GxP IT Inspection Readiness

Always ready for regulatory Inspections and Customer Audits

GxP IT Inspection Readiness

Inspections by the FDA, government agencies, or Swissmedic, as well as customer audits, are an integral part of GxP-regulated industries. As GxP-critical business processes become increasingly digitized, IT systems, cloud solutions, data integrity, and AI are increasingly coming under the scrutiny of inspectors.
Inspections and audits cannot be fully planned. What can be planned, however, is your own preparedness and inspection readiness.
DHC supports pharmaceutical and medical technology companies in ensuring that their computer-based systems, processes, and documentation are consistently inspection-ready. This eliminates the need for frantic and time-consuming preparations right before the inspection date, instead creating a robust system that is effective in day-to-day operations for GxP IT compliance, data integrity, and traceable decisions.
Inspection readiness means: knowing the requirements, managing risks, keeping supporting documentation readily available, and being able to provide reliable information when it matters most.

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Challenges in Inspections and Audits

Data Integrity

Validation documentation is not complete, consistent, or up to date. Data flows, system interactions, and audit trails have not been adequately assessed and are not reviewed on a regular basis.

Cloud Risks

Critical systems and infrastructure components are provided and operated by cloud providers. Cloud solutions, providers, and outsourced IT services are not adequately tested and monitored.

Business Risk

For management, as well as QA and IT leadership, this poses a significant risk: inspection findings can jeopardize approvals, delivery capabilities, and reputation.

The Solution

Friendly Audit for Inspection Readiness Assessment and Inspection Readiness

An inspection should not be the moment when an organization first has to demonstrate its compliance. With a Friendly Audit for GxP IT Compliance, we simulate a regulatory inspection or customer audit under realistic conditions—constructively, independently, and without the formal consequences of an inspection. We analyze and evaluate your current level of inspection readiness and identify areas requiring action in the relevant areas of GxP IT compliance.

Our experienced auditors and IT QA/CSV specialists:

conduct interviews with management, QA, IT, and business units,
review their CSV framework, selected systems, processes, and validation documents,
ask typical inspection and audit questions,
evaluate the traceability of decisions and supporting documentation,
verify consistency between SOPs, actual practice, and system documentation,
examine the handling of discrepancies, data integrity, and audit trails,
identify critical, significant, and areas for improvement,
provide specific guidance on how to permanently address identified gaps.

The result is a formal Friendly Audit Report that documents and evaluates nonconformities and deficiencies and provides recommendations for action.

Our Services

DHC Friendly Audit Packages for your Inspection Readiness

Let’s work together to assess how well your organization is currently prepared for a government inspection or a customer audit. DHC will guide you through the process—from the initial readiness assessment and the friendly audit to the sustainable implementation of the necessary measures.

Friendly Audit Package S:
Assessment of CSV & GxP IT Compliance

A concise introduction:
DHC reviews selected IT QMS documents and processes, as well as the relevant validation documentation for a system (project and operations), and documents and evaluates deviations and deficiencies.

Result:
Summary documentation and evaluation of the reviewed CSV processes and validation documentation.

Friendly Audit Package M:
Friendly Audit CSV & GxP IT Compliance

This package covers all steps of a Friendly Audit. The scope and execution of the audit are coordinated and documented in the audit plan. During the audit, the IT QMS documents and processes, as well as the validation documentation for the selected systems (project and operations), are reviewed through document reviews and interviews. Any identified nonconformities and deficiencies are documented and evaluated in the audit report. The formal audit report also describes the scope and process of the Friendly Audit and includes a management summary. Appropriate recommendations for action are developed for all identified nonconformities and deficiencies and presented at a closing meeting.

Result:
An audit plan and a final, formal audit report that documents and evaluates the scope, process, and results of the Friendly Audit and presents corresponding recommendations for action.

Friendly Audit Package L:
Friendly Audit CSV & GxP IT Compliance + Inspection Readiness Process

This package includes all the steps and content of the Friendly Audit Package M.
Inspection readiness is not a one-time activity, nor is it a project that ends with the completion of an audit. Based on the findings and insights from the Friendly Audit, DHC develops a plan with measures for establishing a sustainable inspection readiness process.

Result:
Audit plan, audit report with recommendations for action, and a concept for a sustainable inspection readiness process.

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Why DHC – Your Specialist in Inspection Readiness

For more than 30 years, we have been helping companies in regulated industries ensure their inspection readiness.

Our strength lies in the combination of GxP IT compliance and CSV expertise, an understanding of IT systems, and practical inspection experience.

