Data integrity and compliance in measurement technology

Data integrity. Process validation. Audit security

For manufacturers of measurement technology, compliance with laws, standards, guidelines and norms is increasingly coming into focus. Central topics are: Process validation, data integrity and audit readiness.

The resulting requirements are diverse: measurement technology must guarantee data security in the digital laboratory environment, offer legal certainty and support quality-assured work.

As a manufacturer of measurement instruments KRÜSS Optronic produces devices that are also used in highly regulated areas. Our analytical instruments operate reliably in qualified laboratory environments, support validated processes and can be easily integrated into existing LIMS (Laboratory Information Management System) infrastructures.

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Future of Laboratory Work – Between Digitalization, Connectivity and Automation

Automation and digitalization are fundamentally transforming laboratory processes. This increases the requirements for transparency, security and traceability. Data must be validatable and protected against manipulation.

This means that data management and manufacturing practices are also increasingly subject to binding requirements. These include:

  • Requirements of national & international laws and guidelines such as Pharmacopoeia (e. g. B. Density measurement DS7000 series)
  • Requirements Code of Federal Regulations (CFR) of the USFood and Drug Administration (FDA)
  • Normative required functions, according to 21 CFR Part 11 and EU Annex 11 (with audit trail polarimeter P9000 series & refractometer DR7000 series )
  • Standards such as ISO, DIN or ASTM and WHO GMP guidelines
  • Good manufacturing practice / best practice – ensuring data security and the reproducibility & traceability of test results using proven and optimized procedures in accordance with industry guidelines (e.g. GLP, GMP, GAMP 5) (example: flame photometer)

Certified installation & DQ/IQ/OQ/PQ qualification

When you choose a measurement device from KRÜSS Optronic, receives far more more than just precise measurement technology. Extensive system functions support users even in meeting demanding regulatory requirements.

Further compliance requirements are guaranteed with a certified installation . Maximum operational reliability and long-term performance are also guaranteed. Three KRÜSS Optronic service packages are available. Below is a selection of the services included:

  • IQ (Installation Qualification) provides documented evidence that the instrument has been installed correctly in accordance with GMP‑relevant requirements. Measurement, control and regulation components, materials, surfaces and attachments are inspected.
  • OQ (Operational Qualification) is fully documented and ensures that a system operates reliably and consistently under defined operating conditions and according to specifications.
  • PQ (Performance Qualification) demonstrates that the system performs consistently within defined parameters over time and meets user requirements – a key step in the validation process.
  • Depending on the service package, customers receive all the necessary test protocols, traceability documents and certificates.
  • Calibration covers all relevant measurement parameters, is carried out using traceable standards and includes the provision of all necessary certified test equipment as well as measuring, control and special tools.
  • For the pharmaceutical industry, KRÜSS Optronic offers SOP(Standard Operating Procedures) support based on safety aspects of audit trail, user management and data integrity.

Modern measurement devices in the context of “good manufacturing practice”

To ensure the quality, safety and efficacy of products, food producers and life sciences industries operate in accordance with binding regulatory guidelines. These requirements define, among other things, processes, documentation obligations, measurement tolerances and technical specifications.

KRÜSS Optronic measurement devices comply with—and in many respects actively support—the regulatory frameworks commonly referred to as “GxP”, where the “x” represents various areas such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and others.

GMP (Good Manufacturing Practice)

The main GMP requirements are: Free from contamination, guaranteed traceability and reproducibility of measurement results. This includes, among other things, trained personnel, suitable facilities, laboratory environments and measuring instruments.

Also required are clearly defined manufacturing processes, reliable process control and analytics, as well as appropriate product storage and distribution.

The KRÜSS Optronic laboratory refractometers, polarimeters, density meters and flame photometers support these requirements.

GAMP 5 (Good Automated Manufacturing Practice, 5th Edition)

GAMP 5 – This is the definitive guide for the validation of computerized systems in GxP environments. Published by the ISPE (International Society for Pharmaceutical Engineering), GAMP 5 provides a risk-based approach and best practices to ensure that software systems – from simple Excel spreadsheets to complex software environments – are effective, reliable and compliant.

