Chromatographic analysis requires a chromatography data system (CDS) to interface with instruments. The CDS is required for data acquisition, management, processing, reporting, and distribution. While this technology has evolved over decades—from the strip chart recorder to the PC workstation to the client-server network—a major limitation persists: data processing takes at least as much time as operating the chromatography system. The following case studies illustrate how a truly modern CDS uses a universal language to dramatically improve efficiency and compliance, and streamlines method validation.
CDS harmonization enhances efficiency
A diverse chromatography software landscape creates challenges for productivity. In this case, a generic pharmaceutical company using multiple LC and GC instruments with software from different vendors was experiencing bottlenecks during batch release.
The analytical research and development laboratories, as well as the production-related laboratories, used specific workstation software from multiple vendors. This approach required a significant time investment to ensure all staff received proper training to use each system effectively. It also led to inefficient data management, as chromatography data was stored on various drives, discs, spreadsheets, and even paper documents. Maintaining validation for each different software also became a complex and time-consuming process.
To address these problems, the company selected Waters™ Empower™ Chromatography Data System as the new CDS. The key factors that influenced this decision were the software’s GMP compliance technical controls, ability to control instruments from a variety of vendors, and ability to interface with the existing laboratory information management system (LIMS). Empower was introduced as the standard CDS in the analytical research, development, and quality control laboratories, and was deployed as independent networks for each site.
Harmonizing the CDS significantly improved operational efficiency. An integrated e-signature process and the dissolution option—necessary for laboratories in a generic pharmaceutical company—had the largest impact on efficiency. Training time was also reduced, as Empower enabled staff to control a wide range of UPLC, HPLC, and GC instruments from different vendors. All chromatography data became readily accessible and easily exchanged between different sites, and maintenance and validation efforts were reduced. Overall, implementing Empower CDS improved efficiency and reduced bottlenecks during batch releases.
A networked data system improves compliance
Contract Manufacturing Organizations (CMOs)—especially in the international market—are subject to audits and inspections by regulatory agencies and customers on a regular basis. A major challenge for laboratories that rely on un-networked personal workstation chromatographic systems is manually maintaining projects and methods for individual instruments. This case illustrates how a pharmaceutical active ingredients manufacturer implemented a networked CDS to reduce compliance efforts.
The manufacturer had two Current Good Manufacturing Practice (CGMP) sites. One site had 20 HPLC and UHPLC instruments and nine users, and the other had five HPLC instruments and three users. To manufacture a wide range of products, the sites used nearly 30 synthesis reaction categories and each required quality control testing and review.
Quality control testing required numerous separation methods that were carried out on un-networked personal workstations and maintained manually. As a result, staff at both sites spent a large amount of time each month preparing for audits and inspections by regulatory agencies and customers.
The company decided to migrate from Empower CDS workstations to an Empower CDS network to support regulatory compliance efforts. This shift dramatically improved efficiency, data security, and compliance. Methods created on a single system could be used by all compatible chromatographic systems in the network, and data was backed up automatically from the individual systems to the Empower server. Validating a single network CDS, compared to 25 separate workstations prior to migration, led to a 20 percent reduction in qualification and validation efforts and a cost savings of 50,000 Euros per year.
A comprehensive solution for method validation
Chromatographic method validation must be executed properly to facilitate compliance. Traditional validation methods require manual data entry and are prone to errors. This not only impacts productivity, but can also delay new product introductions to market. In this case study, we examine an enterprise-level solution for method validation.
Within a global pharmaceutical company, reliance on a variety of different tools—each with different capabilities—created process inefficiencies in method validation. The company sought a solution that would incorporate corporate-driven, template-based standard operating procedures (SOPs) for managing validation procedures, as well as a secure database to support 21 CFR Part 11 compliance.
The company implemented Waters Empower Software Method Validation Manager (MVM) to address the limitations and bottlenecks associated with chromatographic method validation. Empower MVM enabled analysts to incorporate SOP parameters within the CDS software, displayed validation status, alerted users to results outside of specifications, and automatically confirmed that each validation parameter adhered to SOP requirements.
Empower MVM also enhanced data integrity compared to traditional validation methods. It provided audit trails, tracking injections for each validation test, secured traceable data within the Empower database, and offered greater control of user activity with designated privileges.
A scientist within the global research and development division noted that activities unrelated to sample preparation initially accounted for approximately 60 percent of time required for a method validation study. After implementing Empower MVM, he estimated a reduction to just 10 percent of total time and reported greater confidence that the method validation data was secure and traceable.
Waters Empower: The modern CDS
According to Neil Lander, Empower Principal Product Manager at Waters, what really sets Empower apart as a truly modern CDS is the full suite of features: compliance tools, a wide breath of instrument control, interactive system suitability, the choice of peak integration algorithms, ability to automate calculations (including impurities), and ability to carry legacy data forward.
Neil works with a variety of customers, and has heard many of successes the laboratories have had with Empower. A common comment is the time savings achieved with Empower MVM. The automation and simplification of the method process often results in a time savings of up to 80 percent. Many customers share these stories in Neil’s Empower Tip of the Week blog. Recently, a customer shared how leveraging tools in Empower to standardize products using automation to perform calculations has increased productivity within the organization by about 70 percent.
These case studies and customer stories are only a few examples of how Empower Software has been implemented to improve efficiency, compliance, and facilitate method validation—ultimately helping laboratories to elevate and grow their business.
To learn more, visit: www.waters.com/Empower.