ServiceNow Governance, Risk and Compliance for Life Sciences and Pharma

Governance, risk and compliance (GRC) in life sciences is the set of controls that shows a pharma site meets its GMP, GLP and GCP obligations. This page helps a quality or compliance lead decide which system holds each kind of evidence, how to build a control library an inspector can follow and when a rollout should be paused.

GRC work in a life sciences or pharma company sits between the quality system and the regulator: GMP, GLP and GCP obligations have to be expressed as controls an inspector can follow, tested on an agreed cadence, and backed by evidence that holds up when someone asks for it. The sections below cover where the GRC record ends and the quality system record begins, how to build the control library, what a failed test should trigger, and when a rollout should be paused or narrowed.

Quality and Data Integrity Controls

Pharmaceutical operations require reliable quality and data integrity controls. Quality controls ensure that manufactured products meet specifications for purity, potency, and safety. Data integrity controls ensure that records are accurate, complete, and protected from unauthorised modification. These controls are fundamental to regulatory compliance and to ensuring that patients receive safe, effective medications. GRC systems document which controls have been implemented, track control effectiveness through audits and testing, and manage deviations when controls are found to be ineffective. Remediation of control failures is tracked until the control is restored to effectiveness.

Audit and Inspection Management

Pharmaceutical facilities are regularly audited and inspected by regulators and internal auditors. Audits assess compliance with regulations, effectiveness of quality systems, and adequacy of controls. GRC systems manage audit schedules, document audit findings, track remediation of findings, and maintain evidence of compliance. When regulators conduct inspections, organisations must be able to demonstrate compliance quickly; GRC systems provide this capability by centralising compliance documentation and evidence. Regular internal audits help organisations identify issues before regulators do, providing opportunity to remediate problems before they become regulatory violations.

Risk Management in Pharmaceutical Operations

Pharmaceutical organisations must manage multiple risks: product safety risks (if products are contaminated or ineffective, they harm patients), regulatory risks (non-compliance results in penalties and facility shutdowns), supply chain risks (suppliers may not meet quality standards), and cybersecurity risks (data breaches can compromise product integrity or expose clinical trial data). GRC systems help organisations assess these risks, implement controls to mitigate them, and monitor control effectiveness. Risk assessments help prioritise investments in controls where risks are highest.

Compliance Documentation and Audit Readiness

Pharmaceutical organisations must maintain extensive documentation demonstrating compliance: validation studies for manufacturing processes, training records for personnel, audit reports, deviation investigations, and corrective action evidence. This documentation must be preserved for years, sometimes decades. GRC systems maintain compliance documentation in a centralised, secure location where it can be easily retrieved for regulatory inquiries or audits. Audit readiness is continuous: compliance systems track whether compliance requirements are being met and identify gaps requiring attention.

Supply Chain Quality and Oversight

Pharmaceutical organisations depend on suppliers of ingredients, components, and contract manufacturing services. GRC systems track supplier compliance with quality standards and regulatory requirements. Suppliers are audited to verify their compliance capabilities. If suppliers fail to meet requirements, organisations must implement corrective actions or find alternative suppliers. Supplier risk management is critical to ensuring that organisations maintain control over product quality and regulatory compliance throughout their supply chain and manufacturing relationships.

Drawing the line between the GRC record and the quality system record

The question a quality or compliance lead usually faces first is not which controls to load. It is which system owns each kind of evidence. A pharmaceutical site normally already has a quality management system holding deviations, corrective and preventive actions, and document control. A GRC platform is useful for seeing the whole control picture across GxP, data privacy, supplier oversight and information security in one place. When both systems hold the same deviation, two records drift apart quickly and the auditor asks which one is true.

Settle ownership before any control is entered. For each category of evidence, name the system of record and state in one sentence why it lives there. The GRC platform should hold the control definition, the owner, the test schedule, the test result and the link to the issue it raised. The quality system should keep the investigation itself, the root cause analysis and the approved corrective action. Linking the two with references is far safer than copying text between them.

Building a control library that an inspector can follow

Control libraries often fail in one of two ways. Some copy the regulation sentence by sentence, producing hundreds of controls that nobody can test in a realistic way. Others are so summarized that a control reads as a slogan, with no defined owner, frequency or evidence. A usable library sits between these extremes. Each control states what must be true, who makes it true, how often it is checked and what a passing check looks like.

