The demands placed on modern measurement technology are increasing rapidly: data consistency, process validation, audit security and compliance with international GxP guidelines are at the heart of digital laboratory work today. To provide companies in regulated industries with the best possible support, KRÜSS Optronic is now providing a detailed information page that clearly summarizes all relevant compliance topics.
Why data integrity information is important
With the increasing digitalization of laboratory processes, the requirements to reliably meet legal specifications such as 21 CFR Part 11 and EU Annex 11, ISO standards, GMP, GLP or GAMP 5 are growing. At the same time, measurement devices must provide tamper-proof data, be auditable and integrate seamlessly into digital infrastructures such as LIMS systems.
KRÜSS Optronic sees itself as an innovation partner for high-precision measurement instruments
Our new information page shows how KRÜSS Optronic supports these requirements – from measurement technology and data management to qualified installation(DQ/IQ/OQ/PQ). The contents provide a clear overview of:
- Legal and normative requirements(FDA, Pharmacopoeia, ISO, DIN, ASTM, WHO, GMP)
- Data security, audit trails and electronic signatures
- Compliance functions of our measurement devices (e.g. refractometers, polarimeters, density meters, flame photometers)
- GxP-compliant processes and best practices
- Qualification and service packages for maximum operational reliability
- Modern assistance systems for safe, reproducible measurement processes
This gives laboratory managers, quality managers and compliance teams quick access to all relevant information that is crucial for regulated working environments.
More security, more transparency, more sustainability
KRÜSS Optronic shows what modern measurement technology must look like today: user-friendly, digitally networked, auditable and regulatory compliant. The new information on data integrity serves as a central knowledge base for anyone who wants to find out about compliance requirements and suitable solutions.
KRÜSS Optronic measurement devices compliant with 21 CFR Part 11 and EU Annex 11
We support you with product and application questions - by phone, on site or at our training center in Hamburg.
All new information is for initial information purposes. You can also find out which ones are suitable for you and your measurement devices in a personal consultation or product demonstration. Please feel free to contact us.
We also offer special monthly online product demonstrations, all current dates can be found here.