Maintaining data integrity is obtained by using audit trails tracking of all lab activities be it experiments, sample management or instruments usage. Keeping organized records and tracking all activities makes it much easier when an audit is executed and data requested. Using a lab information management system combined with an ELN and informatics solution facilitates maintaining data integrity at the highest levels as everything is recorded and organized in the best manner possible while preventing time loss, human errors, in addition to reducing costs.
Calibration is one of the primary processes used to maintain instrument accuracy and it is crucial for generating reproducible results and maintaining data integrity.
Not calibrating your instruments properly can result in inaccurate and false results which can lead to failing FDA audits that may end up with an FDA warning letter. It is important to ensure that calibration data is not modified or backdated after it’s been recorded.
Searching through FDA warning letters issued in the past few years with regards to calibration demonstrates that failure to calibrate equipment on time and document calibration procedures are recurring issues that surface time after time. It is easy to avoid such failures and maintain data integrity and traceability simply by using a calibration management software that will enable to track equipment maintenance on a regular basis. A lab information management system that integrates calibration management is a huge advantage and saves administration time and costs resulting from having two different solutions.
Keeping track of orders manually is a sure way to be susceptible to human errors. It is most annoying to find out that a certain material is out of stock or not to be found when you are about to perform an experiment. Using an inventory notebook as part of your ELN will enable you to track your orders systematically and efficiently, eliminate duplicate orders, avoid misplacement of materials or improper sample cataloguing. Also, each action that was taken on a sample is recorded (usage, movement, etc.).
Automating processes and leaning on a lab information management system to mitigate the risk of human errors will enable your organization to focus on development, free time of your lab members and better comply with FDA regulations.
According to FDA’s Data Integrity and compliance with CGMP, it is advised to store data in a lab information management system. Each data entry should be saved separately and easily located. It is advisable to use a LIMS system with a complete audit trail to all system records-
every change to the system is immediately logged and saved. Each audit-trail entry is time-stamped – the data transfer and the user sending the request are both recorded to the system. In addition, 21CFR#11 requires a two-person signature (signature and witnessing). Once a record is signed and witnessed, Labguru will auto-generate a PDF version locking the date of the signature and all associated assets with that signature.
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