A sequence that works for most regulated sites runs as follows:

1. Start from the processes that carry the most product or patient risk, not from the full regulatory text. Manufacturing release, clinical data handling and supplier approval are often the first candidates.
2. Write each control as an observable state, for example that every critical reagent lot is linked to an approved supplier record before use, Write each control as an observable state, for example that every critical reagent lot is linked to an approved supplier record before use, rather than that the company manages supplier risk..
3. Assign one accountable owner per control. A shared owner means no owner, and the first audit question will expose it.
4. Agree the testing method with the quality function: a sample, a system query, a walkthrough or a review of exception reports. Record the method on the control so the tester does not invent one.
5. Map each control to the regulatory obligations it supports. Where one control serves GxP and privacy requirements together, record both, so that a single test answers both sets of questions.

Do not attempt to build the full library in one pass. The planning view of the evidence each policy needs is covered in the article on planning GRC policy evidence. A library of a few dozen well-tested controls is worth more during an inspection than several hundred controls where half have no evidence attached.

Testing cadence and what a failed test should trigger

A control test is only useful if a failure produces a visible action. Set the test frequency by the risk that the control addresses and by how quickly a failure could reach product or patient safety. High-risk controls on release decisions warrant tighter testing than low-risk controls on office equipment. Write the cadence into the control record rather than leaving it to the tester’s memory..

When a test fails, the GRC platform should open an issue and link it to the control. The issue should not close until the quality system has an approved investigation for any product-impacting failure, and until the control has passed a retest. A common gap is closing the GRC issue when the tester is satisfied, while the underlying deviation is open in the quality system. Build the closure rule so that both conditions must be met. Where findings from internal audits feed the same issues, the audit management approach explains how they are tracked and closed.

• A failed test on a product-impacting control links to a quality event before the GRC issue can progress.
• A retest is scheduled by the control owner, not by the person who raised the issue.
• Repeated failures on the same control trigger a review of whether the control design is adequate, not only whether the people following it are.

Evidence rules that hold up when someone asks for them

Evidence attached to a control should be specific enough that a second person can reproduce the test. A file named as a report is not evidence. A query result with the date, the filter used, the person who ran it and the population it covered is evidence. Decide early what counts as acceptable evidence for each control type, because retrofitting the rule after the audit has started is hard to defend.

Keep screenshots and exports under the same retention and access rules as the source data they came from. Supplier evidence follows the same discipline, and the vendor risk management page for this sector covers how vendors are rated by criticality. A GRC attachment that is copied out of a validated system can end up holding personal information or confidential process details in a place that was never validated for them. Record the source system and the extraction date with every export.

When a GRC rollout should be paused or narrowed

A GRC platform does not fix an unclear quality system. If the site cannot yet say which deviations are open, which suppliers are approved, or which procedures are current, the first phase should be data clean-up in the source systems, not a larger control library. Narrowing scope is often the right call: take one regulated process from start to finish, prove that the controls, tests, issues and evidence link together, and only then extend the pattern.

Also pause if the business owner for a control cannot explain what the control protects. An unexplained control becomes a tick-box, and tick-boxes can look like a weak quality culture to regulators.

Frequently asked questions about GRC in pharma

Should every regulated procedure be mapped to a control?

No. Map the procedures that protect product quality, patient safety or data integrity, and leave routine administrative procedures out of the control library. A library that includes everything becomes hard to test completely, and the important controls are buried among the trivial ones.

How do we handle a control that applies at one site but not another?

Model the control once with a clear scope that names the sites and processes it covers, and record the local variation as a documented exception with its own owner. Duplicating a control for each site makes the test results hard to compare and multiplies the maintenance effort.

Approving edits to a control definition

The owner of the control drafts the change, the quality function approves it, and the previous wording stays on record. Changes to controls that protect product quality should go through the same review as a procedure revision, because a loosened control definition can hide a real gap.

Can an outside auditor work directly in the GRC platform?

Access for external parties should be limited to the evidence and records they are entitled to see, granted for a defined window and reviewed afterwards. Give them read access to the controls and evidence they need, and avoid giving them access to unrelated risk or supplier records.

Scoping the first control set

A first control set works best when it covers one process from start to finish and every control has its test written before any evidence is attached.