ServiceNow Policy and Compliance Management for Life Sciences and Pharma

Policy management for life sciences and pharma turns GLP, GMP and GCP obligations into documents staff can attest to. Each policy needs the right version shown, exceptions are time limited and reviewed, and every policy is tied to the control that tests it. The page works through laboratory, manufacturing, clinical trial and data integrity policy sets.

Policy management for a life sciences or pharma company has to turn GLP, GMP and GCP obligations into documents staff can attest to, with the right version proven, exceptions time limited and reviewed, and each policy linked to the control that tests it. The sections below work through the laboratory, manufacturing, clinical trial and data integrity policy sets, then the practical questions: sorting documents into policies, procedures and work instructions, designing attestation, handling exceptions, and when policy management should not own the content.

Good Laboratory Practice and Research Integrity

Good Laboratory Practice (GLP) standards define requirements for laboratories conducting non-clinical safety testing of pharmaceutical products. GLP policies define laboratory organisation, personnel qualifications, standard operating procedures, record-keeping, and data integrity. Policy Management ensures GLP policies are documented and all laboratory personnel understand GLP requirements. New laboratory staff complete GLP training before working on GLP studies. This demonstrates regulatory compliance and ensures accurate research data.

Research data integrity is fundamental to GLP compliance. Data must be recorded accurately, reviewed for completeness, and protected from alteration. Policies prohibit data falsification, selective reporting, or concealment of study results. Policies should define electronic records requirements (electronic signatures, audit trails, data security) if electronic records are used. Lab personnel should understand data integrity requirements and consequences of data integrity violations.

Laboratory animal care and use policies comply with Institutional Animal Care and Use Committee (IACUC) standards. Policies define animal housing standards, veterinary care, pain and distress minimisation, and humane endpoints. IACUC review and approval is required before animal studies begin. Policy Management ensures laboratory personnel understand animal welfare requirements and procedures for ensuring animal welfare compliance.

Good Manufacturing Practice and Quality Standards

Good Manufacturing Practice (GMP) standards define requirements for pharmaceutical manufacturing ensuring product quality and safety. GMP policies define manufacturing facility requirements, equipment maintenance and validation, raw material controls, manufacturing procedures, quality control testing, and product release procedures. Policy Management ensures manufacturing staff understand GMP requirements and follow procedures. Manufacturing personnel receive GMP training on hiring and annually thereafter. This demonstrates commitment to quality and regulatory compliance.

Equipment validation policies ensure manufacturing equipment operates according to specifications and produces consistent results. Policies should define validation requirements for new equipment, equipment maintenance, and revalidation procedures when equipment is modified. Validated equipment must be used for manufacturing; unvalidated equipment use creates regulatory compliance risks and product quality risks. Policy Management can track equipment validation status and prevent use of unvalidated equipment.

Change control policies define procedures for implementing changes to manufacturing processes, facilities, or equipment. All changes must be evaluated for potential impact on product quality. Significant changes require validation and regulatory notification or approval. Policy Management should document change evaluations showing that regulatory impact was assessed and appropriate controls were implemented. This demonstrates that manufacturing changes followed regulatory procedures.

Clinical Trial Governance and Patient Safety

Good Clinical Practice (GCP) standards define requirements for ethical and scientific conduct of clinical trials. GCP policies define investigator qualifications, Institutional Review Board (IRB) oversight, informed consent procedures, protocol compliance, and patient safety monitoring. All clinical trial staff receive GCP training on hiring and annually thereafter. This ensures staff understand requirements for protecting research participant rights and safety.

Informed consent policies define procedures ensuring research participants understand trial participation and voluntarily agree. Consent forms must clearly explain study purpose, procedures, risks, benefits, and participant rights. Participants must be allowed adequate time for questions before agreeing. Policies should define procedures for obtaining renewed consent if protocols change. Documentation of informed consent provides evidence that participant rights were respected.

Adverse event monitoring policies define procedures for identifying, reporting, and investigating safety concerns during clinical trials. Serious adverse events must be reported to IRB and regulatory agencies within regulatory timeframes. Policies should define what constitutes serious adverse events, reporting procedures, and escalation authority. Close monitoring of safety data allows early identification of safety concerns allowing protective actions before widespread harm occurs.

Data Integrity and Record Management

Data integrity policies define procedures ensuring all laboratory and clinical data are accurate, complete, and unaltered. Electronic records must include audit trails showing who entered data, when, and what changes were made. Data cannot be deleted; corrections must be documented showing original data, reason for correction, and authorisation for correction. Policies should define procedures for data backup and disaster recovery ensuring data cannot be lost.

Record retention policies define how long data must be retained. Regulatory requirements typically mandate retention for specified periods (often years after product approval or termination of studies). Policies should define retention periods for different record types and procedures for secure data destruction after retention periods expire. Premature destruction creates compliance problems; retention beyond required periods wastes storage resources.

Records management systems must be secure and resistant to unauthorised access or alteration. Policies should define access controls (who can access what records), encryption requirements, and audit trail requirements for all access. Backup procedures should ensure records survive equipment failures or disasters. Policies should address regulatory requirements for electronic records security and validation.

