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Latest News

Kapelan Bio-Imaging Successfully Certified to ISO 13485

March 18, 2024
Quality Management Meets Legal Requirements, Qualifies Kapelan Bio-Imaging as Provider of Medical Device and IVD Software

 

Leipzig, Germany, 240313: Kapelan Bio-Imaging is pleased to announce that the company has successfully passed the surveillance audit for ISO 13485. This certification confirms that Kapelan Bio-Imaging’s quality management meets legal requirements and qualifies the company to provide software for medical devices and in vitro diagnostics (IVD).

ISO 13485 is an internationally recognized standard specifically developed for organizations in the medical device industry. It sets requirements for a quality management system to ensure that products and services meet the stringent requirements of the medical industry.

By successfully completing the surveillance audit, Kapelan Bio-Imaging has demonstrated that the company has a robust quality infrastructure to offer high-quality software solutions for the medical field. This certification underscores Kapelan Bio-Imaging’s commitment to continuous improvement and customer satisfaction.

“We are proud to have received the ISO 13485 certification, as this marks another milestone in our commitment to providing top-notch solutions for medical imaging,” said Olaf Brenn, CEO at Kapelan Bio-Imaging. “This certification confirms our dedication to quality and safety and gives our customers confidence that they are working with a reliable partner.”

Kapelan Bio-Imaging offers new calibration service for grayscale charts

August 29, 2023

Kapelan Bio-Imaging, a provider of innovative solutions for biomedical image analysis, proudly introduces its new grayscale chart calibration service. Customers can now have their reflected and transmitted light charts precisely calibrated to ensure optimal scanner performance. The calibration service is created as standardized procedures (SOP) that are based on the ISO 13485 quality management system. It is a cost-effective, sustainable and efficient service directly from Germany.

Calibration is performed as a factory calibration using optical densities (OD) and a high quality chart from the German Federal Office for Materials Research as a reference. Kapelan customers or third parties benefit from a simple and straightforward process. They send their chart to Kapelan Bio-Imaging for recalibration. The experienced team measures the chart, provides new calibration values and a factory calibration report. In addition, customers receive a new measurement file for optimal use of the calibrated chart.

Regular calibration ensures safety, cost effectiveness, compliance with quality standards and regulatory requirements. Financial savings through reduced product liability costs and longer instrument life are possible. Reliable calibration is an essential part of an effective quality management system and ensures precision and reliability. Especially in the highly sensitive field of medical laboratory diagnostics, consistently high quality of measurement results is essential.

 

 

New PQ Extension: Ensuring Accurate Analysis of 1D Gels through Full System Validation

April 20, 2023

The PQ Extension is an advanced software tool by Kapelan Bio-Imaging that extends the capabilities of LabImage 1D. It enables users to run a full analysis system validation for any 1D gel or western blot, providing proof of analysis quality. This is a significant breakthrough as it allows users to ensure that their analysis results are accurate and reliable.

The PQ Extension is based on a generic validation 1D gel that shows the band and lane structure with different backgrounds. This gel is scanned and analyzed with the standard LabImage 1D features. During the analysis, the measured data is compared to the given values from the validation gel. Deviations between the validation data and the first or previous validation run are recorded and reported in the validation report.

One of the primary advantages of the PQ Extension is that it is the first ever full system validation for 1D gels on the user’s side. It provides fully automated validation of the system, comparing deviations to the first and previous run. The resulting validation report is Part 11 compliant and provides users with peace of mind that their analysis results are accurate and reliable.

Read more on the new extension PQ 

ISO 13485 certification successfully confirmed

March 16, 2023

Kapelan Bio-Imaging has successfully passed the ISO 13485 audit for medical devices

After the initial audit of the quality management system according to ISO 13485 in March 2022, Kapelan Bio-Imaging has now successfully passed the surveillance audit. Kapelan Bio-Imaging is therefore still a certified provider of medical products according to ISO 13485. In addition to conformity for medical products, the area of IVD (in vitro diagnostics) is an important segment for Kapelan. “The constant further development of our quality guidelines according to the quality management system leads not only to an increase in the quality of our software but also to better transparency for our customers,” explains Olaf Brenn, Managing Director of Kapelan Bio-Imaging GmbH from Leipzig.

