DATA MANAGEMENT: BIOBANKING
Thermo Scientific’s Nautilus LIMS not
only facilitates data capture and specification management, but it also facilitates chain-of- custody and handling assurance needs that improve operational efficiencies.
Tracing samples
One of the requirements of a LIMS platform for biobanking that Tom Kent, president and CEO of LIMS provider Sciformatix, identifies is to maintain a chain of custody indicating who handled the sample, what procedures were carried out and when processing occurred. Sciformatix’s SciLIMS is a software-as-a- service platform providing a flexible solution that allows organisations to tailor the storage configuration setup to their needs. FreezerPro software from US-based Ruro also allows repositories to track samples and retrieve associated metadata. The software supports high-throughput 2D barcode scanners, RFID readers and vial robots. Bill Greenhalf, operational director of the Liverpool ECMC-GCLP facility at the Royal Liverpool University Hospital, states that the LIMS software installed at the facility has two main purposes: ‘It is there firstly for quality control, but also to leave a trail to
show quality control procedures have been followed.’ The Royal Liverpool University Hospital
houses three repositories: the Liverpool tissue bank, the CLL (Chronic Lymphocytic Leukaemia) biobank and the ECMC-GCLP (Experimental Cancer Medicine Centre- Good Clinical Laboratory Practice) biobank, the latter of which stores samples from clinical trials. Each of the biorepositories uses Autoscribe’s Matrix Gemini LIMS to manage the data associated with storage of biological samples.
‘LIMS should
integrate easily with instrumentation systems’
Greenhalf notes that the LIMS enforces
the user to leave a trail and that trail defines every step of the process. He says: ‘Other users would potentially install LIMS to manage a high throughput of samples. This is certainly not the case for us. LIMS isn’t used to increase throughput, but rather to increase traceability for audits and quality control.’ There are two bodies in the UK that regulate the processes involved in sample
LABS/QM SAP Middleware bridges the Gap between SAP QM and the Laboratory Level
SAP QM
SAP ERP is used by almost all chemical, petrochemical and phar- maceutical companies world-wide. By the use of the PLM/QM module a broad variety of function- ality is achieved, which formerly was restricted to traditional LIMS in the laboratories. However,
this module provides no facilities for a direct link to the level of laboratory equipment. Therefore, this system is limited in acceptance, especially in the regulatory environment and in high-throughput analytical laboratories.
Our Experience
For more than 20 years, iCD. has been a proven supplier of multi-functional, multi-purpose LIMS solutions and other outstanding laboratory automation software tools, and is certifi ed SAP software partner since 1997. Based on our long-lasting experience in lab automation and comprehensive knowl- edge of lab requirements we have developed a unique Middleware that offers the possibility to connect any measuring device or analytical system directly to the SAP QM using standard QM-IDI/RFC or NetWeaver XI Webservice including CDIX for SAP communication.
Automated SAP Middleware Workfl ow
The information of the SAP inspection lot is directly converted by the Middleware LABS/QM to a suitable data format for analytical instruments and systems. This information can be used for generating sequences for all com- mon chromatography data systems (CDS). In addition, the derived data are suitable as sample information for a variety of further analytical instruments
storage: the Human Tissue Authority, which ensures regulations laid down by the Human Tissue Act of 2004 are followed, and the Medicines and Healthcare products Regulatory Agency (MHRA), which ensure clinical trials are conducted properly. ‘Both bodies carry out inspections; the MHRA in particular can visit the site at any time to conduct a longitudinal study of a sample, i.e. determining where the sample was at all points throughout its lifecycle and what was done with it,’ Greenhalf states. The Royal Liverpool University Hospital
has one of the largest clinical trials units in the UK, which is involved in the administration of a large number of trials. ‘There are two conflicting responsibilities,’ explains Greenhalf. ‘One is to the patient, and inspectors need to know that the participant fully consented to the study, but there is also a need to show that researchers are not influenced one way or another in showing that a particular agent or procedure is working. Therefore, it is very important that the analysts working in the labs have no idea to which participant the sample belongs.’ Biobank administrators try to keep consent forms and evidence for that consent ➤
and control software, e.g. for IC, ICP, AAS, IR, NIR, RFA, elemental analyzers and many others. Even simple laboratory devices can be connected directly to the SAP QM via the LABS/QM, e.g. analytical scales, gauges, automatic titrators or even pH meters. Also, automated result data import from any fi le type (ASCII, PDF, DOC, XLS, HTML, XML, others) as well as a workplace- specifi c data entry with full-automated instrument control and data import into the Middleware, is supported. After completing the measurement and review of the result, the results are transferred to the Middleware LABS/QM for additional calculations and conversions. Thereafter, the analytical data are transferred via the Middleware directly to the inspection lot/test unit of SAP QM, where the evaluation of the results is achieved, thus, completing the treatment of the inspection lot/test unit, and reaching the usage decision.
Your Benefi t
Qualifi ed data transfer from instruments to LABS/QM replaces the time- consuming and expensive double checks. Errors caused by manual data entry are entirely eliminated, and, in this way a GxP/FDA compliant workfl ow is achievable. In addition, the Middleware LABS/QM increases the automa- tion level in the laboratory, leading to an improved effi ciency of the employ- ees and resulting in cutting the costs of the entire laboratory and business workfl ow.
LABS/QM – SAP Middleware that brings our Experience to your Laboratory!
info@icd.eu Web: www.icd.eu, Phone: +49 2234 96634 0
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