Quality & Compliance
In the plasma environment, every requirement counts
Our solutions are developed to GMP/GxP standards and undergo documented computer system validation.
Our quality management system is certified to ISO 9001. Rigorous data protection and clear policies – including responsible use of AI guided by the requirements of the EU AI Act – are a matter of course for us.
We are currently establishing an information security management system in accordance with ISO 27001. Until certification, we already work by the underlying principles – confidentiality, integrity and availability of the data entrusted to us.
For us, compliance is not an afterthought but part of development: documented, traceable and auditable.
Reliability
What you can rely on
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GMP / GxP
Development to the standards of the regulated environment.
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Computer system validation (CSV)
Documented validation of computer systems.
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Quality management (ISO 9001)
Certified to ISO 9001 – clean processes and traceable documentation.
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Data protection & AI
GDPR-compliant, with clear policies on the use of AI.
Contact
Ready for a secure, specialised IT foundation?
Talk to us about your requirements – we’ll show you how BPMS and our end-to-end service work in your centre.