A fully automated system qualification for analysis of gels and blots

October 6, 2022

Kapelan Bio-Imaging works on a module to run complete system validation (PQ) for analysis software LabImage 1D

As analyses become more and more complex, and are increasingly automated while at the same time having to comply with the highest international standards, the requirements for system validation are also becoming ever greater. For this reason, Kapelan Bio-Imaging has been working hard to provide documented proof that their laboratory diagnostics software reliably meets all regulatory requirements, both now and in the future. This proof serves to ensure that the programs, as installed and operated at the customer’s site, permanently comply with the predetermined criteria and that the results obtained reliably meet their specifications. To achieve this, in addition to the mandatory Installation Qualification (IQ) and Operational Qualification (OQ), Performance Qualification (PQ) must be applied to transfer the customer’s processes to the software or to set up the software for use with the customer’s processes. Kapelan Bio-Imaging stands for consistently high quality measurement results and reliable laboratory diagnostics at the highest level and would like to prove this in a transparent manner.

For this reason, Kapelan Bio-Imaging has already been working on the realization of an extension for LabImage 1D. LabImage 1D is a flexible software solution for the partially automated analysis of 1D gels and Western blots. Using a generic 1D gel, it should be possible to check the evaluation process fully automatically by comparing the target and actual values. This special generic calibration gel shows clearly defined bands of different intensity on traces with graded background coloration. The values of these bands are determined by measuring the optical density (OD). These values are then compared with the determined actual values to confirm the analytical performance. Particularly practical at this point is the use of a transmitted light scanner, which can be combined with the LabImage software and controlled directly from it via Scan Interface. With this extension, it will be possible for the first time to carry out a complete evaluation process from scanning, calibration to evaluation on a customer-side installation.

Certificate for ISO 13485 granted

June 6, 2022

Kapelan Bio-Imaging is certified supplier according to ISO 13485 for medical devices

After successfully completing all inspections, Kapelan Bio-Imaging received the ISO 13485 certificate by beginning of June 2022. From now on, the developer and distributor of software solutions for digital image analysis in laboratory diagnostics demonstrably complies with the highest international standards in this sector. The fulfillment of these requirements is essential in order to be able to maintain its position on the international stage of scientific and medical research, clinical laboratory routine and the pharmaceutical industry. The certificate guarantees an optimal flow of all processes from software development to testing and release up to maintenance. Furthermore it ensures the highest possible transparency. The certification audit was already completed at the beginning of March 2022. The complete process from the beginning of the implementation of the new quality management system to the certificate took about 16 months. During this period, the existing processes, which were already running with above-average transparency and validity, were further optimized and improvements were stringently implemented so that they now demonstrably and comprehensively meet all requirements of ISO 13485.

Download PDF with certificate for ISO 13485 

Quality management system for ISO 13485 fully implemented according to the latest standards in software development

April 26, 2022

Kapelan Bio-Imaging GmbH is a developer and distributor of software solutions for digital image analysis in laboratory diagnostics based in Leipzig, Germany. The software is used in scientific and medical research as well as in clinical laboratory routine or in the pharmaceutical industry and is marketed worldwide. However, increasingly complex global networking of different players in the laboratory routine inevitably leads to increased requirements for internationally valid certifications for companies in this industry. The processes of laboratory diagnostics must not only be of high quality, but above all must comply with globally valid standards in order to be equally transparent and reproducible. To ensure that Kapelan Bio-Imaging can demonstrably meet these requirements, the company has been working on the implementation of the new quality management system (QMS) since February 2021. It was successfully implemented in the same year, enabling the company to start working with the new QMS in November 2021. The focus of this system is to increase the quality of the software produced by Kapelan Bio-Imaging. It is achieved through a wide range of measures, from software development optimization to testing, release and maintenance. Although these processes have already been implemented to a large extent in line with the requirements of ISO 13485, this implementation is now being carried out much more stringently as part of the company’s own quality management system. In the course of an audit, a customer from the regulated pharmaceutical environment noted that the processes had already been running transparently and validly to date and that they largely met the requirements of ISO 13485. Nevertheless, official verification is essential in order to meet the requirements of Kapelan Bio-Imaging’s target markets. On march 9th 2022, the certification audit was successfully completed in this regard.
The ISO 13485 certification provides Kapelan Bio-Imaging with definitive proof that all processes and products meet the current international standards for medical devices in terms of quality. In addition, CEO Olaf Brenn sees an opportunity to expand the company’s reach through this proof. “We are pleased with the successful completion of the certification audit. As a result, we see ourselves in a good position to develop new target groups.”

