GEFAT-IT develops highly flexible sample management systems for a variety of applications and industries. Material/sample collections have become indispensable in the daily use of medical professionals, pharmacists, scientists and quality assurance in production. Materials, specimen and sample collections sprout up, like crocuses in spring. Sample collections are to be set up and mapped with powerful software systems that collect all the accumulated data, interact with robots and enable sample and data management.Available IT solutions and storage options provide quick entry points to start a sample collection. However, one quickly realizes that standard solutions for the needs of the individual sample collection soon reach their limits. The lowest common denominator in sample collection is that samples and data are collected and managed. The nature of the samples and the associated data are as individual as any collection itself. Also, the processes of sample collection, the sample receipt as well as their processing and publication often differ greatly.Here, finding a supportive software solution that allows a high level of flexibility to be prepared for future needs while also providing a cost framework that takes into account the individual possibilities is the goal of many users. eBioControl® supports you in all these tasks.
But are not all sample collections in the same industry, with the same focus, somehow the same?
This simple question conceals a high degree of complexity at first glance. If you build up a collection of material for quality assurance purposes for the production or collect medical samples, nobody will suspect a parallelism here and look for the same product.
But also different biobanks, which collect all blood samples from patients, differ strongly. Some build a biobank purely for research purposes, others as a supplement to your sample collections for diagnostics in patient care. Others collect urine, sputum, tissue for study purposes.
The different objectives of the individual sample collections not only lead to different requirements for systems supporting them, but also to a different legal view of the materials. This must be reflected both in the handling of the samples and in the data management. So far, data has been collected according to the principle "a lot helps a lot". This led partly to a confusing and poorly structured Datenwust. Not to mention the materials / samples, about whose origin and life path little secure information was available. Only the samples and materials as such slumbered in different cooling and storage systems. To manage the collective lust required not only large storage capacities for the samples, but also immense storage capacity of computers for the unstructured data storage and security. This inevitably led to an approach that states that one collects "as much as necessary and as little as possible" in terms of data. Only evaluable data of a defined quality make samples what they represent for the collection of samples - the heart.
eBioControl® - flexibility and safety
In order to map the diversity of materials, samples and specimens with their divergent data, GEFAT-IT has developed a highly flexible software eBioControl®. Based on many years of experience and successful collaboration with doctors, scientists and computer scientists, this solution has been developed according to the latest technology. An intuitive interface allows quick familiarization and clear access to the various data. Just as helpful is the fact that the interface is based on user rights. Thus, each user only gets access to the relevant functions and information.
Store samples clearly
eBioControl® maps storage structures both graphically and in a tree structure. Thus, the depots can be displayed from various locations, storage rooms, refrigerators, nitrogen tanks to individual items in a box. The created depot structure can be arbitrarily branched and extended.
Since cooperations, different locations, interdepartmental work play an increasingly important role, different institutions can also use a common system to map their storage structures. An institutional view of the data is crucial. Institute 1 does not want and may not move refrigerators in the institute or create new nitrogen tanks. On the other hand, a sample shipment between the two institutes can be comfortably displayed and documented, using a common system, such as eBioControl®. Collaboration is thus easily and safely possible without having to commit institutions to a common structure of their storage capacities.
Colored markers and clear displays of samples in a box make the job easier. Injections, transfers and transfers of samples can be carried out individually, in batch, semi-automated or fully automated. Rearrangements of boxes, racks or even entire refrigerators can be carried out easily and quickly using drag-and-drop.
The optimal utilization of storage capacities is also supported by eBioControl®. Thus, a maximum filling of boxes can be achieved after the user has searched for free storage bins and received suggestions. The resulting densification of samples can be implemented manually as well as by rack scanners or robots. The documentation of these processes takes place automatically in the Audit Trail and Tracking module.
Store samples, manage storage capacities are basic functionalities of storage software. However, it becomes exciting when a wide variety of sample collectives are created and the associated data are to be used in different ways. The variety of possible requirements is unlimited. At this point, the philosophies of the manufacturers of sample management software systems separate.
