This month, Purdue Pharma L.P.(Stamford, Conn.) will formally roll out the "Paperless Lab," a platform that has been some four years in the making.
Components of the project have already been in place at the company's R&D facility in Ardsley, N.Y., but will now be deployed globally, at R&D facilities in Cambridge, U.K. and Limburg, Germany. The system allows researchers, using wireless notebook computers (Photo), to record data directly while performing experiments, instead of having to stop to record data during each step. Results of experiments are immediately available for use throughout the organization and for assessing cGMP compliance.
The next step will take this platform into manufacturing quality control. Purdue has begun to install portions of the platform at its QC laboratories in Wilson, N.C. and Totowa, N.J. "We hope to build on our successes in R&D and continue full deployment of the Paperless Lab for QC," says Guy Talbot, executive director of research systems, based in Ardsley. "We don't yet have a firm timeframe for this second leg of the project," he adds.
However, in the future, the paperless platform could be used in manufacturing. "The return on configuration effort would be even greater there," Talbot says, "since specific analytical procedures tend to be run many more times in a manufacturing setting than in a developmental lab. " Applications could include managing data for release testing of production batches; scheduling and testing stability samples, and managing the in-process testing performed during batch production, he says.
A number of different software products fit together to form the Paperless Lab:
- Laboratory workflow and management of test results, as well as management of R&D's stability program, are provided by Lab Ware LIMS (Wilmington, Del.)
- Electronic execution of analytical test methods is handled by SmartLab from Velquest (Hopkinton, Mass.)
- Milford, Mass.-based Waters Corp. provides Empower software for data acquisition and Nugenesis Unify/Vision for instrument data capture; and
- eDocCompliance from Qumas (Florham Park, N.J.) is used to manage compliance documents in the labs, including approved test methods and specifications.
Nemonth, Talbot says, the company hopes to have most of these systems seamlessly exchanging data with each other so that, when a test is assigned to an analyst in LIMS, the appropriate procedure is initiated, automatically, in SmartLab. Sample preparation information recorded while the method is executed in SmartLab is then automatically passed through to Empower. Calculated test results are passed back to LIMS, where they are checked against specs.
The SmartLab system allows users to capture all the "metadata" associated with a particular data point, Talbot explains. For example, when you weigh a sample, GMPs require that you capture the weight, identity of the balance, calibration status, last calibration date, identity of the sample, and identity of person doing the weighing, time and date of the weighing. SmartLab allows all of this information to be captured, much of it automatically.
The software also makes it easy to review executed methods, Talbot says, to ensure that all required data have been recorded and are within acceptable limits. Values that are out of limits are flagged clearly, so that the user can easily find any potential problems.
Purdue has already realized significant improvements in efficiency and reduced errors. In R&D, they found that the use of SmartLab alone could cut method execution times in half, both by speeding up recordkeeping and simplifying peer review. The system should also speed the compliance process, making auditing easier and resulting in more trustworthy data, since any document's genealogy, and details on how it was produced, can be easily traced back to raw data, without the overhead of managing a paper system, Talbot says.
The major challenges with this project have involved project management, particularly system qualification. "We had to become a lot more sophisticated about computer system validation," says Talbot. There were organizational challenges as well. "A project like this is more a business reengineering project than a technology project. Analytical chemists, laboratory managers and quality assurance professionals all had major changes to their job functions," Talbot says. "Building broad-based understanding and acceptance of these changes over the life of the project required constant attention and communication."
E-compliance aids calibration, IT validation
Purdue is using paperless "ecompliance tools" to improve efficiency in other areas as well, as Dr. Talbot discussed in a presentation last month at the International Meeting on Automated Compliance Systems in East Brunswick, N.J. Use of Velquest's ePMC, he explained, has streamlined physical inventory of controlled substances. It has also facilitated calibration management, since all data generated during calibration are collected in one system--instead of the typical solution, in which only multimeter output, rather than the calibrated instrument's output, is recorded. Out-of-tolerance calibration results are automatically flagged, while the same tools are used to run instrument calibration procedures and test methods, so no additional training, system validation and infrastructure us needed.
The software has also proven extremely helpful in validating computerized systems, providing tighter control and fewer errors than the paper process, simplifying management of screen shots, and allowing for 33% faster script execution and 50% faster review, Talbot says.