Implementation Checklist for Life Sciences Compliance

• GLP policies define research standards; laboratory personnel receive GLP training before conducting GLP studies
• Data integrity policies define accurate recording, data review, and protection against alteration; electronic audit trails required for electronic records
• Animal care and use policies comply with IACUC standards; IACUC review required before animal studies begin
• GMP policies define manufacturing procedures; manufacturing staff receive GMP training and understand equipment validation requirements
• Change control procedures evaluate regulatory impact of manufacturing changes; significant changes require validation and regulatory action
• GCP policies define clinical trial requirements; all clinical trial staff receive GCP training
• Informed consent procedures ensure participants understand and voluntarily agree to participation; consent documentation maintained
• Adverse event monitoring procedures ensure serious events are reported within regulatory timeframes; safety data reviewed regularly
• Data retention policies document regulatory requirements; records securely retained for required periods and destroyed after expiration

Common Life Sciences Compliance Pitfalls

Life sciences organisations sometimes use informal procedures for critical processes that should be formalised to demonstrate regulatory compliance. GLP research without documented SOPs, manufacturing without documented change control, clinical trials without documented informed consent procedures—all these create regulatory compliance risks. Organisations should formalise all critical procedures and document compliance through Policy Management.

Training completion tracking sometimes fails allowing personnel to work without required training. GLP research should not proceed without GLP training documentation. Clinical trials should not proceed without GCP training. Policy Management should track training completion and prevent staff from working on regulated activities without documented training.

Regulatory inspection findings sometimes result from policies that are documented but not understood or followed. Staff may not actually know that new procedures were required. Effective compliance requires not just policies but training, verification of understanding, and monitoring of compliance with procedures. Policy Management should be integrated with learning management to ensure training is completed and understanding is verified.

Building a Compliance Culture

Life sciences compliance depends on leadership commitment to quality and integrity, clear policies and procedures, training that ensures understanding, and monitoring that verifies compliance. Organisations that build strong compliance cultures prevent regulatory violations and maintain the trust of regulators and research participants.

Sort your documents into policies, procedures and work instructions first

A policy owner in a laboratory or plant often finds that the policy library has grown into a single pile where a high-level commitment, a step-by-step procedure and a bench-side instruction all carry the same status. That makes review hard, because a change to one level ripples into the others, and it makes attestation meaningless, because staff are asked to sign for a document they cannot act on. Separate the three levels before any attestation is designed. The policy layer itself is the subject of policy and compliance management, so the steps below assume that layer is already in place. A policy states what the organization commits to and who is accountable. A procedure states the steps and the roles that carry them out. A work instruction states the exact actions at one station or on one instrument.

Each level should have its own owner, review trigger and approval route. A policy is reviewed when the regulatory expectation changes or when the organization changes its commitment. A work instruction is reviewed whenever the equipment or method it describes changes, which may be far more often.

Designing attestation so it proves understanding of the right version

Attestation is only evidence when the person signs the version that was in force for their role, and when the sign-off is tied to the training that made the instruction usable. Design the attestation so that it names the exact revision, lists the roles it applies to, and links to the training record for that revision. A signature on a superseded version should not count toward a current obligation, and the policy system should show that gap rather than hide it. Where training is the obligation behind an attestation, the training record for regulated roles should be linked directly to the signature.

Avoid bulk attestation campaigns that ask everyone to sign everything at once. They produce high completion figures with little meaning, and a reviewer who reads the record will see identical timestamps across unrelated documents. Attest at the point the person takes on the role or the document changes, which keeps each signature tied to a real event.

Exceptions that are granted, time limited and reviewed

Every regulated site will need a route for a documented exception, such as a temporary deviation from a procedure while a piece of equipment is repaired. The danger is an exception that quietly becomes the working practice. Require each exception to name the policy clause it departs from, the reason, the compensating control and the approver. Give it an end date that the system enforces, and route the exception to review before that date rather than after it has lapsed.

1. Record the clause affected and the reason in a single request, so the exception cannot be discussed without a written basis.
2. Name the compensating control and the person responsible for checking it while the exception is active.
3. Approve through the quality function where a regulated step is affected, and record the approver.
4. Set an end date, and send a reminder to the approver before it passes.
5. When the exception expires, either close it because the normal practice has resumed or raise a change to the policy or procedure so the exception is no longer needed.

Linking policies to the controls that test them

A policy that is never tested is a statement of intent, not a control. Where a policy clause depends on a specific control, record the link so that a failed control test shows up against the policy it protects. This link is what allows a governance review to see that a clause has no working control behind it, rather than discovering the gap during an inspection. Keep the policy clause and the control definition separate, so that a rewording of the policy does not silently change what the control is supposed to test. Controls and their owners are a question for governance, risk and compliance, and the link should be designed there.

When policy management should not own the content

Some content is better governed in the quality document system or in the engineering record. Equipment specifications, validated method parameters and batch manufacturing records have their own change control and retention rules. The policy platform should point to them and attest to the instruction that uses them, rather than becoming a second copy of the technical content. Keeping two copies of a method can lead to using the wrong one. Bench-level instructions held in a library need the same discipline, which should be handled through the controlled library described in knowledge management for this sector.

Frequently asked questions about policies in regulated sites

Should a contractor attest to the same policies as an employee?

Yes, for the policies and work instructions that apply to the work they perform. Assign attestation by role and by site access rather than by employment type, so that a contractor who performs a regulated step cannot skip the instruction because they are not on the employee list.

What happens to attestation when a policy is retired?

Retirement should not delete the attestations. Keep them against the retired version so the record shows what each person agreed to at the time, and remove the retired version from current assignments so that new staff are not asked to sign it.

How do we decide whether a change needs re-attestation or only notification?

If the change alters what a person must do, require re-attestation. If it corrects wording without changing an action, a notification with a read acknowledgment may be enough. The quality function should make and record this decision for every regulated document.

Can an exception be approved by the process owner alone?

Not where a regulated step is affected. The process owner can propose the exception, but the quality function should approve it, because the risk of the exception is a quality risk rather than an operational convenience.

Reviewing the policy structure

Separating commitments, procedures and bench instructions is often the first real improvement a policy library needs.