Laboratories are coming under increasing pressure to satisfy various regulatory and laboratory certification requirements. Whether or not a company’s laboratory can boast ISO certification, for example, will often determine the company’s success in international markets.
For the highly regulated industries the stakes can be even higher. The American Food and Drug Administration (FDA) has the power to fine a company or even to close the business down if it fails to comply with the regulations, many of which are the laboratory’s responsibility. One large drug company, for example, was fined US$500million by the FDA for violating current Good Manufacturing Practice (GMP) regulations.
For companies less stringently regulated than by the FDA, laboratory information management systems (LIMS) still provide benefits through improved quality of data, faster turnaround of more accurate data, automatic generation of exception reports and CoAs. Being able to disseminate this new found quality data to management for faster decision making and with the ability to dynamically update manufacturing systems and remove potential areas for errors will provide tangible benefits that can be measured. Saving time in correlating results to samples, etc, is just one example.
More importantly, to some organisations, is the demand to provide information to customers using the internet or intranet. Customers can log in using a web browser to access their data in the LIMS as a qualified user. This access can allow samples to be logged in, reports generated, etc. or just to review what is current. Another alternative is to access a web site that is dynamically updated by the LIMS on a defined time frame.
So, as well as striving to produce the best results possible from a technical point of view, laboratories are also bound to operate to satisfy the legal and commercial aspects of their operation. While these requirements are not contradictory, they do have different purposes and emphases.
One thing they do have in common, however, is the need for accurate and complete documentation. Traditionally, of course, paper has been the most used medium for this documentation, but this is now being rapidly overtaken by the use of computerised records, both because of the major increase in efficiency provided, but also because the technology produces a more secure form of storage and a better base for making use of that data. LIMS are including Document Management functionality now including version control and approval routing.
The volume of data generated in this endeavour and the complexity of the statistical calculations required advocates the use of computerised systems to manage all the necessary information and processes.
LIMS is centric to a wide range of companies in ensuring that whatever your product is, whether something manufactured or in the form of information that you are providing/selling to your customers, is produced effectively and is in specification. LIMS will help in reducing the time to get your products to market by providing the best information quickly, in an easy to assimilate form that is accurate and meets your regulators and customers’ demands for now and in the future.
Mike Hatton is with LabWare Ltd, Knutsford, UK. www.labware.com
