GLP Management

Top Benefits of Electronic GLP Management: What Non-Clinical Research Laboratories Should be the First to Know
by Diane Clements

Industrialized nations, such as the United States, the European Union and Japan, have increasingly aging populations and are experiencing unprecedented growth in demands for healthcare and related technologies.

Life science companies, as active players in the quest to meet public healthcare demands, are striving to produce more products while maintaining and improving product quality.

Research Environments and GLP Compliance
Generally, life science companies that focus on manufacturing or clinical studies are dependent on the research provided by non-clinical research companies/organizations. The research provided by non-clinical research facilities provides the foundation not only for emerging products but for the initiation of a regulatory audit trail that lets GLP (Good Laboratory Practice) regulators know that a research study is on the right track.

Not Enough Time
To keep up with intense competition, non-clinical research facilities not only rush to balance good science and GLP compliance but are also pressed to provide all of this foundational information at faster rates. This difficult balancing act leaves non-clinical research professionals looking for ways to more effectively automate iterative processes associated with GLP compliance.

Electronic Automation: Solution Requirements
Many non-clinical research professionals may be hesitant to invest in electronic solutions for GLP compliance because 1) they are not sure the solution will be effective, 2) many of their current processes have already been successful and 3) they are not sure what solution requirements they should look for. The following information will help research professionals identify the solution requirements they need to automate GLP processes and gain a healthy ROI.

The Benefits of Electronic GLP Management
Many of the greatest benefits of electronic GLP management are directly associated with quality audit and documentation automation. Of course there are other aspects of GLP compliance that can be effectively automated and research professionals should look for a solution that can automate processes associated with a GLP, GCP, GMP and additional quality related processes. This article however will focus mainly on the benefits of GLP related quality audit and document automation.

Benefit #1: Real-Time Data
Managing GLP quality audits often takes so much time that once the results are presentable and have been analyzed for deeper leading indicators, the information is weeks or even months old. This leaves top-level decision makers wondering how applicable their decisions are when their main sources of audit information are outdated. A solution that streamlines quality audit management processes and allows auditors to collect, organize, trend, and report on data in only a fraction of the time it would normally require allows auditors to present fresh data that decision makers can be confident in.

Look for Solution Requirements
Research professionals should search for an electronic solution that automates and centralizes the collection, organization, trending and reporting of quality audit data.

Benefit #2: Information Consolidation
When quality audits and GLP related documentation are managed by various people who utilize different systems, distinct audit forms and varying tools, quality audit information can quickly slide through the cracks and quality audit processes will inevitably suffer. Using an electronic solution to consolidate all audit related information or GLP related documentation helps non-clinical research auditors communicate more effectively, streamline processes and save valuable time that could be more efficiently implemented elsewhere.

Look for Solution Requirements
Research professionals should search for an electronic solution that consolidates all audit information into one centralized system and that allows for the control of GLP related documentation.

Benefit #3: Process Automation
It isn't good enough to simply centralize quality audit information. Information has to be streamlined and connected to other automated processes.

Look for Solution Requirements
Research professionals should search for an electronic solution that automates processes associated with the routing of audit information, notification reminders, schedule notifications, audit data tracking, report creation, document control and document routing.

Benefit #4: Local and Global Reports
The expansion of life science companies and contractors to a global level presents a relatively new challenge for non-clinical researchers. Quality auditors must create not only localized reports but globalized audit reports. Varying languages and the need for speedy distribution of these reports simply begs for qualified automation.

Look for Solution Requirements
Research professionals should search for an electronic solution that allows auditors to create reports in one language and then translate that information (across various fields) into other languages. The solution should also allow for the flexible conglomeration of audit information. Local professionals for example may be interested in viewing a specific audit report while top-level decision makers may prefer to view a global summary of audit trends.

Benefit #5: Document Control
Document control is the essence of any type of regulatory compliance. A document trail must always be established.

Look for Solution Requirements
Research professionals should search for a solution that streamlines and more effectively manages all important GLP related documentation. A solution that will generate documents such as the Master Schedule and QA Statements and streamline and track these documents with version control and reporting features is also recommended.

Non-clinical research professionals should carefully consider the benefits of electronic GLP management. Not only will they save vast amounts time but can, with the right solution, gain a ROI in less time than they might expect.

Diane Clements is a executive consultant for MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (

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