QMS for Life Sciences:
Secure, Scalable & Compliant
We provide specialized software solutions tailored to the rigorous demands of the life sciences industry.
With our comprehensive eQMS and premium services, our team empowers your business to manage QM processes with maximum efficiency and security.
We provide specialized software solutions tailored to the rigorous demands of the life sciences industry.
With our comprehensive eQMS and premium services, our team empowers your business to manage QM processes with maximum efficiency and security.
Leverage Our Industry Expertise
Benefit from our years of experience in the regulated life sciences sector. We provide specialized solutions designed specifically for the high standards of pharma, medtech, and medical devices, backed by premium quality assurance services.
See how our eQMS provides the ideal solution for various players across the pharma sector:
- Pharmaceutical Manufacturers
- Contract Manufacturers / CMOs and CDMOs
- Suppliers and Services
- Pharma Logistics and Trade
- Pharmacies
Our GxP-compliant solutions for pharma offer core features such as audit-proof document control, complete audit trails, CAPA, electronic signatures, and risk-based validation to ensure compliance and efficiency.
Pharma
Our eQMS is perfectly tailored to the needs of medical device manufacturers, suppliers, and service providers.
- Medical Device Manufacturers
- Medical Device Suppliers
- Logistics Service Providers for Medical Technology
- Medical Device Trade and Distribution
- Medical Device Service and Maintenance
- Software Providers / SaMD (Software as a Medical Device)
Industry-specific solutions for seamless management and full compliance with MDR and ISO 13485. Master MDR challenges with automated document control, streamlined CAPA workflows, and intelligent supplier qualification.
Medical Devices
Our eQMS provides the perfect digital infrastructure for the following biotech industry segments:
- Biotech Production Companies (Biopharmaceuticals, Biomaterials, AgBiotech, Functional Foods)
- Contract Manufacturers / CMOs and CDMOs
- Biotech Logistics Providers
- Biotech Trade and Distribution
Our eQMS offers biotech companies fully automated GxP workflows. With integrated document control, our eQMS guarantees seamless ISO 17025 compliance.
Biotech
Our software provides the perfect fit for these research institutions:
- Academic and industrial research laboratories
- Medical diagnostic laboratories
- Testing and quality control (QC) laboratories
- Contract research organizations (CROs)
ISO 17025, GLP, and GCP implemented seamlessly and audit-proof – with our QM software for research laboratories, you save time, minimize risks, and master audits effortlessly.
Research and Laboratories
Explore our track record and see how our flexible solutions can streamline processes across the life science sector.
Why Do Life Science Companies Need Specialized QM-Software?
Specialized software for complex markets
Spezialisierte Software für komplexe Märkte
In pharma, medtech, and labs, ‘off-the-shelf’ falls short.
While generic tools struggle to keep up with rigorous regulatory requirements, specialized software gives you the lead: total compliance, zero hassle.
Move past rigid systems that don’t fit your needs. A specialized eQMS takes that weight off your shoulders.
It isn’t just another system; it is a validated, end-to-end solution that truly understands how your industry works.
Save time and effort on GxP-documentation with the help of our QMS. Your benefits at a glance:
Secure compliance with GxP requirements
Leverage industry-specific features and modules
Define industry-specific workflows
Optimize QM-processes and workflows
Improve traceability and auditability
Implement role-based access
Ensure data integrity and security
Successfully navigate audits and inspections
Prevent manual errors within the system
Overcoming Compliance-Challenges in Life Sciences
Our software transforms complex regulatory requirements into active processes, ensuring that life science companies maintain compliance with FDA, MDR, ISO 13485, and GxP in a secure and verifiable manner. With our digital QMS, you are prepared for every audit.
Leverage seamlessly documented processes, standardized forms, and electronic signatures within your system to ensure the consistent application of all regulations and face future audits with confidence.
Reliable compliance for the life sciences industry
Sichere Compliance für die Life Science Industrie
From Paper to Digital: QMS for Life Science Teams
Modern management requires scalable solutions. Digitalize your QM-processes quickly and securely. Transition from manual errors to automated workflows with a digital system. Our optimized QMS boosts quality across all management levels, ensuring total security with seamless audit trails.
Our software enhances your QMS through automated sign-offs and smart features that speed up processes and eliminate system-wide versioning conflicts.
Trust Our Expertise In Digitizing Your Quality Management
Our experienced team supports you with tailored services during the introduction of your new eQMS. From initial implementation to ongoing support—our service guides you securely through every process.
SOP-Guard
Document control reimagined: Find instead of search – always up to date.
- Centralized administration of all quality-relevant documents (SOPs, work instructions, specifications, reports)
- Strict version control with revision history
- Configurable workflows and approval processes
- Electronic signatures and audit trails
- Linking SOPs with change management, deviations, and CAPAs
FORM-Guard
Your success begins with the professional management of QM-processes.
- Automated workflows for CAPA, Change Control, and Deviations
- Deadlines and escalations
- Flexible drag-and-drop configuaration
- Electronic signatures
- Role-based access control
SKILL-Guard
Take your training management to a new dimension.
- Automated qualification matrix
- Training planning and assignment
- eLearning and LMS
- Electronic signatures and training records
Our QMS provides exactly the industry-specific features you need to ensure uncompromising product safety and compliance with all standards. Get started with a demo and see how our eQMS and specialized features can benefit you.
Document Control
Process Management
CAPA & Action Management
Audit Management
Audit Trail
Supplier evaluation and qualification
Change Management and Change Control
Deviation Management
Training matrix and integrated LMS
Automated notifications
Role-based access control
Integration with other systems and tools
Expert Service And Support That Goes Beyond Just Software
We provide more than just a ready-to-use QMS. We see ourselves as your long-term partner. Our expert team actively guides you through the implementation of your system, ensuring that all processes – from the management of critical data to daily application – integrate seamlessly.
With our expert support, you are perfectly prepared for every audit. We provide the system maintenance and expertise you need to focus confidently on your core business.
Build an audit-ready eQMS with our industry expertise. Take your quality management to the next level. Consult with us today.
Our services at a glance
Introductory workshops
Individual consulting
Maintenance and updates
Expert service and support
Key-user training
Webinars and continuing learning
What you need to know about qm-software for life sciences—answered concisely.
Our QM software for life sciences fully supports all relevant standards and regulations -including ISO 13485, ISO/IEC 17025, ISO 22716, ISO 9001, GMP, GLP, GCP, FDA 21 CFR Part 11, and EU-MDR Annex 11. Benefit from a proven management system that ensures audit readiness and seamless compliance for your business – validated, scalable, and future-proof.
Designed for the life sciences industry, our QM software enforces GxP compliance via seamless audit trails, electronic signatures, and granular access control. These capabilities safeguard your business, mitigate audit risks, and drive process efficiency.
Our qm-software is fully validatable and offers comprehensive support, including individual validation packages for computer system validation (CSV) according to GAMP 5. Save time and resources in your business while meeting the highest compliance standards.
