Regulatory Risk & GxP Compliance
- GxP and IT Expertise from a Single Source
- 30+ Years of Experience in Regulated Industries
- SAP Silver Partner
GxP Compliance & Computer System Validation
GxP compliance is today a strategic success factor for companies in regulated industries. Digital systems control quality-critical processes – from development and production to quality control, regulatory approval and market surveillance.
DHC supports companies in establishing regulatory assurance as an integral part of their IT and corporate strategy – with scalable validation frameworks, structured governance models and efficient processes across the entire system lifecycle.
Challenges in GxP Compliance
Fragmented System Landscapes
Different IT systems, cloud platforms and laboratory applications make consistent validation difficult and increase integration effort.
Regulatory Requirements
GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 or the EU AI Act increase the effort for a permanently compliance-compliant system landscape.
Audit & Data Integrity Risks
Unclear governance, missing audit trails and incomplete documentation lead to inspection risks and costly remediation projects.
Integrated GxP Compliance for Modern IT Landscapes
GxP compliance must not be an isolated documentation project. In an increasingly digital and cloud-based system landscape, regulatory assurance must become an integral part of the IT and corporate strategy.
DHC supports companies in systematically anchoring GxP compliance in their organization – from strategy through implementation to long-term operations.
Key GxP Compliance Topics in the DHC Portfolio
GxP Compliance & Software Validation (CSV)
Compliance Check & Strategy
DHC analyzes your existing validation and compliance framework and evaluates it against current regulatory requirements. On this basis, we develop a scalable strategy for system validation, data integrity and audit readiness.
GxP Compliance Implementation
We support companies in the structured implementation of GxP compliance across the entire lifecycle of digital systems – from implementation through validation to audit readiness.
Typical services:
- Risk-based validation of SAP and non-SAP systems
- Creation and maintenance of validation documentation
- Data integrity assessments and remediation
GxP Compliance Services & Support
GxP compliance does not end at go-live. With Validation as a Service, we support companies in permanently maintaining the validated state of their systems – efficiently, scalably and audit-proof.
Why DHC – Your Specialist for GxP Compliance
For more than 30 years, DHC has supported companies in regulated industries in connecting GxP compliance and digital transformation. Our consultants combine deep regulatory knowledge with practical project experience and technological expertise.
GxP Compliance & CSV
Trust Through Experience
We are the specialist for GxP compliance.
“Due to their over 20 years of experience in IT compliance, very sophisticated validation concepts for SAP and ready-made documentation, we chose DHC as our validation partner. On November 13, 2019, we passed a 4-day FDA inspection without any findings – a great success.”
Frequently Asked Questions about GxP Compliance
What does GxP compliance mean for corporate management?
GxP compliance ensures that regulated business processes – such as development, production or quality control – meet regulatory requirements. For management, this primarily means minimizing risks to approval, market access and reputation through structured governance, validated systems and documented processes.
Why are IT systems today in the focus of regulatory inspections?
Digital systems increasingly control business-critical processes – from laboratory analyses and production control to batch release. Authorities therefore increasingly scrutinize system validation, data integrity, audit trails and governance structures. Without a structured compliance approach, companies risk inspection findings, delayed approvals and loss of market access.
What role does computer system validation (CSV) play for GxP compliance?
Computer system validation is the structured proof that an IT system is suitable for its intended purpose and meets regulatory requirements. It forms the basis for an audit-ready system landscape and is a central component of GxP compliance.
How do cloud and SaaS systems change GxP compliance?
Cloud and SaaS platforms offer high innovation speed but change the responsibilities between provider and user. Companies must therefore strengthen governance structures, supplier qualification and release management – within a clearly defined shared responsibility model.
What significance does data integrity have for companies?
Data integrity is today one of the most important inspection focus areas for authorities. Companies must ensure that data is complete, correct, traceable and permanently available. Concepts such as ALCOA+ and structured audit trails are central building blocks of a sustainable data integrity strategy.
What new regulatory requirements affect digital technologies such as AI?
With the EU AI Act and new guidelines such as the ISPE GAMP® AI Guide, structured requirements for the use of AI systems in regulated environments are emerging for the first time. Companies must therefore establish governance, risk assessment and monitoring of AI applications early – and integrate them into their existing compliance framework.
How can companies permanently ensure their audit readiness?
Audit readiness is not achieved shortly before an inspection, but through structured processes across the entire system lifecycle. This includes clear validation frameworks, regular periodic reviews, data integrity controls and a well-documented governance structure.
When is external support for GxP compliance worthwhile?
Many companies have individual compliance measures but no integrated governance model for their IT system landscape. External specialists support particularly in developing scalable validation frameworks, preparing for inspections and establishing sustainable compliance structures.
What role does GxP compliance play in digital transformation projects?
Programs such as ERP modernization, cloud migration or the introduction of AI systems fundamentally change the system landscape. If regulatory requirements are integrated into these projects early, validation effort, audit risks and subsequent costs can be significantly reduced.
GxP Compliance & CSV