The LIMS implementation was divided into cycles reflecting the production flow starting with raw materials through the packaging cycle, the semi-finished and finished products and stability. The CDS implementation was divided into four areas: solids, liquids, validation and residue analysis, because of the different types of inputs and reports specific to each one of these areas.
A seamless integration of laboratory instruments to the LIMS and the LIMS to the ERP system by GPSG Brazil supports full regulatory compliance. For example, the U.S. Food and Drug Administration’s 21 CFR Part 11 standard covers storage and integrity of computer systems data. Controlled and traceable versions of the original data are created and the whole history of any modification carried out is securely stored, thus assuring complete system validation. The CDS/ LIMS integration also supports and enables the periodical auditing of the supplier certification system utilized by the company to guarantee the quality of its raw materials. Galvao explains: “The LIMS/CDS solution achieves quick and accurate transfer of high volumes of data, increasing sample throughput and improving laboratory productivity.” In the case of failed data, the company can track both the original failed result and the actual chromatograph in the system. In this way, GPSG Brazil is able to find out if there was an operator error or a serious issue that would impact the quality of the product so as to take all of the appropriate actions to protect consumers. “Since the LIMS provides increased traceability, the system enables easy and quick access to background data associated with batches allowing for automated batch control,” adds Galvao.
The integrated system detects changes in the production line, determining new analyses to be made. Chromatograms can be viewed during the analysis, and the workbook can be customized in order to view the analytical results. All required modifications may be performed in advance, preventing unnecessary and time-consuming rework. The configuration of a list of user profiles enables controlled access to the system as well as to certain functions, efficiently protecting data. The use of this resource allows data to be available as a function of the user’s responsibility and his/her role in the laboratory. In addition, the system may incorporate a sequence and/or levels to allow access to the workbooks. The configuration of auditing actions for each user category makes it possible for researchers at GPSG Brazil to trace the modifications performed in the workbooks, record the names of the individuals who performed a given action, determine when it was performed and what was modified. Even if the network fails, data are safe since protection mechanisms ensure the workbooks’ integrity.
The implementation has enabled GPSG Brazil researchers to view information that was previously only available in data reports. As a result, delivery of results has been accelerated since fewer steps are required within the analysis process. Further fundamental functions are also offered such as the ability to withhold and return acquisition queues, full-screen chromatogram expansion and baseline editing defects correction. Additionally, the acquisition date is displayed on the chromatogram’s screen. This precludes an analysis sequence from being saved over another one, thus ensuring the integrity of the original data. “The overall integration of our connected informatics solutions provides a seamless and secure quality environment at GPSG Brazil,” says Galvao.
TO THE FUTURE, NOW
The LIMS is integrated with both the enterprise via the SAP system and the Janssen-Cilag proprietary documentation system. GPSG Brazil is also looking for enhanced integration of its chromatography data system, aligned with a company upgrade of Thermo Scientific Atlas CDS intending to link the CDS to SAP in addition to the existing integration with the LIMS. When the system migrates from the data servers to the 247 controller, GPSG Brazil will include the 3D spectral analysis module.
“In addition,” says Galvao, “the LIMS has the potential for integration with other business systems. With a longstanding LIMS in place, we are confident that we can meet any future challenges. And our CDS is flexible to deal with changes in our procedures and guidelines. If the data reliability is already high with our Atlas 2000 system, whose task is to collect process and ensure the safety of chromatographic data, then this reliability will be enhanced further with the new version.”
The connected integration solutions deployed in its multiple laboratories help GPSG Brazil to guarantee tight quality control throughout its business processes in compliance with strict regulatory controls — from material delivery, through production, packaging and distribution, to worldwide customer service. For GPSG Brazil, these systems are capable of storing data and methods in a safe and consistent way, thereby ensuring ultimate data security and integrity as well as effective processing distribution. As a consequence, the company is able to easily, timely and effectively access data in order to make better informed decisions in a faster and more reliable fashion. Galvao says, “With Thermo Scientific CONNECTS, GPSG Brazil is supported as processes change and business needs evolve.”