REDUCING REGULATORY RISKS
With paper-based records sometimes leading to documentation errors and non-compliance issues, the fact that EBR systems can help to address these is often an important factor in the decision to implement such technology. In fact, a recent LZ Lifescience survey found that 90 percent of those in the life science sector state that they spend a significant amount of time on compliance issues for regulatory purposes. Therefore, systems that can reduce the risk of errors and non-compliance are extremely valuable.
Furthermore, when using paper-based systems, potential issues are not always identified and recorded as they happen, meaning there is a delay in resolving them. This can cause greater complications down the line such as higher rejection rates for batches. There is also a time lag between using materials and updating the system, meaning the inventory is not always accurate.
Electronic systems can help with a number of regulatory factors, for example, compiling a summary of product characteristics (SPC), which is required within the European Commission before any medicinal product is authorized for marketing. Good manufacturing practice (GMP) data can also be integrated into a single system, ensuring the highest quality manufacture and minimizing risks that cannot be eliminated through testing the final product.
TRANSPARENT INFORMATION SYSTEMS
The visibility of information is critical during pharmaceutical manufacturing. In traditional paper-based systems, data can only be located manually and, in order for it to be analyzed, must be transcribed into a system. Due to the lengthy process, this means the information is sometimes out of date by the time it has been extracted. EBRs eliminate these issues, therefore keeping information relevant, as well as reducing the risk of any human errors during input.
Another benefit of migrating to EBRs is the ability to view data in real-time. This feature allows for issues to be picked up as they are happening, alerting teams to react promptly and potentially avoid disruption or downtime altogether.
In addition, real-time data capture also assists with regulatory compliance. Many pharmaceutical manufacturers use enterprise resource planning (ERP) systems to manage the supply chain and automation systems to control their manufacturing process. MES technology can bridge the gap between these two systems, ensuring information flows smoothly around the facility, assisting in the production of quality products, manufactured “right first time.”
LOW IMPLEMENTATION COSTS
In addition to the numerous operational benefits, MES solutions have the potential to generate a return on investment within just 12 to 18 months due to the low implementation costs provided by modular, flexible systems. By eliminating errors, allowing efficient and accurate data movement and improving regulatory compliance, these technologies have been shown to improve productivity by as much as 25 percent. This more than justifies the initial cost and operational changes that undoubtedly occur while the technology is implemented.
BEST PRACTICE APPROACH TO IMPLEMENTATION
Before starting the process of migrating from paper-based records to EBRs, pharmaceutical manufacturers must first establish solid project foundations. The deployment of an electronic system will affect all aspects of the business, not just the production line itself. As a result, the company must consider the challenges and benefits of introducing new technology and receive project buy-in from all levels of the business, but most importantly upper management, operations and quality.
However, establishing a business case is just the first step in the process. Once the need for the transition to MES and EBRs has been justified, it is important to review best practice for both planning and implementation, allowing the creation of a project plan.
Electronic systems have potential to impact planning, execution, control and documentation functions, as well as disrupting organizational structures, job roles and staff training. A key factor in ensuring success is therefore identifying a project champion who will drive the project forward. This person can ensure project plans are in place, take responsibility for briefing staff on new processes and delegate the various tasks that will need to be carried out.
Creating a project charter will allow you to establish accountability. Within this charter, clear goals should also be put in place to evaluate success. You must identify the key performance indicators (KPIs), which might include increasing productivity (increasing asset utilization) or improving regulatory compliance (decreasing the number of deviations).
As the project is likely to affect the whole organization, an effective way to ensure that everyone in the company is aligned is through a concept of operations (COO) document. This will outline daily operations plans, identify the benefits and explain the role of each organizational department for the duration of the implementation process and once the project goes live. The COO and project charter are critical in ensuring that the organization is prepared for the upcoming changes and the transition runs smoothly.
Once plans are in place, you can begin to initiate the implementation. This process first involves an analysis phase where existing business processes are converted into workflows, software functions and configurations. The software must then be qualified in accordance with established industry standards, such as the GAMP-5 validation model.
Following this, other key activities need to be performed to migrate from paper records to electronic reporting. This includes converting existing paper records into electronic forms and updating standard operating procedures (SOPs) to reflect the fact that paper systems are no longer valid. This is also where decisions must be made on which information should be included in SOPs and what is more appropriate for batch records. EBRs would include GMP and patient-related data, whereas SOPs would include information for operators and practical guides.
Once you are ready to go live, master and inventory data needs to be loaded into the production system. This involves transferring production records and the definition of material items from the quality system so that they can be properly approved.
The GMP data (such as Critical Process Parameters and Critical Quality Attributes) is of utmost importance here, bringing a number of benefits. First, it ensures that products are consistently produced to stringent quality standards, supporting the concept of “right first time” production. Additionally, inputting GMP data allows for the system to highlight any potential risks and issues that may occur during production.
It is quite normal to expect lower production output when the system first becomes operational as the company is still adapting to the new operating procedures. However, you can plan for this at the start of the project by perhaps increasing production before the changeover and ensuring customer expectations during this time are managed. You should constantly review and evaluate the system performance, particularly during the first six months. Review the actual performance against the KPIs and put a plan in place to resolve any potential issues. Once the system has been deployed, you should also consider and take advantage of new features, software upgrades and deploy new functionality. This will allow your system to remain relevant and efficient.
Although the process of migrating to MES solutions and EBRs has the potential to be challenging, with correct planning it need not be daunting. Essential drivers such as regulatory compliance, improved data accuracy and greater information visibility form an effective business case to make the transition. However, in order to ensure project success, each department within a pharmaceutical manufacturing organization must be engaged and on-board with the processes. Only then can you realize the high rate of “right first time” production that can be attributed to electronic data management and reporting.