Create input masks yourself
The collection of sample / materials, as well as subject / patient / donor / recipient data provides a broad field of creativity. Solutions that are prepared for unknown future requirements can be found only a few. Many manufacturers specialize in individual areas of expertise because of their complexity. Thus, in the manufacturing and research industries, universities, university clinics and other institutions, there are a multitude of different software solutions that deal with samples and related data. But each system is used only within its specialization, because only here the subject-specific software requirements have been implemented.
With eBioControl® we have developed a concept that enables all customers to create their own input masks, so-called categories. Here users can create their own input masks for any sample information for the various material groups, studies, projects without having IT skills. The data type security remains guaranteed. The user may be selected from a variety of data field types, such as Select date, text, number, decimal, note, color, signature and many more. These data field types can be named according to their own ideas and linked with parameters such as uniqueness, field length, obligatory (yes / no) etc. The input mask (category) created in this way is not only available for data entry and editing, but also for searching.
Find samples and information
Storing samples and entering data does not pose any great challenges. It will be interesting to create sample collectives and pick the samples. The criteria for the composition of the samples are as varied as the sample data itself. Thus, the possibility of using all sample information, which has been recorded by the software, makes sense. The combination of sample data by means of an AND or OR combination offers maximum flexibility for assembling sample collectives according to various parameters. Thus, e.g. Blood samples for patient data, blood type, date, Rhesus factor (category A), etc., will be searched, so that all samples from a patient containing blood type A are displayed. But it can also be searched for all samples containing a specific date AND the blood group A. Here you would get a subset of the first search. If one chooses an OR operation, e.g. specific date OR blood group A would be expected to have a larger sample size.
Thus, the data fields from the respective datasets can be combined as desired and thus optimally used for the processing or evaluation of research topics.
The search function in eBioControl® can therefore not only use all data for the sample compilation; these can also be further specified by means of an AND or OR operation. Filtering and sorting functions in the search result enable a clear overview even with large result sets.
Collect and manage sample data
Collecting sample data is one of the most important tasks of material collections besides storage. However, just as sample collection is often done by certain individuals, sample data collection is often tied to individuals with specific rights. Precisely in the regulated area, the balancing act between the assignment of samples to the donor / patient / subject must be guaranteed and, at the same time, a pseudonymisation succeed. This requires a sophisticated rights and roles system. For example, in some biobanks, the sample registration may have to be performed by different people, but the subsequent entry of sample data may only be carried out by particularly authorized persons. It may be that a group of users may and must work with personal data (e.g., patient, subject, donor data) while other users may use only a pseudonym of those samples for the same samples. Or only a specific employee is allowed to release samples of a batch / batch / LOT, change the quarantine or release status.
Rights and roles that define the view of data, their processing and their use for the respective user can be defined in eBioControl®. This creates security when dealing with the system and allows a large group of people, their individual use.
The 3 big W's
Who has what When done, these are the big 3 W`s. These play an important role in all regulated areas, but also more and more in unregulated areas. The documentation of these 3 large W's provide the basis for security and traceability of processes as well as the complete traceability of samples. For quality assurance and for the approval of such a system in regulated areas, eBioControl® reliably records all changes to the system. Sample and depot movements, changes to sample information, sample shipment, etc. are automatically documented.
Filtering functions allow the search for certain events, changes, or e.g. People who made these changes. Thus, at any time, past events can be safely and easily recapitulated.
Communication with the laboratory environment - interfaces
But no system in our digitalized world is independent of the existing IT-specific infrastructure of the respective institution. Whether it's the connection to label printers such as Zebra, Brady, barcode scanners from Thermo Fisher, Micronic, FluidX, Ziath, hospital or ERP systems such as SAP, Siemens - interfaces enable communication.
The use of standardized and also customer-specific interfaces thus form the connection of all required information, regardless of which manufacturer and which devices. The integration of devices and external data systems prevents double entries and redundancies. This leads to optimal data security, the reduction of costs by the provision of already existing data and also support of the work processes within a material bank.