Organizations need to ensure that they meet the various regulations placed on them, depending on both the domain and location they operate in. These regulations can range from ensuring that data integrity is maintained, like the good practice regulations, through to ensuring that work performed in the laboratory is conducted in a safe manner. With so many regulations to follow, and so many agencies involved in ensuring that these regulations are followed, it is important that organizations can capture any necessary data and report on it efficiently.
For organizations operating globally, complying with a variety of regulations and agencies can lead to a wide range of reports, for a wide range of data, all in different formats. The end result? Laboratories are spending huge amounts of time and money creating and maintaining health and safety data. To help, they are looking for solutions that can proactively manage the safety data within their organizations with minimal impact and reduced cost.
It’s easy to see why organizations are so keen to use software in their labs: the ability to automate the capture of data can make information more transparent, meaning it can be efficiently reported on and faster decisions can be made, ultimately reducing time and cost. So, what solutions are being considered?
Increasingly, organizations are looking at electronic systems such as laboratory information management systems (LIMSs) and electronic laboratory notebooks (ELNs) to manage and monitor their safety data. For many laboratories, this is a natural progression in their use of electronic systems. Historically, the management of experimental data and safety information has been a paper-based process, so as they turn to using software to manage their experimental data, it also makes sense to use software to manage their safety data as well. Ideally, organizations are looking for solutions that can meet both their experimental data and safety needs all in one piece of software.
Software systems, such as ELNs and LIMSs, can be configured so they are aware of the standard operating procedures (SOPs) and safety controls used within a laboratory/organization—either by having the appropriate data for the workflows being performed within the system or through queries from an external database, such as when personal protective equipment must be used or when the use of a potentially harmful substance, such as an amount of a flammable solvent in a chemical reaction, has exceeded the accepted “safe” limit.
Most LIMSs and ELNs allow the configuration of the behavior when safety controls are exceeded so that organizational controls are met. Users performing experiments can receive warnings if a safety control limit has been exceeded, with manager/safety officer approval needed in order to continue with the workflow. In addition, events can be flagged to any required person within an organization so that further investigation can be performed and any appropriate approval is obtained— ensuring that safety practices are followed, documented, and meet any legal requirements. In many cases, the capture of safety information can occur in these software systems either automatically or as part of the experimental workflow, helping organizations maintain an efficient process and facilitating compliance.
By capturing safety data in a software system, such as an ELN or a LIMS, you can report on data both in a proactive and a reactive manner. This is a clear advantage over older paper-based processes, which tend to be used only reactively—when a “safety” event requires historic data to be reviewed and analyzed, looking through paper records can be extremely laborious and time consuming.
The reports generated by ELNs and LIMSs can be used in several ways to improve safety and reduce costs. Reporting can show whether there are patterns of safety controls being used or exceeded within a laboratory, which may highlight that a laboratory needs training or an experiment SOP/workflow needs reviewing to see whether it can be improved, so that fewer safety controls are exceeded.
Most laboratories will have instruments that require servicing and calibration, some of which will also have safe operating limits. In a similar way as described above, ELNs and LIMSs can be used to capture details around both these events and any controls in place. The stored information can then be easily used in subsequent operations, for example, to report on instrument usage and to confirm whether safe operational limits are being maintained.
Electronic data management systems can also help when reporting on the use and disposal of controlled substances. In many jurisdictions, organizations need to report, to the appropriate authorities, on the amount of controlled substances used and disposed of in a safe manner. Since the usage information is generally captured as part of a workflow, creating this type of report in an ELN or a LIMS is straightforward and requires minimal effort.
Laboratories generate huge amounts of information, ranging from experiment data to the safety data that’s required to be kept by regulatory authorities to confirm whether workflows and operations are being performed appropriately. Software solutions, like ELNs and LIMSs, enable organizations to be more transparent about the activities that are being performed—but they also provide a number of benefits, including better communication of information, a common way of capturing and reporting data, avoiding duplication of effort, and enabling faster decision making.
Most organizations are aware of these benefits in the context of their scientific research and development, but with some small changes to workflows and practices, the same information can be used to make their laboratories even safer and more efficient—which ultimately can lead to cost savings as scientists spend less time on reporting on regulatory or safety data and more time on valuable research and development.