Audit Readiness & GxP Compliance Audits
- GxP and IT Expertise from a Single Source
- 30+ Years of Experience in Regulated Industries
- SAP Silver Partner
GxP Audit Readiness
Regulatory inspections, customer and supplier audits are an integral part of regulated industries such as Pharma, Biotechnology and Medical Technology. At the same time, IT systems, cloud solutions, data integrity and AI are increasingly coming into the focus of inspectors.
Many companies have established individual measures – but often lack a holistically managed audit readiness concept. Compliance is implemented operationally but not consistently anchored strategically.
For management and QA and IT leadership, this means a significant risk:
Audit findings can jeopardize approvals, delivery capability and reputation. At the same time, CSV and IT compliance are among the central inspection focus areas.
Additionally: Short-term audit preparation ties up significant resources, while remediation measures after findings are considerably more cost-intensive than preventive approaches.
Conclusion: Audit readiness is not an operational topic, but an enterprise-wide management task.
DHC supports you in managing your auditability in a structured, sustainable and forward-looking manner – instead of merely reacting to inspections.
Challenges in CSV & Data Integrity Audits
Unclear Documentation Status
CSV frameworks have grown historically, are inconsistent or not fully maintained.
Audit Trail Data Governance
Technical functions are available – but organizational implementation is not reliably documented
Infrastructure & Cloud Risks
Supplier qualification, shared responsibility models or IT infrastructure qualification are not sufficiently audit-proof.
Audit Readiness as Part of Your Compliance Governance
DHC does not view audits as one-time events, but as part of structured compliance governance.
We analyze your CSV framework, IT infrastructure, supplier management and data governance structures and evaluate them along regulatory requirements such as:
- FDA 21 CFR Part 11
- EU GMP Annex 11 & 15
- GAMP 5
- Data integrity guidelines (ALCOA+)
The goal is a clearly prioritized risk profile with actionable measures – transparent for management and documented in an audit-proof manner.
DHC Audit & Assessment Packages (Fixed-price Packages) AP (FAQs)
CSV Assessment
Is your CSV framework complete and robust?
At a fixed price, we offer you an assessment of your CSV framework regarding completeness, robustness and currency. After completion, you receive a summary of results with specific recommendations for action.
Readiness Pre-Audit
Are you inspection-ready?
At a fixed price, we offer you a pre-audit for a status assessment. We gain an overview of your CSV framework and conduct spot checks of system documentation. Afterwards, you receive a summary of results with specific recommendations for action.
IT Infrastructure Assessment
Is your IT infrastructure qualification on solid ground?
At a fixed price, we offer you a pre-audit for a status assessment. We gain an overview of your qualification framework for IT infrastructure and conduct spot checks of qualification documentation. After completion, you receive a summary of results with specific recommendations for action.
Cloud Compliance Assessment
How does the validation and compliance of your cloud solutions stand?
At a fixed price, we offer you an assessment of your supplier management and your CSV approach in cloud computing. We gain an overview of your supplier management SOP, supplier qualification and qualification and validation strategy for cloud solutions. Afterwards, you receive a summary of results with specific recommendations for action.
Data Integrity Assessment
Do you have data integrity under control?
At a fixed price, we offer you an assessment of your data governance system and a sample check at system level. Afterwards, you receive a summary of results with specific recommendations for action.
Advanced Audit & Inspection Services
In addition to fixed-price offerings, we accompany you comprehensively:
Audit Training & Mock Inspections
- Training on audit behavior and roles
- Simulated regulatory inspections
- Preparation of key personnel
Topic-specific Reviews
- 21 CFR Part 11
- Data Integrity
- Authorization concepts
- ERP, LIMS, eDMS, CDS reviews
- Periodic Reviews
Audit Support
- Support before, during and after inspections
- Accompaniment of regulatory and customer audits
- Conducting supplier & cloud service provider audits on your behalf
Why DHC – Your Specialist for Audit Readiness
For more than 30 years, we have been supporting companies in regulated industries in ensuring their auditability.
Our strength lies in the combination of CSV expertise, IT architecture understanding and practical inspection experience.
We know typical inspection patterns of FDA and European authorities as well as the most common compliance weaknesses in systems.
Audit Readiness
Trust through Experience
We are the specialist for all QM, QA and QC solutions based on SAP ERP.
“The Friendly Audit by DHC and the resulting report provided us with inspection-ready evidence for electronic records and signatures, audit trails and traceability – aligned with recognized regulatory expectations. This made sponsor discussions and vendor qualification reviews significantly easier and more efficient.”
Frequently Asked Questions about Audits (FAQs)
Are pre-audit and friendly audit the same thing?
No, the terms are often used synonymously, but differ slightly in their objectives:
A pre-audit serves the targeted preparation for an official audit or inspection. It closely follows the actual regulatory requirements and aims to identify and address weaknesses early.
A friendly audit (mock audit) on the other hand is usually less formal and more focused on coaching and learning. It simulates an audit situation in a supportive atmosphere to promote understanding and confidence in dealing with audits.
Conclusion: Both formats prepare for audits – the pre-audit is generally more rigorous and realistic, while the friendly audit focuses more on training and development.
When do a pre-audit or friendly audit make sense?
A pre-audit or friendly audit is particularly useful when you want to specifically prepare your organization for an upcoming audit or inspection or generally improve your auditability.
Typical use cases are:
Before regulatory inspections or customer audits, to identify weaknesses early
After the introduction of new systems or processes, e.g. in the context of digitalization or cloud transformation
When regulatory requirements change, e.g. in the area of data integrity or AI
For regular compliance reviews, as part of a continuous improvement process
For training and awareness of employees in dealing with audit situations
Conclusion: Pre and friendly audits help minimize risks, gain confidence in audit situations and make the organization sustainably audit-ready.
Audit Readiness