Automating Data Management while Facilitating Regulatory Compliance
Nova Biologicals implements an integrated water, environmental and pharma LIMS/DMS
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Nova Biologicals is a full-service, National Environmental Laboratory Accreditation Conference (NELAC)-accredited laboratory in Texas, providing testing and consulting services to the water, medical device, pharmaceutical, nutraceutical and food industries globally. Water testing makes up 53 percent of Nova’s total revenue, and the laboratory specializes in microbiological, chemical and toxicological testing of drinking water and wastewater samples. A team of dedicated scientists provides comprehensive diagnostic testing of specimens for the presence of infectious disease organisms and water testing under the Federal Safe Drinking Water Act.
With approximately 10,000 water samples being processed on a monthly basis, coliform bacteria testing makes up the largest percentage of tests performed by Nova. While not all coliforms are harmful, the presence of coliform bacteria in drinking water indicates that other disease-causing organisms also may be present in the water, making it potentially unsafe to drink.
The challenge
Nova, like all organizations involved in water and environmental processing in Texas, must comply with stringent quality requirements introduced via the U.S. National Environmental Laboratory Accreditation Program (NELAP) and the U.S. Environmental Protection Agency (EPA). The regulations provide a set of protocols outlining what is acceptable regarding the daily processes within a multi-disciplinary water laboratory in accordance with internationally accepted standards. Meeting these requirements for water and environmental samples initially introduced labor-intensive procedures to ensure compliance, such as sample tracking and chain-of-custody (COC), record keeping, demonstration of capability (DOC), document control, reagent and standard traceability, and proof of user training and reporting.
For several years, Nova managed its laboratory data using paper-based methods supported by an out-dated laboratory information system. However, the system only allowed entry of coliform data, had limited reporting capabilities, and could not sustain Nova’s expanding business in the areas of microbiology, medical device and pharmaceutical testing. In addition, since the old system was located on one computer, only one employee could use the system at a time, which created bottlenecks in the laboratory and significantly limited the volume of samples that could be processed in a given day. Nova realized that it needed an automated data management system to support its growing needs and ensure regulatory compliance.
Microbiology testing is not like chemistry, which can usually be distilled down to a final set of numbers. A biological organism can be entirely unpredictable, posing significant analytical challenges, as illustrated in the recent E. coli outbreak in Germany. One hurdle for the proposed system was to be able to manage the data generated from both disciplines within the same environment.
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The solution
Initially, Nova commissioned a consultant to help draw up requirements for the vendor selection process. It was concluded that the new system needed to be user-friendly, easily maintained and configurable, versatile, Web-based and capable of complex reporting requirements. It also had to be able to support multiple user access and meet all of Nova’s regulatory requirements. Following this initial step, Nova took a very inclusive approach to the vendor selection process, with the whole team listening to each of the vendor presentations and scoring them against a predetermined list of criteria. Based on employee votes, Nova selected Thermo Scientific laboratory information management system (LIMS), integrated with NextDocs Document Management System (DMS), implemented as one cohesive solution in its Texas facility.
The Thermo Fisher presentation and demo were based on Nova’s complex needs, and the integrated LIMS/DMS solution was chosen due to its ability to cope with the chemistry aspect of the laboratory operations and the challenging microbiological variables that the lab encountered. Thermo Fisher’s track record as a provider of LIMS solutions to the water and environmental industry also played a key role in the vendor selection process.
Implementation and results
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| Brenda Bates, Nova Biologicals Laboratory Manager, is a member of the team involved in selection, implementation and rollout of Thermo Scientific LIMS. |
The implementation of the integrated system was carried out by both vendors as one seamless supplier in order to provide a complete solution for Nova. Both during and following the implementation, the vendors also were charged with the task of training management and laboratory technicians on the most efficient use of the system.
Overall, Nova is delighted with the benefits that the new solution has brought to fruition, many of which were not even anticipated. Up to five people now can process samples at any one time, allowing Nova to cope with as many as 1,500 coliform samples in one day, while also eliminating staff bottlenecks and saving many man-hours across the company. In addition, through the WebAccess feature of the LIMS, laboratory staff, remote users and external customers can enjoy secure access to the system from any computer, as long as they have an Internet connection and a Web browser. All system users can view the same information, ensuring consistency and clarity.
The LIMS and DMS also have helped Nova to significantly decrease the amount of paperwork used in its processes and methodologies, saving time and reducing costs through improved production efficiencies. Manual transcription processes have been eliminated and data quality has been improved, enabling Nova to provide its clients with more reliable information. The company now can tailor reports to individual customer requirements, offering a bespoke reporting format to a wider customer base.
Since all staff have been trained and are comfortable with the new system, all laboratory analysts, regardless of the department in which they work, are now able to receive deliveries when their shift patterns require them to work on a Saturday and enter the samples in the LIMS. This results in considerable cost and time savings, since specific personnel are no longer required to be scheduled on an extra day of work.
The integrated solution also has been instrumental in helping Nova maintain its NELAC accreditation in the state of Texas. Having all data stored in chronological order, with dedicated authorized folders sorted into months and years, has simplified and accelerated the auditing process. Managers also can now review records weekly, instead of monthly, making internal auditing more efficient. In addition, staff training records can be automatically updated into the DMS, leading to higher confidence and speed where auditing is concerned, and allowing Nova to easily demonstrate compliance with regulations. Following implementation of the new system, Nova was successfully audited by the State of Texas for NELAC accreditation in March 2010.
View to the future
Having enjoyed these benefits within its water and waste water operations, Nova is now in the process of rolling out the system to cover the pharmaceutical, nutraceutical, medical device, cosmetic, and food and beverage microbiology testing side of the business. This covers the remaining 47 percent of samples processed in Nova’s laboratories.
The types of microbiology testing carried out by Nova on behalf of clients include testing antibiotics, antimicrobials or disinfectants against aerobic and anaerobic bacteria, as well as testing yeast, molds and viruses to determine their inhibitory or killing effects. Additionally, Nova tests client samples, such as raw materials or finished goods in the medical device, cosmetic, food or beverage industries, for sterility, the absence of aerobic and anaerobic bacteria, yeast, molds and viruses.
Conclusions
By investing in a LIMS/DMS integrated solution in its water testing facility, Nova Biologicals has been able to reap all of the benefits of increased data quality, reduced compliance burden and elimination of bottlenecks. Moving from paper-based records to an automated, multi-user electronic system has enabled the company to maintain its NELAC accreditation in the state of Texas, refine work processes and improve reporting to customers in terms of data quality and speed of response. Nova has found increased customer satisfaction and has been able to increase capacity, expanding the services it offers beyond water and wastewater testing as a result of deploying a flexible system that manages and maintains the laboratory information it produces.
Paul Pearce is CEO and Founder of Nova Biologicals, and Colin Thurston is Director of Product Strategy, Process Industries, at Thermo Fisher Scientific. They may be reached at [email protected].
