Justification and Expected Benefits of Data Analysis Automation Projects

By David M. Harcar
President
DMH Consulting, Inc.

Data Analysis Automation

Categories of Expected Benefits

Quality and Compliance
Time
Resources
Validation and Support Costs
More Frequent Use of Analytics for Decision-Making

A properly-implemented and validated enterprise-wide statistical analysis solution provides clear benefits in the areas of compliance, resources, and cycle times. This article considers the expected benefits and justification of automating data analyses within Research & Development and Quality Control laboratories using an enterprise-wide data analysis software solution. Although targeted towards the regulated industries, other industries would benefit from the information as well, since opportunities abound across all industries for delivering business value through the consistent and timely application of analyses and reports for ongoing decision-making.

The need to automate ongoing data analyses in the lab is usually obvious to those involved. A typical scenario of a manual process for data analysis follows:

1. An analyst manually compiles data from multiple sources, such as databases, spreadsheets, and paper reports. The analyst may need to contact a database expert or system owner to request the relevant data. This request may have its own issues with timely response and data accuracy.
2. The data is then hand entered, copy and pasted, or imported into a desktop application that will be used for data analysis. Multiple applications may even be used, such as Excel for tabulating the data, and a separate stand-alone application for statistical analysis.
3. The actual analysis is performed, often by fine-tuning and modifying the previous analysis until the desired affect is achieved.
4. The final data is printed and often goes through a management and/or quality review process.
5. If the final report needs to be reviewed months after it was generated (such as during an audit), the question as to where the data came from and how the calculations were performed is often difficult, and prolonged in itself, to answer.

The analyst may be the only internal "expert" on the complex manual process.

The overall manual effort is error-prone and time consuming. In fact, the effort can be so complicated that analysis may be ignored entirely, simply because there are no resources available. The organization went to a lot of trouble to collect and store the data, but never receives the full benefit of retrieving and analyzing it.

Obtaining approval to proceed with a statistical analysis automation project requires a clear and comprehensive definition of the benefits. What follows is not an exhaustive analysis of benefits, but should provide enough information to get started with the project justification.

Quality and Compliance

• Eliminate transcription errors Manual data entry and manipulation results in data errors. When data is hand entered, some of it will be entered incorrectly. When data is copy and pasted between applications, sometimes the wrong data will be selected for copy. These types of manual errors are unavoidable, and even difficult to minimize.
• Consistent data analysis and reporting of results Providing a well defined, standardized, and validated means of retrieving, calculating, and reporting data provides analysts with a straightforward process for performing the analysis. The analysis is locked down and can only be changed by authorized personnel, and a history of changes is maintained in the system. Management and Quality has confidence that the data and calculations are accurate and consistent over time. During audits, regulated agencies are assured that the organization has their act together.

Time

• Reduced cycle time Reducing the time it takes to perform data analysis is one of the most obvious benefits of automation. Time savings are frequently realized both in the time it takes to generate each report, and in the time that quality spends reviewing the results. When a consistent validated solution is introduced, quality review should be reduced significantly. To accurately determine the time savings, these questions must be answered:
  • How many different statistical reports are generated?
  • How many person hours does it take to manually perform each analysis?
  • How many person hours does it take to review the results of each analysis?
  • When the automated solution is delivered, how many person hours will it take to generate and review the analysis?

Resources

• Reduction in resources is also one of the most obvious benefits of automation. Again, the savings are realized in both the resources it takes to manually generate each report, and the resources that quality spends reviewing the results. These resources are then freed up to be redeployed on other initiatives within the organization. An often overlooked benefit is a careful consideration of how these resources will be redeployed. Redeployment is often documented simply as "Redeployed", with no mention of how or where.

Costs

• Direct cost savings needs to be carefully considered. Any cost savings need to be carefully weighed against the cost in implementing, validating, and supporting the solution. In projects with a large scope, the cost benefit may be realized over a period of several years.

Other

An often overlooked benefit is an increase in the volume of analysis. After the process is automated, employees find out how easy it is to analyze the data. So they start doing it more frequently. Where before it was only done when absolutely necessary (if at all), now it becomes a routine part of their jobs.

There can be many challenges to getting project approval, such as a lack of funding or insufficient resources. However, a properly justified project will demonstrate to management the full benefits of the initiative, and therefore increase the likelihood of approval.

DMH Consulting provides IT consulting services to R&D and QC laboratories in the Pharmaceutical and Healthcare industries. David Harcar, owner of DMH Consulting, has eighteen years experience working on IT laboratory automation initiatives, such as LIMS, Chromatography, and Statistics, with experience in full lifecycle Project Management, Computer System Validation, and Information Technology.

David Harcar
Owner, DMH Consulting, Inc.
(215) 815-3251
dharcar@dmhci.com
www.dmhci.com