Living a healthy and balanced live in today’s world is becoming more of a challenge. The human nature for growth, success, and profit don’t always go hand-in-hand with a sustainable eco-friendly environment. The latest industrial revolution has left traces from which the world has yet to recover. In the end, it is the air we breathe, the water we drink, and the food we eat that makes up the environment we live in.
It is therefore paramount to provide safeguards against the deterioration of water, mitigate air pollution, and setup prevention of natural resource depletion. Governments and international organizations have already set up policies, regulations, and guidelines in order to achieve more control of pollution and protect the health of the general population. These regulations have set certain baseline standards but tend to become more strict as research discovers more distinct safety levels.
Measuring is Knowing
In order to comply with these strict regulations, companies must provide proof that certain key indicators regarding their research or production process remain within determined boundaries or specifications. If one wants to compare the presence of a certain compound, it needs to be measured to provide empirical evidence: Measuring is knowing. In more complex terms this is often described as Quality Assurance (QA) and Quality Control (QC). QA focuses on the quality when developing a process to obtain results for the key indicators, whereas QC monitors and controls results that are produced by the process; for instance, marking the accuracy, consistency, and precision by which results were obtained.
Measuring these key indicators such as metals in waste water, toxins in food, or the desired concentration in a product is commonly performed in an analytical service lab.
A typical analytical laboratory workflow looks like this:
- Gather requests for analysis from external parties.
- Receive samples in the lab and schedule the analysis.
- Execute laboratory experiments to obtain results.
- Validate obtained results.
- Release results to requestor in form of a report, i.e. a certificate of analysis.
Such a laboratory could operate with a basic set of resources:
- Trained laboratory staff: lab technician, lab manager, and scientist
- Equipment to handle and analyze samples: instruments, balances, meters, etc.
- Reagents and consumables: chemical acids, pipettes, glassware, etc.
- Knowledge base: Standard Operation Procedures (SOPs)
However, if the lab wants to optimize its efficiency, ensure quality, and comply with necessary standards in order to provide its analysis as a service, using a LIMS & ELN software solution is indispensable.
The Future Lab
Using only a paper trail to track incoming requests or calculating results in a lab notebook increases the potential risk of human error. The recent expansion of IoT devices and technology allows LIMS vendors to model a complete laboratory workflow with increased efficiency and reduced possibility of human error.
In future labs, all necessary data is entered into a LIMS in a structured way when a requested analysis is started, and AI algorithms provide efficient worklists for batch analysis by a lab technician. When an analysis is performed, a set of verification rules are automatically applied to the measured results and promptly presented to the lab validator for approval. Anytime an instrument requires calibration or maintenance, the service engineer is automatically and quickly notified by the system. When the stock of reagents are about to deplete or expire, the LIMS orders a new lot in order to prevent stoppages in the workflow. Technologies such as blockchain or a Trusted Third Party acting as a Time Stamping Authority partake to seal the experiment for IP protection once an experiment is completed.
For QA/QC, the laboratory uses various standards such as ISO9001, ISO15189, ISO17025, 21 CFR part 11, HIPAA or CLIA that are necessary to comply with required regulations. A LIMS that tracks a sample from request to validated result and offers a set of functionalities which allows a laboratory to facilitate the incorporation of the complete analytical laboratory workflow with the necessary compliance comes a long way to fulfilling the highest industry standards.
Some key LIMS features that pave the path to compliance are:
- Full audit trail of anything that happened to any sample and who made the changes.
- Ability to set up different permission roles for lab technicians, data validators, and managers.
- Track QC samples and monitor deviation and trend.
- An electronic sign-off step at the end of experiments.
More information about SLIMS and its compliance features for analytical laboratories is available from the following link: here