Bioprocess Development Forum - Insights, Solutions, and Shortcuts in Bioprocessing

The importance of both technology and people in the modern laboratory.

By Amber Lowry

Understanding the role of both people and technology in the maintenance of data integrity in the analytical laboratory is crucial as companies move toward predominately electronic systems. While technology has helped make the preservation of data easier, it is just as important that the people operating these systems are aware of the relevance of each step involved in the process, says Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes. Hayward spoke with Pharmaceutical Technology about what it takes to successfully maintain the integrity of data in the modern laboratory.

PharmTech: What is most important to consider for lab data integrity?

Hayward: The people in the lab and the digital solutions they use play an equal role to ensure data integrity. Technology helps to make it easy to execute, as well as to proof integration. The technology of the past decade has allowed for better preservation of data, from the time of capture in electronic format through to its analysis and use in reports. 

This digital thread of information can now be preserved throughout an organization, but it is critical that the people who use the technology are aware of why each process step is relevant, and adhere to them at all times.  Automation is also a key factor. The best way to ensure this consistency is by making it easier and less time-consuming to perform each routine activity, while passively recording each action for regulatory compliance. This can be achieved by automation-enabling technology.

PharmTech: How can data integrity in the lab be improved by the use of electronic systems?

Hayward: Electronic data systems that automate data transfer allow for the reduction or even elimination of human intervention, and therefore, the reduction of errors. Audit trails will prove the integrity of the data or show the details of the change. This means any data alteration--voluntary or involuntary--will be either not possible, or any changes will be recorded so it will be obvious that data have been modified. 

PharmTech: What are the data integrity risks associated with computerized systems and how can they be diminished?

Hayward: In the modern lab, it is a fact of life that there will be multiple electronic informatics systems, where the landscape’s complexity has usually scaled with the size and age of the company.  Data are constantly passed back and forth amongst these systems, and may be transformed during the process.  At each step along the way, the process must be validated to ensure that the integrity of the data, and the digital thread of information, is preserved. Recently, the trend has been toward consolidation of these disparate systems into more comprehensive solutions, where the data are stored in a single, centralized system and accessed as needed, without the need for constant transformation and transposition. While validation is still necessary, this removes both the day-to-day complexity in the lab and much of the risk of compromised data integrity.

PharmTech: How can manipulation of electronic records be identified and prevented?

Hayward: In the lab, all data files should only be accessible through a software system which requires secure user login, and tracks all modifications as part of the audit trail. A computer’s operating system-level login is not sufficient for this purpose.  Although many solutions exist to enforce audit trails, in many cases, a user must log in to multiple different systems, sometimes more than once, just to complete a single task.  With ever-increasing regulatory requirements, routine tasks can take longer. A goal in the modern digital lab is to minimize the number of systems a scientist must use for any given tasks, which increases efficiency, centralizes the management of audit trails, and minimizes the potential for data corruption or manipulation.

PharmTech: What can companies do to improve lab data integrity when using electronic systems?

Hayward: Many paper-based processes have already been eliminated from the lab during the first wave of digital lab solutions. However, the multitude of different electronic systems in place, often from many different vendors, means that data still must be transposed and often transformed as it moves from one system to the next. Each of these steps must be configured and validated to ensure both regulatory compliance and the preservation of the data’s integrity.  Where possible, systems should be consolidated to remove the multiple different data file types and connections between software from different vendors.  It is also of the utmost importance that users are appropriately trained on the systems, and that their qualifications kept up-to-date.