User‑friendly technology with data security

https://youtu.be/vfUGfIGdTA4

For a constantly evolving field such as digital measurement technology, user‑friendliness is essential:

  • The measurement systems should be easy for operators to use and provide clear benefits for day‑to‑day work.
  • What is needed are intuitive functions that guide users safely through measurements and generate reproducible data.
  • To ensure this, our DR7000 series refractometers measure with completely new assistance systems. The new P9000 series polarimeters additionally feature an internal sample camera and RFID recognition.

21 CFR Part 11 and EU Annex 11 – Requirements for electronic records & signatures

Anyone working digitally in the pharmaceutical world must meet the requirements of 21 CFR Part 11 and EU Annex 11 when generating and storing measured data. What is required:

  • Complete traceability: The origin of electronically generated measurement values must be fully transparent. Measurements must be exactly reproducible.
  • Tamper-proof storage: It is mandatory for electronic data to be stored permanently, securely and unalterably.
  • Data integrity & authorization levels: Different levels of access rights are required to ensure that only authorised individuals can create, review or export electronic data.
  • Data export: All electronic data and measured values can be exported completely and securely, including to existing LIMS infrastructures.
  • Immutable audit trail: A non-editable, non-deletable audit trail is mandatory. Every action must be clearly documented, and a comment function ensures maximum transparency.
  • Legally valid electronic signatures: These completely replace traditional paper signatures.
    Result: Accelerates processes with maximum security and support for digital workflows.

The following KRÜSS Optronic measurement devices, for example, are compliant with 21 CFR Part 11 and EU Annex 11: flame photometers; polarimeters (P9000-P series, P8000 series); laboratory refractometers(DR7200-P, DR7400-P and DR6000-TF); density meters and gas analysers.

The practice: Data management of measurement results

Data integrity is now absolutely essential and has increasingly become a central focus of audits and the validation of analytical procedures. It refers to the complete, accurate, consistent and timely recording of laboratory data.

  • Data must be attributable, legible and original. An e-signature and a time stamp guarantee the accuracy and currency of all records.
  • If the measurement device features an audit trail, traceability is fully ensured.

Our measurement devices with audit trail document WHO, WHEN, WHAT, HOW and WHY with data from sample measurements. This ensures data integrity and regulatory compliance with legal requirements, standards and guidelines in numerous respects.

Here is an overview of the functions that ensure the data integrity of our laboratory refractometers(DR7200-P, DR7400-P and DR6000-TF); flame photometers, polarimeters (P9000-P series, P8000 series); density meters and gas analysers.

Functions for data security
Data printout GxP-compliant printout of data and device settings, fully traceable
Tamper-proof Tamper-proof thanks to individual authorization of the time and date setting
Data transmission Data transmission using standard protocols (LAN, network share protocol)
Unique and non-confusable assignment of user account
User accounts Creation and identification of users at three predefined levels (User, Application Administrator, System Administrator)
User account login Each user account has a unique combination of name and login information to correctly and uniquely identify the user account
Password security Enhanced security through complex passwords (letters, numbers, special characters) and individual, defined expiry periods
Extended compliance functions
Raw data access Possibility to access raw data and save raw data
Functions for complete traceability of measurement results
Measured value storage All measurement results are saved together with all method settings so that results are fully traceable
Data import and export
Signed & protected import Only files that are signed and recognized as permissible by the system can be loaded and processed by the system
Interfaces Configuration It is possible to define the interfaces for export and import system-wide.
Note: If a interface is not selected, it is not possible to export and import to it.

Audit readiness starts with reliable measurement technology

Audits are independent assessments of systems, information, organizations or processes. In day‑to‑day operations, they are often perceived as an additional compliance burden and can lead to uncertainty regarding documentation requirements and process conformity.

However, audit readiness is a key success factor and creates clear competitive advantages: it strengthens security during internal and external audits and demonstrably reduces the risk of non-conformities. As a result, companies operate more efficiently, more reliably and with greater regulatory assurance — a benefit that builds trust and strengthens market position.

Audit readiness requires the right technology. The targeted selection of measurement devices, the appropriate configuration and qualified installation(IQ/OQ/PQ documentation) play a decisive role in supporting audit preparedness.

KRÜSS Optronic incorporates regulatory requirements, audit‑relevant functions and compliance expectations right from the development stage of its measurement instruments and their software.

Our laboratory refractometers, density meters, flame photometers, polarimeters and gas analysers can be seamlessly integrated into existing processes – and strengthen audit readiness in the long term.

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