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Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses the benefits of automated processes.
Q.We are manufacturing drug substances (APIs) and drug products for a global customer base. Many of our processes are manual, and the majority of our documentation is on paper. Although we have an excellent inspection record and a satisfied customer base, we are concerned about the need to increase our level of automation. Should we move to automated systems such as electronic batch records (EBRs)?
A.Though regulations do not explicitly require firms to apply automated systems, they do require the industry to apply current good practices, which may well be automated/electronic processes rather than a manual/paper system. FDA, for example, describes the need to evaluate automated solutions in various Form-483 and warning letter observations (1, 2).
Manual operations carry the risk of human error and often require verification by a second person. Similarly, handwritten records typically require confirmation of accuracy and completeness by a third party. While this time-trusted practice has historically proven to be effective, there are more efficient ways to operate, especially with the technology advancements available today.
When records are kept on paper, there is a need to transcribe data and information to prepare essential documents, such as the annual product quality review, trend information (e.g., monitoring of corrective actions and preventive actions), statistical evaluations (e.g., for process capability), and others. In addition to being time consuming, manual transcriptions are prone to errors.
Automated/electronic systems have distinct advantages and provide functionality that manual/paper systems may not be able to offer, such as making information accessible anywhere and anytime. For many applications, well-established computer systems or programs are available. Some programs have become industry standards, including enterprise resource planning (ERP), laboratory information management systems (LIMS), chromatography data management systems (CDMS), and building management systems (BMS). The question is not whether there is a system, but rather which system is right for your particular needs and purposes.
A major misconception, however, is that automated systems will do the work for you. While they perform transactions for which they were programmed, they do not replace human intellect. Typical examples are change-control or deviation-management systems, in which automated systems provide functionality for process flows, alerts, and searches. Descriptive texts, assessments, and logical conclusions, however, must still be recorded and entered by a human. Automated systems do not necessarily free up resources; they provide a framework and tool set for managing these processes more efficiently.
For making the transition to more automated/electronic systems, the answer ultimately depends on individual needs and circumstances. Take electronic batch records. If your operational environment (manufacturing and analytical laboratories) already provides much of the data in electronic format, then the data (e.g., weights, temperatures, times, analytical results, etc.) can be imported electronically. The batch records can then be reviewed online by the quality assurance department, which can increase efficiency. Use of electronic signatures is another option provided by most EBR systems.
If you want to replace second-person verification of critical entries by the computerized system (automated verification checks), then the EBR could be the right solution for you. Additionally, if access to the records is an issue, then electronic versions can provide much more versatility. Keep in mind that such automated systems, especially highly configurable ones like an EBR, require full and diligent computerized systems validation, a task that requires significant amounts of time and resources.
Automated systems are a bare necessity in today’s enterprises, but they are not a cure all. They are useful, providing functionality that is otherwise unavailable, and well established. In terms of the right system for your business, prepare a SWOT, or strengths, weaknesses, opportunities, and threats analysis of your existing systems and develop an automation strategy based on the findings. If this is not something your teams are familiar with, there are many companies who can assist.
1. FDA, ORA FOIA Electronic Reading Room, accessed Sept. 9, 2014.
2. FDA, Inspections, Compliance, Enforcement, and Criminal Investigations, Warning Letters, accessed Sept. 9, 2014.
About the Author
Siegfried Schmitt is Principal Consultant at PAREXEL International.