Q1. What do I need to look out for in a LIMS (or update in my current system) when transitioning to ISO 10725:2017?
The ability to handle all aspects of ALCOA e.g. audit trail, electronic signatures, ability to store and retrieve spectral data, training records, instrument calibration and maintenance scheduling.
Q2. How can a LIMS help in proving instruments being used now and in the past are calibrated and maintained correctly?
Your LIMS should be closely linked with instrument calibration and maintenance functions. The defined maintenance and calibration schedules should be associated with the relevant instruments in the LIMS. It must be possible to flag instruments as out of service in the LIMS if they have not been maintained or calibrated in accordance with these schedules. The LIMS must also be capable of preventing results being entered from an instrument that is out of service. A complete history of the calibration and maintenance events for each instrument will be available in the LIMS, and the system will be able to inform users that an instrument is due to be calibrated or maintained at a defined time before it goes out of service. Implementing instrument calibration and maintenance functions within LIMS removes the need to manage it in a different system or through uncontrolled spreadsheets and can ensure that out of service instruments cannot be used by mistake. Being able to easily link the instruments used for testing with their calibration and maintenance history improves traceability and integrity of the data.
Q3. Should we consider closely integrating instruments to our existing LIMS? Does the cost provide sufficient benefits compared to buying a new LIMS?
In most circumstances the answer is yes. Where an instrument is handling many samples a day e.g. HPLC, results from that instruments can be in their hundreds per day. As such manually transcribing these results from the instrument to the LIMS is impractical and prone to error, typically in the order of 3 to 6 mistakes for every 1000 results when done by hand. Integrating directly to the instrument automates the upload of the results and also remove the necessity for a second set of eyes to authorise the results. This can save up to two man hours a day per instrument meaning a laboratory with just four instruments could a save an entire man day, the equivalent of a person per year.
Q4. How should we show personnel are competent to perform the work required of them and maintain their previous training records?
Training records should be part of the LIMS functionality to allow linkage between the test result and the operator. Each operator record should have a valid training certificate in the LIMS for each activity they undertake. LIMS should record when the training for any certified activity took place and its validity period. Functionality should be present in LIMS to prevent an untrained operator or an operator whose training has expired from being able to perform tests. Competency levels can be recorded against each analysis for the individual demonstrating their ability to perform tests with or without supervision.
Q5. To what extent should we be relying solely upon our LIMS to manage documentation within the laboratory?
Whatever documentation system a Lab uses it must be readily available to the staff and provide reliable repeatable results. LIMS may include a document management system to store and retrieve documentation and enable staff to sign that they have read, understood and follow the procedures within. A Laboratory Execution System (LES), which can be built into the LIMS, may be used to force staff to follow a specific operational procedure line by line. A LES can work well when tasks are very standard and repeated often. Where notes and observations are required these may be added against the sample or test results directly in the LIMS and stored with the sample information. In research and development, where experiments and variations in testing are common Electronic Laboratory Notebook (ELN) may be integrated into a LIMS to keep larger amounts of freeform notes and data within the same database.
Q6. Decision Rules are key to reporting in 2017. How can my LIMS help with this?
Advanced LIMS have workflow engines at their heart driving rule based decisions. These should be easily configured in the system via the use of graphical workflows allowing the user to build up “if that then this” based scenarios which automatically guide the user to compliance. In addition the use of such tools in LIMS as analytical quality control, enforce good practices around the calibration and recalibration of instrumentation based on statistical data.