GxP-Compliant Software Development for the Pharmaceutical Industry
In the highly regulated pharmaceutical industry, the digitalization of critical business processes is increasingly determining companies’ competitiveness. cube one GmbH has established itself as a specialist for GxP-compliant software solutions and supports pharmaceutical companies in the digital transformation of their regulatory and operational processes. With over 10 years of experience in developing validation-required systems, we offer scalable software solutions specifically tailored to the complex requirements of the pharmaceutical industry.
Our Services:
- Custom Software Development: Whether you need a new application, a complex system, or a tailored solution for your business requirements – we develop software precisely aligned with your wishes. From the first idea to the finished product, we guide you through the entire development process.
- System Integration: Optimize your business processes through seamless integration of different systems. We help you efficiently connect existing software solutions and create a future-proof architecture.
- Software Maintenance and Support: Your software’s success doesn’t end with implementation. We offer long-term support and maintenance to ensure that your solution remains current and performant. We are also quickly available to assist you with any emerging problems.
- Consulting and Project Management: Benefit from our software development expertise. We advise you on the best technologies and methods for your project and ensure that your software solutions are implemented efficiently, on schedule, and within budget.
Your Strategic Advantage:
- Industry-Specific Expertise: cube one GmbH possesses specific know-how in the pharmaceutical industry and understands the industry’s unique regulatory requirements and compliance regulations.
- Compliance Conformity: Validated development according to regulatory guidelines (FDA 21 CFR Part 11, EU-GMP Annex 11, PIC/S) minimizes compliance risks and reduces potential audit findings by regulatory authorities.
- TCO Optimization: Through needs-based software design, Total Cost of Ownership is significantly reduced – no licensing costs for unused features as with Commercial-off-the-shelf (COTS) products.
- Enterprise Application Integration (EAI): Cross-system integration via standardized interfaces (APIs) maximizes automation rates and minimizes manual process costs.
- Low-Code Development: For limited use cases, cost-efficient Microsoft Office-based automations are implemented via VBA, significantly reducing development costs.
- Future-Proof Architecture: Implementation according to Clean Code principles and use of future-proof technology stacks minimizes technical maintenance efforts and later refactoring costs.
- End-to-End Process Automation: Enables complete automation of repetitive tasks, thereby freeing employees for value-adding activities and increasing process speed. The systematic elimination of human error sources through automated processes leads to a demonstrable reduction in quality-related costs while simultaneously minimizing compliance-relevant risks.
Contact us today to learn more about our tailored IT solutions for the pharmaceutical sector.
Custom Software Solutions and Process Automation
We maximize your efficiency through precise software solutions and intelligent automation. Our spectrum ranges from tailored applications and scripts that optimize your specific workflows to complex cross-system integrations.
- API-Development: For highly specialized tasks, we develop performant and robust APIs that ensure seamless data communication and process integration.
- Script-Based Automation: We automate repetitive tasks through powerful scripts (e.g., Python, PowerShell), reducing manual efforts and minimizing error sources.
- Individual Software Components: We extend existing systems with precisely fitting software modules that are exactly tailored to your requirements – without unnecessary overhead.
- Database-Supported Applications: We create database applications for you that enable efficient data management and processing.
- Low-Code/No-Code Solutions: We offer efficient Low-Code/No-Code solutions that can be agilely adapted to dynamic requirements.
Increase your productivity, reduce costs, and secure a competitive advantage through our expertise in precisely tailored software development and automation.
Database Solutions
We design and implement powerful data management solutions precisely tailored to your requirements – from conceptualizing relational architectures to developing customized database applications.
- Relational Databases (RDBMS): We master the leading SQL database systems (including Microsoft SQL Server, MySQL, PostgreSQL, Oracle, Firebird, SQLite) and design high-performance, scalable, and secure data models that optimally support your business processes.
- Database Development: We develop individual database applications or frontend solutions for efficient data capture, processing, and analysis.
