Pharma & Biotech:
DHC Industry Expertise for Digitalization and Transformation
Consulting solutions and tools for SAP Life Sciences, GxP Compliance (CSV) and Quality Management with SAP
- SAP, IT, and Compliance Expertise
- SAP Silver Partner
- 800+ Successful Projects
- 30+ Years of Experience
Challenges in the
Pharmaceutical and Biotech Industry
Leveraging SAP Innovations in a GxP‑Compliant Way
SAP transformations, AI deployment in ERP and cloud services are increasing the pace of change – the challenge is to maintain GxP compliance demonstrably at all times.
Data Integrity Across the Entire Process Chain
Audit risks often arise at interfaces and workarounds between SAP and third-party systems – what matters is an end-to-end, auditable data and event chain.
New AI Regulations & GAMP Guidance
Established frameworks (GAMP 5, EU GMP Guidelines incl. Annexes, FDA 21 CFR Part 11, ICH …) are currently being supplemented by new AI regulations and guidelines (EU AI Act, ISPE GAMP AI Guide, Annex 22)
IT Innovation and GxP Compliance in Regulated Environments
Pharmaceutical and biotech companies face the challenge of balancing innovation in R&D, reliable supply capabilities and cost efficiency with stringent quality and GxP compliance requirements. At the same time, digitalization, automation, cloud technologies and artificial intelligence are increasing the speed and complexity of changes in processes and IT.
Digital systems control central processes along the entire product lifecycle – from development through production and quality assurance to regulatory approval. Topics such as GxP compliance, data integrity and computer system validation (CSV) are business-critical to ensure product quality, patient safety and audit readiness at all times.
With over 30 years of experience in the pharmaceutical industry, DHC helps companies safely connect transformation and regulatory requirements. We modernize system landscapes, integrate data and processes, and implement regulatory requirements efficiently.
We combine deep industry and process expertise with SAP Life Sciences, GxP Compliance (CSV) and Quality Management with SAP. This is how we create seamless, harmonized end-to-end processes and embed regulatory assurance sustainably – as a stable foundation for efficient operations, audit readiness and continued growth.
DHC Consulting Solutions and Tools
Integrated SAP S/4HANA Transformation & Validation
The transformation to SAP S/4HANA presents pharmaceutical and biotech companies with unique challenges: In addition to technological and process changes, regulatory requirements must be consistently addressed. At the same time, existing system landscapes need to be harmonized and future-proofed.
Whether a new implementation or a migration from SAP ERP to SAP S/4HANA: DHC supports you in executing your S/4HANA transformation and validation safely, efficiently and in an integrated manner – from strategy to go-live and beyond. We combine transformation expertise with deep understanding of GxP-regulated environments, creating the foundation for stable, integrated and auditable digital processes.
Our services:
- Strategy and roadmap for SAP S/4HANA under GxP requirements
- New implementation of SAP S/4HANA
- Selection and execution of suitable transformation approaches (Brownfield, Greenfield, Selective Data Transition)
- Planning and execution of integrated transformation and validation strategies for SAP S/4HANA
- Integration of existing systems and data migration in regulated environments
- Support for SAP cloud transformations (e.g. RISE with SAP) under compliance aspects
→ Learn more about SAP S/4HANA Transformation
GxP Compliance & Computer System Validation (CSV/CSA)
Computer system validation is a central building block for ensuring product quality, patient safety and regulatory compliance. At the same time, increasing digitalization raises the demands on the efficiency and sustainability of validation processes.
Based on more than 30 years of industry experience, DHC supports you in implementing GxP compliance and validation in a practical, risk-based and efficient manner – for SAP and non-SAP systems alike.
Our services:
- Development and optimization of CSV and CSA (Computer Software Assurance) approaches
- Risk-based validation of SAP and non-SAP systems
- Creation and maintenance of validation documentation along the system lifecycle
- Support during audits and inspections (e.g. FDA, EMA)
- Remediation measures and sustainable anchoring of compliance structures
→ Learn more about Computer System Validation
Digitalization of Validation (DHC Smart Validation Accelerator)
Increasing system complexity and growing regulatory requirements demand new approaches to make validation efforts more efficient. Standardized, digital solutions offer significant potential in this area.
The DHC Smart Validation Accelerator is an innovative digital validation platform for regulated companies. Through the use of artificial intelligence (AI) and full integration into the SAP ecosystem – particularly as a solution extension to SAP Cloud ALM and in combination with test automation – it significantly increases the efficiency of your validation processes.
Our services:
- Digitalization and automation of validation processes
- Use of standardized templates and best practices
- Acceleration of testing and documentation processes
- Reduction of manual effort and error sources
- Integration into existing system and process landscapes
- Implementation of the proprietary validated DHC software solution for digitalization & automation of your validation processes
→ Learn more about the DHC Smart Validation Accelerator
Data Integrity & Audit Trail
Ensuring data integrity is a central prerequisite for GxP compliance, audit readiness and informed decision-making in regulated environments. At the same time, many companies face the challenge of digitizing legacy, partly paper-based processes and transitioning them into integrated system landscapes.
DHC supports you in sustainably ensuring data integrity and efficiently digitizing regulatory-relevant processes. We combine regulatory requirements with technological expertise, creating the foundation for transparent, consistent and auditable data along the entire product lifecycle.
Our services:
- Conducting data integrity assessments (e.g. according to ALCOA+ principles)
- Identification and evaluation of risks in data flows and interfaces
- Digitalization and standardization of paper-based and manual processes
- Design and implementation of integrated data and system landscapes
- Establishing sustainable governance structures for data integrity
→ Learn more about Data Integrity
Audit Readiness & Inspektionssicherheit
Regulatory inspections by authorities such as the FDA or EMA represent a critical test for pharmaceutical and biotech companies. At the same time, complex system landscapes, increasing data volumes and evolving requirements intensify the pressure to maintain audit readiness at all times.
DHC supports you in systematically building and sustainably embedding audit readiness and inspection preparedness. We help you identify potential weaknesses early, address them in a targeted manner and optimally prepare your organization for audits and inspections.
Our services:
- Conducting mock audits and inspection preparations
- Identification and evaluation of compliance gaps (gap assessments)
- Support during FDA and EMA inspections
- Development and implementation of remediation measures
- Establishing sustainable structures for continuous audit readiness
→ Learn more about Audit Readiness & Inspection Preparedness
IDMP with SAP
With the Identification of Medicinal Products (IDMP), pharmaceutical companies must submit comprehensive structured product data to authorities such as the EMA.
DHC supports pharmaceutical companies in efficiently implementing IDMP requirements with SAP – from data strategy through implementation to compliant system operation.
→ Learn more about Identification of Medicinal Products (IDMP)
Quality Management with SAP (LIMS / eQMS)
Integrated quality management is essential for efficiently meeting regulatory requirements while ensuring stable, transparent processes. In many companies, the challenge lies in consistently and seamlessly mapping QM processes within their systems.
DHC supports you in holistically designing your quality management with SAP and optimally integrating it into your system landscape.
Our services:
- Implementation and optimization of SAP QM in regulated environments
- Integration of quality processes into adjacent SAP modules
- Introduction and further development of LIMS and eQMS solutions
- Mapping of central QM processes such as deviations, CAPA and change control
- Harmonization and standardization of QM processes across sites
→ Learn more about Quality Management with SAP
Implement Transformation safely – Ensure Compliance at all Times
Let us analyze your challenges together and develop concrete solutions for your organization.
