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Improving Data Integrity in Laboratories with a Customized Laboratory Information System

Data IntegrityAlmost all sectors of an economy are in the process of digitization with the support of data entry services as it reduces cost, time, labour and potential error and prevents loss of data that can be caused due manual data entry and data transfer. In a laboratory setting for instance, data integrity must be ensured to prevent associated risks. Regulatory agencies consider electronic data to be more secure and less likely to be manipulated. However, even electronic data can have issues. Among the common errors labs make with electronic data are the following.

  • Lack of permissions
  • Access control errors
  • No electronic signatures
  • No audit trails
  • No backup or improper backup
  • No disaster recovery measures.

Increasing Digitization Drive in Laboratories

Many labs have turned towards digitization with Laboratory Information System (LIMS) and Electronic Lab Notebook (ELN) to replace manual workflow and aggregate data from wide range of analytical tests and to automate documents. These allow lab instruments to be connected facilitating electronic data collection. Moreover, there are the additional advantages of eliminating costs in terms of labor, time and effort associated with manual data transfer. Even so, many laboratory systems and instruments remain unconnected, and data entry and transfer is still by and large handled manually. As a result,

  • Laboratory users cannot give full focus to their science.
  • The data transcribed may be incomplete and also lack the traceability required to meet internal QA and regulatory mandates.
  • There is considerable loss of revenue and time. Missing data will have to be found, results re-transcribed, reports prepared and missing controls documented.
  • For each analysis lab staff may have to comply with SOP or standard operating procedures, apart from documenting the entire process.

The problem with electronic lab systems is that they are mainly designed to collect results from a range of analytical tests. They are not designed to automate and document bench-top workflows or produce traceability information. So what is the ideal solution? The ideal and convenient solution is one that can drive the workflow SOP directly through the instrument or balance thereby producing automatic, integrated data capture and instrument management. This allows lab personnel to focus on the analysis. This single-system solution is cost-effective and is a great option for managing instruments. It can be integrated with a laboratory’s LIMS or ELN.

In such a system, the balance or instrument touch screen provides real-time, detailed guidance to the user. Errors associated with manual data entry and routine performance of SOPs are eliminated. The reports generated are directly delivered to the LIS or lab informatics system. Alternately, the data can be transferred to an open Excel cursor or exported as a .csv or XML file. All information is made immediately available for analysis. Data exchange with other software systems, mobile devices and instruments is possible.

A Quick and Easy Process

The user selects a process and logs onto the system at the instrument touch screen. The advantage is that there is no need to log onto separate workstations to access each instrument. All actions made and results are recorded in the database against the user’s identity, using a time and date stamp. If a label is needed for the sample in process containing the essential quality or regulatory information (concentration, identity and expiry date), it can be obtained from an attached printer. If the system is enabled for an attached barcode reader, the entire system becomes simpler.

A customized lab information system can ensure integrity of lab data, make lab processes simple, improve efficiency and ensure traceability. As providers of data entry services including medical data entry would fully endorse, labs should be able to take full advantage of the instrument technology available.

About Rajeev R

Rajeev R

Manages the day-to-day operations of MOS from NY. With an interest in information technology, Rajeev has guided MOS to extensive use of digital technology and the internet that benefits MOS as well as MOS clients.