Life Science Software for Pharma & Biotech - Quality Management Solution

Work according to stringent regulations

We help you ensure inspection readiness in the heavily regulated pharmaceutical and biotech industry. Your quality and compliance data is stored in one highly secure place; our easy-to-use and centralized platform. Life science data management is our specialty, and our expertise to meet the strict demands of the pharma sector is unparalleled. Rest easy knowing our software is updated frequently based on the very latest regulatory requirements, allowing you to always work in compliance with new ISO 27001, ISO 15189, ISO 17025, GMP, GDP and GLP regulations.

Total control over documentation

Gain full governance over your pharma and biotech quality and operational documents with our flexible, powerful, and strikethrough customizable document management system. Document version control and update management becomes a breeze with features like automatic notifications, compliant e-signatures, and controlled printing and reconciliation. We support you in creating clear approval cycles, custom quality management workflows, and much more with our configurable modules. Say hello to a centralized, categorized and compliant system.

Dedicated training management

Intelligent and automated training within our central platform keeps your whole company compliant. Benefit from effortless storage of training records, automated training reminder notifications, automatically triggered retraining depending on employee role, a detailed training matrix, and more. Be assured that employees understand training materials through compliant e-signatures or set up custom pop quizzes and surveys. Our platform offers a complete solution for all your pharma and biotech training requirements.

Digitally streamline your quality processes

Document control, proper quality management, and adhering to regulations becomes much easier when data is hosted in one safe place. Our platform is entirely cloud-based, meaning your data is accessible from any device, anywhere in the world, while remaining highly protected and encrypted. Gone are the headaches (and significant human error risks) from having a disparate or a partly paper-based system. We help you build your own workflows, and automate many facets of your processes. Any GxP papers that are printed remain controllable and reconcilable. Finally, an efficient system at your fingertips.

Multi-Audit Success

While working in the pharma and biotech arena, you'll face many different audits; internal, external, supplier audits, you name it. Thankfully, risk assessment and compliance is infused into our platform, and that helps you maintain a clear audit trail according to 21 CFR 11. We guide you towards total inspection readiness, through effective implementation of CAPAs, to compliant e-signatures and approval workflows, to painless assignment and follow-up of compliance trainings. Our platform encourages transparency and traceability at all times.

Full compliance with 21 CFR part 11 and GAMP5

Validating in pharma and biotech is costly and time-intensive. We offer fully validated quality management modules that remove that hassle from you. Our software is pre-validated according to GAMP5 and 21 CFR part 11. Pick and choose the modules you need to build up a completely custom, and fully cloud-based, compliant system. Our software is regularly updated, so you can keep on track with the latest pharma and biotech regulations at all times. We’re here by your side to ensure total compliance.