installation
Certified installation to ensure compliance with regulatory and internal requirements
Your requirements are the focus of our customized installation services. We integrate your measurement devices seamlessly into your work environment and ensure precise and reproducible results right from the start.
Our qualified specialists will take care of the entire installation and provide you with comprehensive instructions on all functions. This allows you to effortlessly meet all regulatory and internal requirements. This ensures that internal and external regulatory requirements are reliably met.
We certify the entire system setup and device training on the basis of an installation protocol or with certified documents from the DQ-IQ-OQ-PQ qualification.
In order to meet different requirements, we have developed three graduated installation services that are precisely tailored to different application scenarios.
Contents
installation
Our service specialists will be happy to perform the installation of your new KRÜSS measurement instrument at your location.
After successful installation and functional testing, your employees will receive instruction and user training. We’re happy to answer any questions you may have during the installation and provide helpful expert advice. For example, you will receive professional tips for cleaning or calibrating your new measurement instrument. The entire installation process will be documented for you in a training log.
This installation package is suitable for all customers who work in compliance with GMP or ISO9000.
Services at a glance:
- Installing and setting up the device functions
- Installation and simple on-site functional testing
- Instruction and user training
- Documentation of the installation process, including a personalized training log
Installation, including IQ/OQ/PQ qualification
This installation process will be expanded to include a documented qualification of the new measurement instrument and extensive on-site testing.
The IQ/OQ/PQ service ensures that the necessary quality requirements for the measurement instrument and thus regulatory requirements are reliably met. The entire service is documented in a commissioning report and includes the following qualifications:
- Installation qualification (IQ): Documented evidence that your new device has been installed in accordance with GMP-critical requirements. Measurement and control technology, installed components, surfaces and add-on parts are tested.
- Performance qualification (OQ): Documented evidence that the system specifications are fully met across the entire measurement range.
- Performance qualification (PQ): Documented proof that all relevant system components and other relevant systems, comply with defined specifications and requirements during operation.
With this installation package, we support customers who are subject to regulatory requirements during the installation of their new measurement instruments, including, for example, guidelines from the European Union or the U.S. Food and Drug Administration (FDA).
Services at a glance
- Qualification sample documents for internal approval
- Comprehensive device qualification with detailed procedure description (flow chart)
- Method pre-configuration for required measurement applications
- Setting up routine checks and checks for the user applications
- On-site calibration with traceable norms and standards covering all important calibration parameters
- Comprehensive training and instruction for users and device managers
Installation in the pharmaceutical industry
The GMP-compliant manufacture of medicinal products and active ingredients is a prerequisite for successful marketing authorization. Quality assurance plays a crucial role here, as deviations in quality can have a direct impact on consumer health.
To comply with the strict guidelines of the European Union or the U.S. Food and Drug Administration (FDA), the measurement devices used must be qualified. The qualification is divided into four phases:
- Design qualification (DQ)
- Installation qualification (IQ)
- Performance Qualification (OQ)
- Performance qualification (PQ)
Our experts have developed a comprehensive range of services for installation in the highly regulated pharmaceutical sector. With our premium installation, we ensure that the necessary quality requirements for the measurement instruments and thus the official specifications are reliably met and documented. As a direct result, the necessary process validation has been completed successfully in the lab.
The installation (on-site service) for the highly regulated laboratory analysis complies with the requirements of the following guidelines:
- GAMP5
- GMP
- USP1058
- and 21 CFR Part 11
Services at a glance:
- DQ support by processing customer specifications
- Includes all necessary IQ/OQ/PQ services in the working environment of our customers
- Preparation of all necessary test reports, documents and certificates with traceable documents
- Including the provision of all certified test equipment required for qualification, as well as measuring, inspection, and special-purpose tools
- Also includes support for SOPs(Standard Operating Procedures) in accordance with security requirements related to audit trails, user management, and data integrity
- Including extensive application-related training for users
Supplementary information on DQ/IQ/OQ/PQ
Device qualification ensures laboratory operation according to reproducible procedures
All A.KRÜSS qualification solutions comply with the “risk-based” approach introduced at millennium. The devices are checked and installed by our experts using traceable test equipment. With a 4-step device qualification, you receive proof of quality and process reliability.
- The DQ is the documented proof that the planned design of the device is suitable for the intended use.
- The IQ confirms the complete, specified delivery and correct installation. Devices and their parts are identified, device configurations are verified and manufacturer specifications for trouble-free operation are documented.
- The OQ verifies that the device is operating as intended and in accordance with specifications. Users receive, among other aspects, useful information for the SOP (Standard Operating Procedure) and user training.
- The final PQ is the performance check of the devices according to a defined procedure. It provides proof that the DQ process requirements are fulfilled under real conditions. The goal is to approve the devices for laboratory use and ensure that they comply with the requirements of regulatory authorities, standards, guidelines, audits, and internal quality assurance.
Our qualification is designed to save you costs, resources and time in the process. Our specialists have years of experience in the calibration of measurement instruments and are familiar with the current regulatory requirements of applicable guidelines, standards, and laws. Below is a selection of the specifications that are important to us:
- EC GMP Guide
- cGMP rules for medical devices
- Good Automated Manufacturing Practice (GAMP) guidelines
- FDA-compliant qualification of systems (21CFR Part11)
- Pharmacopoeia or USP pharmacopoeia requirements
- DAkkS guidelines
- In accordance with the requirements of DIN EN ISO 17025
Our qualifications are carried out with a reduction of effort to a justifiable level, without piles of paper and with comprehensible documents.
Your advantages at a glance:
- You may request the documents for viewing in advance.
- We work with the necessary special tools and measuring equipment (traceable standards) and have a great deal of expertise in test equipment management, risk assessment and risk analysis.
- Digital devices are subject to strict data integrity checks. That’s why we initialize the correct and suitable device firmware configuration for you.
- We work with electronic signatures, by meaning the uniqueness of the combination of user ID and password.
- Data documentation is supported by a two-tier audit trail and audit trail log system.
- You will receive extensive training. This guarantees that all software applications integrate perfectly into your work processes.
Supplementary information DQ-IQ-OQ-PQ-installation
Documents
| Titel | Herunterladen |
|---|---|
| DQ-IQ-OQ-PQ-Qualifizierungen Fakten | HerunterladenVorschau |
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