Electronic Batch Records (EBR) applications are often the most significant investment a Pharmaceutical IT group can undertake in any given year yet offer a tremendous opportunity for streamlining manufacturing with digitized processes, reducing variation, ensuring operator compliance and providing a platform to improve and optimize operations in a secure and compliant way. By going well beyond manual processes, EBR allows pharmaceutical companies to tie together the various islands of automation, enabling a real reduction in the amount of time required to release batches while managing in a cost-effective way the regulatory requirements for documenting the actual production process on any given product.
However, EBR requires a commitment by the whole enterprise to connecting the various processes on the factory floor (i.e., the manufacturing line, packaging line, raw material receiving, chromatographs, etc.) whether automated or manual while implementing a system to collect and store large amounts of process data for future investigation and analysis. Depending on the approach, EBR can take a massive effort for implementation, lasting months to years, or it can take from weeks to months. An important consideration is the recognition of the differences between plant floor data and the business environment – which means a different set of tools than IT typically relies upon for the enterprise. A plant-wide historian that connects to all manufacturing systems as well as the enterprise can provide the foundation for making EBR ROI achievable. A process historian can lower the cost of implementation, help you improve EBR security and compliance, and offer you a way to leverage your investments to analyze manufacturing data to make significant improvements.
Not Just Any ArchiveMany pharmaceutical companies want to approach a manufacturing data archive in the same way they approach an enterprise archive – with a relational database. However, a relational database is rarely the best approach for the manufacturing floor for many reasons. First, manufacturing operates in real time requiring very fast data collection for best analysis purposes. A plant-wide historian provides 10-20 times faster read/write performance over a relational database and 1-millisecond resolution for true real-time data. Additionally, the plant-wide historian is optimized for “time series” data – while a relational database is built to manage relationships. For example, relational databases are great at answering questions such as:
– What batches were shipped last week?
– What was the largest order last quarter, and who was the customer?
A plant-wide historian, on the other hand, excels at answering questions that manufacturing typically needs to address to make a real difference in production. These questions can include:
– What was the hourly unit production standard deviation?
– What was the 10-minute interpolated average?
The historian is designed to deliver time-series data and calculations quickly, easily and efficiently – easing one of the most critical tasks an EBR application must undertake and providing an avenue to manufacturing process improvement.
Furthermore, with powerful compression algorithms, a plant-wide historian can store years of data easily and securely online – which aids performance and reduces maintenance for lower costs.
Cost ControlAs with any major enterprise-wide IT project, the costs and time to implement EBR can make achievable results and ROI appear to be far in the future. This is absolutely the case with a relational database architecture and the many custom interfaces required for implementation with real-time systems. Relational databases also require companies to manually create and manage custom tables – which can be time intensive. However, with a plant-wide historian, you can “normalize” the implementation, using standard interfaces for time and cost savings. There is also no management or creation of data “schemas,” triggers, stored procedures or views. With this ease of use, you can install and configure many systems in hours, and you will not need specialized services for the installation. In fact, according to one new historian user, the implementation “took 10 minutes to install all of the software, have tags configured and collecting data. Browsing and adding 14,000 tags took seconds.” An intuitive, graphical interface can make configuration simple. Compared to a relational database architecture and interfaces, a plant-wide historian provides approximately 50% reduction in implementation time. Long term, maintenance is also greatly simplified. With a plant-wide historian, no on-line maintenance is required. With a relational database, however, maintenance can be a full-time job, as companies must manage archives and disk space due to poor compression. Additionally, tag imports and maintenance must be performed during scheduled downtime as there is no on-line maintenance. With the time and cost savings offered by a plant-wide historian, pharmaceutical companies can put in place a foundation for EBR faster while reducing the on-going maintenance required for the system.
Security and ComplianceA plant-wide historian can also help pharmaceutical companies achieve improved security as well as compliance. Three key features of a historian can make it easier for companies to certify their implementation for 21 CFR Part 11 compliance. The first is the non-modifiable audit trail. The audit trail keeps a record of all system configuration changes and, as the name implies, cannot be modified. Secondly, “electronic signature” requires that all users must “sign” with their user name and password before any change is made to the system configuration. Furthermore, with the ability to log OPC alarms and events, pharmaceutical companies have a single, secure location for all manufacturing and production data – which makes it significantly easier to install and validate a historian – as well as access the data for analysis.
Analyzing Data, Improving Processes.A plant-wide data historian makes it possible for pharmaceutical companies to collect and analyze the tremendous volumes of information that are generated in their plants, so that they can improve performance, integrate the plant floor with their business systems, and reduce the cost of regulatory compliance. As stated by many Six Sigma quality experts, “you can’t improve what you don’t measure” – and EBR with a plant-wide historian foundation can make this possible. Data collection and analysis can help you increase the quality and consistency of your products by comparing past production runs, analyzing the data and plotting ideal production runs against in-process runs. With aggregated data, you can also prepare reports and share information over standard web browser tools.
Lastly, the plant-wide historian also serves as the vital link between plant operations and the business, providing business systems with the actual data they need to gain a clear, accurate picture of current production status or historical trends. This detailed information can yield numerous benefits, including the ability to let customers securely gain access to information on the status of their orders.
While EBR is a major shift from the manual processes at many pharmaceutical companies, it is achievable within a tight implementation timeframe and with proven ROI. By challenging traditional IT tools, you can explore opportunities to implement EBR based on a foundation that is built specifically for the plant systems – which will save time, speed implementation, reduce maintenance, improve security and compliance, and provide your company with a basis for analyzing data that was invisible in the past to make significant improvements. Not only can an EBR application provide a means of ensuring operator compliance procedurally, but by building the application on a process historian foundation, it can enable the beginning of process improvements and be the basis for addressing a program of continuous improvement, providing a positive return from this critical IT investment for many years in the future.