DHC Business Solutions

DHC Business Solutions develops regulatory technology software for organisations operating in highly regulated industries. The company's core focus is on quality management, quality assurance, and regulatory compliance, delivered through its main product lines DHC VISION (covering QxP and CxP modules) and the VxP validation platform. Its solutions are designed to digitise controlled documents, manage quality processes, and support compliance requirements across sectors including pharmaceuticals, medical devices, and financial services.

DHC Business Solutions serves a broad range of customers — from established enterprises to startups — providing modular, compliance-conformant software with a modern user experience. Customers include Verla-Pharm Arzneimittel and VitalAire GmbH, among others. The company also offers consulting services, particularly around validation in regulated environments, and provides templates and documentation support alongside its software products.

Core Product Areas

• Regulatory Quality (DHC VISION QxP): An integrated software suite for quality management and quality assurance, focused on the digitalisation of controlled documents and quality assurance processes.
• Regulatory Compliance (DHC VISION CxP): Solutions designed specifically for the financial industry, covering the management of the written fixed order (Schriftlich fixierte Ordnung, SFO) as well as policies and guidelines management.
• Validation Platform (VxP): A cloud-based, pre-validated solution for automating validation processes and digitally managing validation documents.
• Regulatory Quality for Startups: A version of DHC VISION tailored for startups and young companies, enabling early establishment of a digital quality management system (QMS) without licence costs, deployable out of the box and immediately compliance-conformant.

Software Modules

• SOP Control: Digital management and control of standard operating procedures and prescriptive documentation, conformant with regulatory requirements including 21 CFR Part 11.
• Training: A seamlessly integrable complement to SOP management, supporting digital training compliance processes.
• Learning Success (Lernerfolg): Verifies comprehension at the end of SOP closed-loop processes, going beyond simple read-and-understood confirmations.
• CAPA: Automated management of corrective and preventive actions, ensuring no measure is overlooked through to full implementation.
• Deviations (Abweichungen): Systematic and controlled documentation, analysis, and resolution of deviations to improve quality and regulatory adherence.
• Complaints (Reklamationen): Controlled management of customer complaints, supplier complaints, and internal complaints, with a high degree of regulatory process security.
• Change Control (Änderungen): Management of change control system processes, ensuring precise control and communication of changes from initiation to completion.
• Audit: A fully digital and user-friendly audit process module, designed as an integral component of an integrated management system.
• Policies (Richtlinien): Digital creation, maintenance, and communication of internal policies and procedures in a controlled and traceable manner.
• SFO (Schriftlich fixierte Ordnung): Supports fulfilment of legal requirements and ensures proper business operations, particularly for the financial sector.
• Processes (Prozesse): Combines process management concepts with a document management system (DMS) and risk management functionality that exceeds standard requirements.

Key Capabilities and Notable Details

• Software is designed with high modularity, allowing organisations to adopt individual modules according to their needs.
• All solutions are built with consistent regulatory compliance conformance as a core design principle.
• The validation platform is cloud-based and pre-validated, reducing the burden of validation activities for customers in regulated environments.
• DHC Business Solutions provides consulting services alongside its software, with consultants experienced in regulated environments, including support for validation documentation and implementation.
• The company has been recognised by the German Research Allowance Certification Body (BSFZ) for its in-house research and development activities.
• DHC publishes educational content on topics such as Standard Operating Procedures (SOPs), including a ten-part article series covering SOP fundamentals for quality-driven organisations.
• The company is headquartered in Saarbrücken, Germany.

DHC Business Solutions positions itself as a provider of end-to-end regulatory technology, combining software products, pre-built templates, and domain-specific consulting to help organisations in regulated industries achieve and maintain digital quality and compliance management.