apislabor.at

blog

Themen, die uns beschäftigen:

Paperless lab – smart into the future

digitalization is a must have in the pharmaceutical area

digitalization is a must have in the pharmaceutical area

1965 Gordon Moore predicted in the article - Cramming More Component onto Integrated Circuits - in the magazine Electronics, that digitalization will double every year (at least until 1975) and in fact the law is still true in 2018.  We have reached a point where data need to be immediately accessible. Not only the traceability of results also the readout of all the raw data is getting more and more into the focus of interest. The Good manufacturing Process requires full traceability through every manufacturing and control step and Auditors from Health authorities are expecting reliable data.

Nonetheless, industries are not uniformly adopting laboratory informatics. Although agencies such as the Food and Drug Administration encourage electronic documentation, Experts from the industry say, "The pharmaceutical industry is generally conservative, and it's often easier and cheaper to stay with a paper system that is known to be accepted by regulatory agencies." In fact, requirements of Health Agencies have dramatically changed over the last years and the expectation on data integrity cannot be fulfilled with a paper based system.  

LIMS is more than just an archiving database for specification and results. It has to be the leading system in the labs, responsible for the entire laboratory processes, from sample management up to version-controlled testing procedures and lab organization within the system, to an integrated laboratory execution System (LES).

A strong focus should also be put on the interfaces, especially CDS. Any compromise or offline data leads to more bureaucracy, data integrity lacks and complex work around systems. A hybrid system, where not all instruments are fully integrated with LIMS, is very often a bad compromise at the expense of efficiency and costs.

This tendency is true for big and small enterprises. Especially small labs in the founding stage are facing limited financial resources due to high costs in lab building, investment in the basic set up of instruments, personal costs and IT infrastructure. On top of this costs, a standard enterprise LIMS System including implementation costs can reach up to 300k€ which at the end might be a show stopper for the digitalization in the founding stage. A competent partner and a fully functional LIMS, which can be configured in house, is crucial to be successful in meeting the requirements of agencies and customers.

A conclusive business concept from up to data enables small and medium-sized laboratories to implement a LIMS system with little effort. Based on Sample Manger Lims, up2lims was adapted to meet our requirements with configuration only.

Preconfigured templates and the use of an efficient „Coaching“ approach for Implementation guarantee a rapid Implementation and reduce the total cost of ownership by imparting detailed system knowledge which can be used for future modifications.

Digitalization isn´t any more a vision for the future, but takes place right now. It is a major driver of future competitiveness and innovation and should be seen as an opportunity, especially for small labs.