

When this workflow is standardized, access changes become routine and defensible. When it’s improvised, access becomes “whatever was needed that day,” and that is how systems drift into uncontrolled states.

5) High-Risk Access Categories That Require Extra Controls

Not all access changes are equal. A mature provisioning program treats some categories as “high risk” and applies stricter approval and monitoring:

• Release authority: ability to release quarantine, approve hold/release, or disposition lots/batches.
• Approval & e-signature: ability to sign or approve regulated records (Part 11 context).
• Overrides: ability to bypass gates, accept exceptions, or force completion of controlled steps (see hard gating concepts).
• Master data/config changes: recipes, specs, limits, label templates, workflows—anything that changes “what the system enforces.”
• Admin roles: user management, role creation, audit trail configuration, integration keys and system settings.
• Data export: ability to export or bulk download sensitive data (customer, supplier, batch, quality events).

High-risk access should be tightly controlled and time-bounded where possible. Permanent “admin for convenience” is one of the fastest ways to create audit exposure.

6) Time-Bounded Privileges and “Break Glass” Access

Real operations sometimes need temporary elevation: troubleshooting, emergency production support, investigation support, or audit data pulls. The correct way to handle this is time-bounded, logged elevation with explicit approvals and automatic expiration. This is often called “break glass” access when used for urgent incidents.

A defensible temporary access model includes:

• Explicit justification: what problem requires elevation.
• Approvals: manager + QA/security approval for high-risk elevation.
• Short duration: hours/days, not weeks/months.
• Automatic expiry: privileges revert automatically.
• Enhanced monitoring: review audit trail events during elevation window.

Temporary elevation that becomes permanent is a control failure. Provisioning should be designed to prevent that drift.

7) Deprovisioning: The Most Important Step People Neglect

Deprovisioning is removing access promptly when it’s no longer justified. It is often the most important part of provisioning because stale access is a quiet risk multiplier. Common triggers for deprovisioning include termination, role change, contractor offboarding, long leave, or site transfer.

A strong deprovisioning process includes:

• Immediate disable on termination: access removed promptly to reduce security and integrity risk.
• Role change cleanup: old roles removed when new roles are assigned (avoid “role stacking”).
• Contractor expiry: contractor accounts expire automatically unless renewed.
• Periodic stale-account review: identify inactive accounts and remove or disable them.

Auditors routinely test this. They ask for a list of users and look for ex-employees with active access. If you can’t demonstrate clean deprovisioning, the integrity of the entire electronic system is questioned.

8) Periodic Access Reviews: Preventing “Role Creep”

Over time, users accumulate permissions. It happens naturally: “give them access to fix this,” “add this report,” “just for this one batch.” Role creep is predictable. Periodic access reviews exist to reverse it.

A practical access review program:

• Review cadence: quarterly/semiannual for standard roles; more frequent for high-risk roles.
• Review scope: who is in each high-risk role; whether role membership is justified; whether SoD conflicts exist.
• Evidence: review sign-off recorded, changes documented, and audit trail reflects removals.
• Exception handling: document why a conflict is accepted and what compensating controls exist.

Access reviews are not busywork. They are how you keep an RBAC model stable over years, especially as plants grow and staff change.

9) Provisioning and Audit Trails: Proving Access at the Time of the Event

When something goes wrong, the question isn’t “who has access today.” The question is “who had access when the record was created or changed.” That is why provisioning changes must be captured in audit trails with timestamps and attribution.

A defensible audit story can show:

• Role assignment history: when a user gained and lost a role.
• Approval history: who approved the role assignment and why.
• Event linkage: the user actions in regulated workflows during that access window.

This is where provisioning becomes a data integrity control. If you can’t reconstruct access history, you can’t fully defend actions, approvals, or outcomes.

10) Common Failure Modes (How Provisioning Breaks)

Provisioning programs usually fail in predictable ways:

• Shared accounts: destroys attribution and weakens audit trail defensibility.
• Ad hoc admin grants: “just make them admin” becomes permanent and unreviewed.
• No SoD checks: users end up able to create and approve the same records.
• Weak offboarding: ex-employees or contractors retain access.
• Role creep: accumulated privileges not periodically reviewed.
• Uncontrolled role changes: role definitions changed without governance, effectively changing system controls without awareness.

The fix is not more training alone. The fix is a controlled provisioning workflow with approvals, time-bounded elevation, and periodic reviews that keep the model stable.

11) How This Fits with V5 by SG Systems Global

Role-based control across modules. In the V5 platform, access provisioning ties directly to role-based permissions that govern WMS movements and holds, MES execution and sign-offs, and QMS approvals, deviations, MRB, and CAPA. Provisioning ensures users receive the right capabilities without expanding integrity risk.

Auditability. Provisioning events can be captured as attributable changes with a clear history of role assignments and approvals, supporting audit questions like “who could release holds” or “who could approve this deviation” at the time the event occurred.

Bottom line: V5 makes provisioning meaningful by linking it to enforced workflow controls. Access is not just a login—it becomes a documented, auditable control that protects batch records, quality decisions, and traceability evidence.

12) FAQ

Q1. What is the difference between provisioning and RBAC?
RBAC defines roles and permissions. Provisioning is the lifecycle process that assigns users to those roles, changes access over time, and removes access when no longer justified.

Q2. Who should approve high-risk access?
Typically a manager plus QA/security (or equivalent governance) for roles that can release holds, approve regulated records, override gates, or change master data/configuration.

Q3. How fast should deprovisioning happen?
Immediately upon termination, and promptly upon job change or contractor offboarding. Delayed deprovisioning is a known audit finding and a security risk.

Q4. Are shared accounts ever acceptable?
No. Shared accounts weaken attribution and audit trails. Unique user identity is essential for defensible electronic records and approvals.

Q5. How do we prevent “role creep”?
Use time-bounded elevated access, require approvals for high-risk roles, and perform periodic access reviews that remove stale or unjustified permissions.

Q6. What should be in an access review?
Who is in high-risk roles, whether role membership is justified, whether segregation-of-duties conflicts exist, and whether compensating controls are documented where conflicts are unavoidable.

Related Reading
• Access & Governance: User Access Management | Role Based Access | Approval Workflow | Change Control
• Integrity & Evidence: Data Integrity | Audit Trail (GxP) | 21 CFR Part 11 | Annex 11
• Execution Context: WMS | MES | V5 QMS