Professional metadata management with new LabImage 1D Metadata Extension

February 2, 2022

 

With the new Metadata Extension, Kapelan Bio-Imaging provides an extension for the world-wide established LabImage 1D, which simplifies the input and handling of additional data (metadata). Users are enabled to quickly and efficiently store metadata for their 1D imaging analysis and use it for later searches. The cumbersome paper-based recording of experimental conditions, annotations, comparative evaluation, etc. will, thus, be outpaced. In particular, companies and institutes involved in drug development or drug screening are offered a flexible option for annotating and evaluating metadata in 1D imaging analyses that is compatible with established solutions.

Among others, the LabImage 1D Metadata Extension provides its users with the following features:

  • Individual data hierarchisation: The user himself determines the annotation levels at which metadata are added to the 1D imaging analysis. For example, this can be done with reference to an ROI, individual tracks or bands.
  • Diverse data types for annotation: The extension allows its users to assign text (strings), integers and decimal numbers, a yes/no selection via the checkbox as well as data specifications via selection lists, which can be individually adapted to the respective user needs. In addition, value ranges can be stored for the selection of decimal and integer numbers per field.
  • Search function for metadata aggregation and evaluation: Metadata is entered at various hierarchical levels via data tables, ensuring the validity of the entries directly upon annotation. The Metadata Extension also provides users with a search option based on the entered data, which can be saved and is thus immediately available for further use and evaluation. In this way, the search results can be transferred to other apps or extensions with just a few clicks. For example, they can serve as the basis for graphical representation in the form of a dendrogram.

Thus, the LabImage 1D Metadata Extension is a flexible solution for specifying metadata and assigning them to objects. The metadata is managed via the intuitive and storable search function, which also enables the subsequent aggregation and transfer of the results to another extension. The extension also fulfils all requirements of FDA 21 CFR Part 11 compliance, so that data integrity and traceability can be guaranteed at any time of evaluation. Make your metadata management more efficient with LabImage 1D – we will be happy to support you with individual metadata solutions!

 

   

New Release 4.5 of LabImage

December 17, 2021

Kapelan publishes new software version for LabImage, Long Term Support Version, risk assessment according to ISO 13485.

With the version LabImage Core 4.5, the new release will be published right before Christmas.

Kapelan used the time to make some optimizations to the LabImage software. A large part of the work was spent in device handling and their calibration as well as adjustments to the LabImage 1D. Small improvements have also been made to simplify routine work. With the introduction of a quality management system according to ISO 13485, a risk assessment and extended release notes are available with the release. Release 4.5 is a Long Term Support Release (LTS) and is therefore fully downward compatible with all previous versions of the 4.x series. The LTS release brings some important adjustments especially for customers from the regulated environment according to FDA 21 CFR Part 11.

Statement for error in modul Log4J in LabImage

December 16, 2021

According to the assessment of the German Bundesamts für Informationssicherheit (BSI), the Java library Log4J contains critical errors that can lead to a serious threat in the area of IT security. This mainly affects server systems in which the module is used as part of the architecture. According to the BSI, only online systems can be affected. In the versions 2.0-beta9 up to and including 2.14.1 it is possible to execute remote code. Kapelan also uses the Log4J module for handling actions in 21 CFR Part 11 mode. Since the LabImage systems cannot be accessed online or via the web interface or an earlier version (less than 2.0) is used, LabImage is not affected by the error. A user must also be authenticated against the database in order to send log entries. An active reaction is therefore not required.