Simplifying Analytical Method Validation

Siemens Healthcare

We use Abacus for the statistical analysis of internal data as well as customer data. In addition to the simple, intuitive operation, the program impresses with a wealth of evaluations that cover many things that can occur in everyday laboratory work. National (RiliBÄK) and international guidelines (CLSI) are also taken into account. A great advantage, not only for accredited and internationally active laboratories. The package is rounded off by an extensive help function that we use, for example, in the preparation of method validations. Conclusion: a statistical program from practice for practice.

Andreas Ullrich, Support Manager

Salzburg State Clinics (SALK)

Our institute acquired the Abacus software as part of the ISO 15189 accreditation. The aim was to be able to compare devices and methods, determine target values, analyzes in the context of method validation (precision in series, stability, linearity, etc.) or even determine reference values, on the one hand standardized, but also to be able to calculate as easily as possible in accordance with the applicable guidelines. The Abacus software helped us tremendously and today we don't know what we would do without it.

OA Dr. Janne Cadamuro, 1st OA University Institute for Medical-Chemical Laboratory Diagnostics

Onkoberlin (Prof. Dr. med. Andreas Josting)

After a short introduction, we were immediately familiar with the program. Simple operation with initially small hurdles on our part, which, however, could be dealt with immediately thanks to the competent and fast support. The connection to our PVS also went smoothly. The graphics according to RiliBÄk were more than sufficient for the calibration office and their regular checking. With this program you can even make friends with Excel :).

The morning quality control is now faster than before and new employees can quickly settle in.

Lars Leschkowski, nurse / medical assistant

Screening-Labor Hannover

In our laboratory, extensive measures for the establishment, validation and quality assurance of parameters from dried blood and other materials are required at all times. We have decided to use the Abacus software for this. It combines all the functions that are important to us and leads to very clear logs that are helpful for quality assurance and in the context of accreditations. The software is intuitive and easy to use with a short training period. The implementation in Excel makes the transfer of data from other tables easy. The method and batch comparison can also be carried out and documented quickly and conveniently. The implementation of the requirements according to RiliBÄK, DAkkS conformity, CLSI and DIN is very useful for our laboratory.

Dr. with. Dr. rer. night. Nils Janzen

MEDIWISS Analytic GmbH

We have been using Abacus for our method validation for several years and appreciate the ease of use, the existing validation, which runs as an add-in in the familiar Excel environment without any problems. The program is of great help in preparing for the IVDR and calculating the necessary parameters. Abacus offers a variety of statistical methods and takes into account national and international guidelines (e.g. RiliBÄK, ISO 15185 and CLSI). Another plus point is that Abacus has been validated according to GAMP-5. We can fully recommend Abacus and look forward to the update.

Peer von Wahl, Bio.Sc., CEO

Provincial government health department of Lower Austria

Since my specialist training at the Univ. Klink Graz in the field of clinical chemical laboratory diagnostics I like to use the Abacus tool again and again. It is unsurpassed in its class, in particular its ease of use and clarity make it extremely suitable and recommended for everyday use. Of course, there are much more extensive and powerful programs, but some of them require a long training period at much higher costs. From my point of view, I can recommend the tool to anyone who wants or has to deal with medical statistics, especially in the area of chemical clinical issues. As an emergency doctor at the Graz clinic for many years, I can think of an apt comparison. Not every patient who calls an emergency doctor needs a general anesthetic on site, usually does it less, and the statistics programs are similar.

Dr. Gerhard Höbarth, medical officer

Bioscientia Institute for Medical Diagnostics GmbH

We have been using Abacus for several years at all of our laboratory network locations. The software is easy to use due to its integration into the familiar Excel environment, so that usually only a short training period is necessary, even for statistically less experienced staff. The range of test protocols and statistical functions included, together with the validation of the program according to the current GAMP-5 guidelines, enables almost unlimited use in all departments, including our department for clinical studies. In addition, there is the standardized output of the graphical and tabular evaluations in report form, which have so far been accepted by all testing bodies for internal and external audits (DAkkS, calibration office, sponsors of clinical trials). By using the software, we were not only able to save a considerable amount of time, but also implemented a standardized procedure for method validation and various internal quality control processes throughout the association. In view of our consistently positive experiences, we can unreservedly recommend the use of Abacus.

PD Dr. med. Markus Nauck, managing director and senior doctor

MVZ Labor Limbach Hannover

Simple and understandable application, clear "short operating instructions". A very user-friendly software solution, also for those "not familiar with Excel", since a lot is self-explanatory and the calculation can be evaluated with a minimum of time with simple clicks and given, but also changeable settings. The evaluations were accepted both in the internal audit and in the accreditation (DAkks) and during an inspection by the trade supervisory authority (the SOP documents still have to be maintained for the accreditation, but with significantly less effort). Abacus offers a wide range of evaluation options (quantitative / RiliBÄK-required + analog, as well as qualitative) so that it can be used for all of our analyzes, including good statistics and the option to enter comments. A time saving of at least 70% compared to the "earlier evaluation" here in-house, especially uniform for all departments that use it.

Marlies Bode & Uta Zinngrebe (MTAs)

Städtisches Klinikum Braunschweig gGmbH

For our laboratory, Abacus has become an indispensable and indispensable tool, primarily for comparing methods and devices. The diverse evaluation options not only meet the requirements of the RiliBÄK, but also the special wishes and requirements of individual senders such as transfusion medicine in an excellent way. The various test options are easy to find and select in the program, the menu navigation is almost suggestive. This intuitive operation is not offered by many programs today; rather, there are regularly (unnecessarily) high hurdles, especially for beginners. It would be nice if other software solutions in the laboratory were based on this exemplary structure from the Abacus Add-Inn. In addition, the use of the software allows the user to learn almost by himself. How nice if classic training software could also claim this!

Prof. Dr. Oliver Selberg, Ltd. Senior Physician, Institute for Microbiology, Immunology and Hospital Hygiene

Transplant Center Cologne-Merheim

The Transplant Center Cologne has been using the Excel add-in routinely successfully for years. We also use the program for quality assurance in our special nephrological laboratory when evaluating and recording legally binding control criteria. In addition, the program provides numerous statistical tests with which we work on scientific questions and validate new methods. The clear arrangement of the individual program elements with integrated, detailed instructions allows intuitive operation at a fair price. We also appreciate the continuous development of the program, whereby your own solution approaches can also be integrated into the program. In summary, the program is a valuable aid that we no longer want to be without.

OA Dr. med. Wolfgang Arns, Head of the Transplant Center