- Data Modeling & Optimization: We create logical and physical data models, optimize existing databases for maximum performance, and develop efficient queries and stored procedures.
- NoSQL Database Expertise: We are proficient in the latest data storage technologies and find the technology that best suits your use case.
- Data Migration & Integration: We safely and losslessly migrate your data between different database systems and ensure seamless integration with your existing applications.
- Hybrid Data Storage: We combine the technologies that best suit your needs to achieve the optimal result.
- Rapid Prototyping with Microsoft Access: For smaller applications and quick prototypes, we leverage the advantages of Microsoft Access to deliver cost-efficient and timely results. We develop both the backend (data storage) and frontend (user interface). Access solutions are particularly suitable for scenarios where rapid implementation and utilization of the existing Microsoft Office infrastructure are paramount.
Maximize the Value of Your Data. Benefit from our expertise in the conception, development, and optimization of database systems that accelerate your business processes and improve your decision-making.
Agile Project Management & Lifecycle Support
We master both classical and agile project management methods (e.g., Scrum, Kanban) and flexibly adapt our approach to your specific project requirements. We offer comprehensive support throughout the entire software lifecycle:
- Requirements Analysis & Conception: We precisely capture your requirements, create technical concepts, specifications, and system architectures, always considering regulatory guidelines.
- Implementation & Testing: We develop high-quality software according to Clean Code principles, conduct comprehensive tests (unit, integration, system tests), and ensure code quality through reviews.
- Validation and Documentation: We support you in software validation and create GMP-compliant documentation.
- Deployment & Go-Live Support: We accompany the introduction of your software, train your employees, and remain at your side with advice and support even after go-live.
- Maintenance, Support & Further Development: We ensure long-term operation of your software, resolve errors, implement new features, and adapt the solution to changing requirements.
Our goal is to realize your software projects on time, within budget, and of the highest quality – from the first idea to long-term operation.
FAQ on Software Development in the GxP Environment (SDLC)
SDLC stands for Software Development Life Cycle. In the GxP environment, the SDLC is not just a development process, but a regulatory-required framework that ensures software is developed in a quality-compliant and validated manner from planning through to decommissioning.
The most important difference is the strict documentation requirement and the need for traceability. Every step in the SDLC must be documented to prove at any time that the software meets the User Requirement Specification (URS) and is regulatory compliant (e.g., proof of tests for each requirement).
Requirements management is fundamental. All requirements (URS, FS – Functional Specifications) must be clear, testable, and approved. They form the basis for the entire validation. All developed functions must be directly traceable to a documented requirement.
Both are fundamentally possible, however the classic V-Model is often preferred as it enables a clear mapping of specification and testing phases. Agile methods (e.g., Scrum) can be used but require additional controls to ensure continuous documentation, traceability, and version control in each sprint.
When using Commercial Off-The-Shelf (COTS) software, a supplier assessment (Supplier Audit) must be conducted to ensure that the manufacturer has an adequate quality management system. The software must then be configured and validated to demonstrate that it is suitable for the specific GxP application.
Risk assessment occurs at the beginning of the project and continuously thereafter. It serves to identify the critical functions of the system that have a direct impact on product quality and patient safety. The testing and validation effort is set directly proportional to the identified risk.
Test specifications define what and how testing should be performed. Test protocols (or test reports) are the documented records of the tests performed. They must contain the test results, deviations, corrections, the electronic signature of the tester, and the approval by quality assurance.
Any change to requirements, code, or configuration must follow a formal change control process. The change must be assessed, documented, approved, and fully tested in the development environment before being transferred to the production environment. This includes evaluating the need for re-validation.
Version control is the obligation to uniquely identify, track, and log changes to all development elements (code, documents, requirements, test scripts). It ensures that at any time it is clear which approved version of the system is in GxP operation.
QA has a supervisory and approving role. It is not directly responsible for development, but for the final approval of all critical validation documents (validation plan, test protocols, validation report). QA confirms that the entire SDLC has been conducted in accordance with internal SOPs and external regulations.