Through our hands-on support during regulatory inspections (FDA, government agencies, Swissmedic) and customer audits, we are familiar with typical inspection and audit patterns as well as the most common compliance weaknesses in system landscapes.

Customers

Trust through Experience

We are the specialist for Computer System Validation (CSV) of GxP-relevant Systems

“The GxP Cyber Security Check by DHC was part of our internal audit program. The audit provided a comprehensive assessment of our governance and technical control measures. This enabled us to identify critical gaps and prioritize their remediation. By strategically allocating our resources, we are strengthening our security posture and enhancing our defenses against evolving cyber threats. This proactive approach ensures that our systems remain robust and trustworthy while safeguarding our valuable digital assets.”

Dr. Athene Giessen

Associate Director IT-Compliance, Molecular Partners

“The friendly audit conducted by DHC and the resulting report provided us with inspection-ready evidence covering electronic records and signatures, audit trails, and traceability, aligned with recognized regulatory expectations. This made discussions with sponsors and vendor qualification assessments significantly easier and more efficient.”

Danckert Mellbye

Chief Operating Officer, Ledidi AS

Are your GxP IT processes truly inspection-ready?

Inspection readiness does not develop overnight and cannot be achieved just before an inspection. Let’s work together to assess how well your systems, processes, and documentation are currently positioned and identify the measures that will strengthen your audit readiness in the long term.

FAQs

Frequently asked Questions about Inspection Readiness

What does “inspection readiness” mean for management?

Inspection Readiness means that your company can provide reliable information about GxP-relevant systems, processes, data, and decisions at any time. Documentation must be available, traceable, and consistent. For management, this reduces the risk of critical findings that could jeopardize approvals, delivery capabilities, and reputation.

How can the current level of inspection readiness be objectively assessed?

A thorough assessment of the current state of affairs is conducted, for example, as part of a friendly audit. This involves reviewing, among other things, relevant IT QMS documents, selected systems, validation documentation, processes, and interviews with management, QA, IT, and business units. In addition, typical inspection questions, data integrity, audit trails, and the handling of nonconformities are evaluated.

Is inspection readiness still relevant even if there is no upcoming regulatory inspection?

Yes. Inspection readiness is not a one-time project that begins only when an inspection is announced. Systems, processes, and documentation are constantly changing. Maintaining a sustained state of readiness ensures that supporting documentation remains up to date and that the organization can provide reliable and consistent information even on short notice.

How do cloud and SaaS solutions affect inspection readiness?

For cloud and SaaS solutions, responsibilities between the company and the provider must be clearly defined. Of particular importance are the evaluation of the supplier, data flows, access rights, audit trails, changes and releases, and the availability of appropriate documentation. It is crucial that the outsourced infrastructure continues to be effectively monitored and integrated into the GxP and compliance framework.

How can validation be conducted in a cost-effective and compliance-compliant manner given frequent release cycles?

Not every change requires the same level of testing. A risk-based approach helps to specifically evaluate critical functions, data, and processes and to appropriately define the scope of validation. At the same time, changes, decisions, tests, and approvals must be documented in a traceable manner. This ensures that the system’s status remains under control without unnecessarily tying up resources.

How can you tell if a set of documents is audit-ready?

Audit-ready documentation is complete, up-to-date, consistent, and traceable. It must align with the processes as implemented and the actual system behavior. Consistency between SOPs, validation documentation, operational processes, deviations, and system documentation is particularly important. Decisions and the rationale behind them must also be traceable.

How important are data integrity and audit trails for inspections?

Inspektoren prüfen zunehmend, ob Daten vollständig, korrekt, konsistent und über ihren gesamten Lebenszyklus nachvollziehbar sind. Dazu gehört auch die Frage, ob Audit-Trails angemessen konfiguriert, regelmäßig ausgewertet und bei Auffälligkeiten bewertet werden. Schwachstellen in Datenflüssen, Berechtigungen oder der Audit-Trail-Kontrolle können zu kritischen Beobachtungen führen.

How should AI systems be taken into account in the context of inspection readiness?

AI systems should be evaluated based on their area of application, their GxP relevance, and their impact on quality- or patient-related decisions. Factors to be considered include, among others, data quality, traceability, roles and responsibilities, changes to the model, and human oversight. The goal is to ensure that AI applications are used in a controlled, traceable, and auditable manner.

What specific benefits does a Friendly Audit offer?

A Friendly Audit simulates a regulatory inspection or a customer audit under realistic yet constructive conditions. Companies receive an independent assessment of their current level of readiness, a structured evaluation of nonconformities and deficiencies, and specific recommendations for action. Depending on the scope, this can also lead to the development of a plan for a permanently established inspection readiness process.