By Gail Dutton, Contributing Writer
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Paperless lab information management systems (LIMS) are becoming indispensible tools to help companies boost efficiency in analysis, documentation, and review. The gains, according to new users Carbogen Amcis AG and Hoffmann La Roche Basel, have been substantial, shaving 10 to 20 minutes from analysis, increasing report accuracy, and cutting analysis costs by as much as 25%.
Neither company used a LIMS before implementing a paperless lab system. As Franz Breitfeld, Ph.D., head of QC & analytics at Carbogen Amcis, recounts, “Our entire lab workflow was paper-based. Raw instrument data was printed and archived, with copies for customers, internal use, and development partners as needed. The process was extremely inefficient. We spent much time searching and presenting the results.”
At Hoffmann La Roche Basel, “The paper- based process was only supported by MS Office tools,” notes Christoph Höfler, Ph.D., head of analytical development drug substance. “Instead of a LIMS, the analytical group used a simple Microsoft Access database to track samples. Templates for analytical reports were created in MS Word and completed by hand.” Customer sample requests were handwritten, too. Consequently, identical data was entered multiple times by multiple people, increasing errors and slowing the process. “Furthermore, results were manually calculated and transferred to analytical report templates by hand. The reports went to the customer by internal mail, unnecessarily delaying results delivery,” Dr. Höfler explains.
In implementing a paperless lab system, “The aim at Carbogen Amcis was to harmonize all analytical instructions and standard operation procedures for our three sites,” Dr. Breitfeld says. Therefore, the company conducted several workshops to discuss the internal workflow, addressing both current and desired workflows with the knowledge that technology could streamline or eliminate some procedures.
At the same time, Dr. Breitfeld notes, “Our acquisition strategy for analytical equipment changed, so only one supplier would be selected for a technology. Therefore, one dedicated interface program could be used for the same type of instrument at all three of our sites. In retrospect, it was one of our best decisions,” he says.
To transition from a paper-based system to an electronic lab management system, Carbogen Amcis focused on the analytical development and quality control departments. “In addition to a LIMS, we implemented a chromatographic data system (CDS) and a software application to connect all analytical instruments with LIMS through specific interfaces,” Dr. Breitfeld says.
When Hoffmann La Roche investigated a paperless lab system, “We approached our internal LIMS IT group and examined our sample workflow. Working with a dedicated lab team and our customers, we designed and implemented a complete paperless workflow within one year,” Dr. Höfler notes. The implementation eliminated redundant processes for the company’s analytical chemists and simplified sample submissions from the synthesis development department, thereby delivering better quality results faster.
The paperless lab system includes enterprise laboratory automation (ELA) and laboratory service modules (LSM) to link the LIMS, CDS, analytical instruments, and data repository, Dr. Höfler says. “All samples and tests are bar-coded for information transfer. Each CDS has a bidirectional embedded interface that transfers results and sequence information between the CDS and the ELA. A similar interface exists for the balance data. All human readable reports are stored as PDF files in the data repository and can be accessed directly from an add-on module within the LIMS.” This solution was designed for deployment to many departments and many sites, thus increasing synergy.
“Generally, there are no out-of-the-box solutions available for lab-specific workflows,” Dr. Höfler points out. “Substantial configuration and customization are still required for an optimal solution.” Both companies turned to Vialis AG, which specializes in interfacing instruments and paperless lab solutions.
Vialis custom designs lab management systems using components from multiple manufacturers. “We’re workflow-oriented,” emphasizes Paul Planje, Vialis’ director of sales. The Vialis approach integrates the system into standard operating procedures so the workflow proceeds naturally, and information is available as needed.
Both Carbogen Amcis and Hoffmann La Roche involved end users and IT specialists intensely in the systems design and implementation. As Dr. Höfler notes, “That led to very pragmatic solutions for the user requirements,” followed by further refinements during a two-month pilot before the system went live.
The main concern for Carbogen Amcis was that the system could be installed, configured, and operated easily by in-house IT specialists, without consultants. So the company developed a comprehensive LIMS user requirement specification and spent one year evaluating potential vendors. At the conclusion, candidates were narrowed to three and, after a detailed pilot demonstration, to one. “The chromatographic data system was evaluated in the same manner,” Dr. Breitfeld adds.
As Dr. Höfler emphasizes, “It is very important to cover all different instrument types during the pilot. For example, although all of our chromatographic systems are run by the same CDS, they required different embedded interfaces in the backbone to account for configuration differences.”
Carbogen Amcis staged the rollout to its three plants so they occurred one month apart, ensuring that each facility was operating smoothly before proceeding to the next site. Within those sites, however, there was a firm demarcation point. “On Friday evening the paper-based system was stopped. On Monday morning the paperless system started,” Dr. Breitfeld recounts. Projects beginning in the paper-based system remained there. Only new requests were executed in the paperless system, so records were not spread across two systems.
Before the transition, Dr. Breitfeld recalls, “We formed a data load team to input all master data (project codes, customer codes, reagents, instruments, methods, material types, raw material specifications, HPLC [high performance liquid chromatography] columns, etc.) into the LIMS.” At this time, the company also trained personnel to use the LIMS, providing Instrument-to-LIMS and LIMS-to-instrument procedures.
“During the first week after implementation Carbogen Amcis also fielded LIMS service centers, with LIMS team members present in the process research and development department, in production, and in the analytical laboratories to guide users through the new system. And, twice daily, we hosted a FAQ roundtable,” Dr. Breitfeld adds.
During the rollout, the entire 10-person LIMS team supported the rollout site, Breitfeld says, resulting in a user-to-supporter ratio of 15:1 for process research and production and about 8:1 for the analytical area. Carbogen Amcis also trained two or three people at each site as LIMS power users.
User resistance is the greatest obstacle to any new technology. “Training,” Dr. Höfler emphasizes, “was key for user acceptance. All users were trained by the core team before system rollout with demonstrations, followed by one-on-one lab sessions and online tutorials. We had a high acceptance for the new system from the very beginning.”
Consistent, high-level support also helps. “Our management stayed 100% behind the project,” Dr. Breitfeld says. “This is one of the important issues,” he emphasizes. “You need full support from everyone involved.”
Now, long after implementation, Carbogen Amcis and Hoffmann La Roche are reporting increased accuracy and efficiency, a streamlined workflow, and faster results. More specifically, “The paperless laboratory has reduced the analytical costs up to 25%,” Dr. Breitfeld says. At Hoffmann La Roche, “The biggest savings came from automating analytical reports, saving 10 to 20 minutes per analysis. Additional savings were achieved by automating sequence creation and eliminating redundant operations.”
Satisfaction surveys are positive. One year after implementation, a Carbogen Amcis survey reports that “90% of the lab personnel are highly satisfied with the new system and 10% want minor adaptations. No one wants to go back to the paper-based system,” according to Dr. Breitfeld.