Merit Matters Blog

The Pharmaceutical industry is often considered a leader when it comes to the utilization of new, innovative technology to drive major advancements in R&D. However, we have found that when it comes to inventory, manufacturing, and supply chain management business processes – many Pharmaceutical companies still find themselves buried in paper.

While regulatory reporting and compliance requirements historically drove these organizations to work manually with paper, there have been many advancements in software technology that should be too compelling to ignore. Unfortunately, once manual and paper-based systems are in place, executives tend to stay with these systems in order to stick with their “tried and true” ways of working. And once they are awash in paper, these companies are so consumed in managing paper trails that they cease to see how crippled their operations really are.

By maintaining the status quo, these Pharmaceutical companies are ignoring the significant cost savings, efficiencies, and competitive advantages that electronic systems can provide.

The obvious challenges with historical paper-based processes are that they take a great deal of time, effort, and space to manage and maintain. Then take into consideration the added risk of human errors, overlooked requirements, and forgotten processes. And don’t forget about the raw materials and finished products sitting in the warehouse waiting for manual and paper-based processes to be completed. This represents tied up working capital and fewer inventory turns. All of this adds up to higher costs and lost profits.

Executives who recognize these challenges are refocusing their efforts in order to eliminate the paperwork and automate manual processes. They are looking for an electronic way to efficiently document any procedure, process, transaction, journal, COA, formula or recipe in a way that is compliant with 21 CFR Part 11 Regulations. This means they need built-in full document lifecycle capabilities, complete with automated workflows, audit trails, electronic signatures, approvals, versioning, and archiving. And they need all of this without paper printouts.

Today’s industry leaders that are improving performance in these areas are doing so with Electronic Batch Records (EBRs). Electronic Batch Records help Pharmaceutical companies eliminate costly paperwork errors, speed up information distribution and collaboration, and enable strategies for improving product quality and process efficiency.

Here are the top 7 benefits of Electronic Batch Records (EBRs) ERP Software:

• Improve accuracy and consistency - Unlike humans, an automated Electronic Batch Record system will do a programmed task exactly the same way every time. Humans have moods and are subject to sleep deprivation, attention lapses, bad attitudes and bad days. Automated systems do not, and perform the same way each and every time.
• Increase productivity - The most important driving force for a company's business success is its people. By providing employees with a familiar interface that quickly connects internal people - and even external business partners - to the right information and tools to work faster and smarter, companies can set the stage for increased productivity. Electronic Batch Records also eliminate time-consuming and error-prone data re-entry resulting from multiple, disparate, and paper-based systems.
• Reduce cycle times - A typical pharmaceutical manufacturing cycle time falls somewhere in the 30- to 90-day range, with batch releases alone taking upwards of 60 days. These cycle times typically double in nonconformance scenarios. Electronic Batch Records enforce the consistent execution of manufacturing steps while providing an accurate, real-time view of process and deviation data. The time associated with detecting, tracing, resolving, correcting, and documenting deviations in the manufacturing process within various paper documents is virtually eliminated.
• Reduce Compliance Costs - Compliance requires capturing information, accurately, organizing and retaining the information and quickly and efficiently analyzing and presenting it. This requires processes and procedures that are an integrated part of a company’s way of doing business. Electronic Batch Records systems help Life Sciences companies operate and manufacture products in a consistent and compliant manner.
• Reduce Operating Costs - The biggest cost of manual processes is people. It costs companies time (money) by manually performing tasks that can and should be automated and streamlined by technology. Automated systems also reduce the risk of human errors, which can result in redundant processes, rework, or even audits. Electronic Batch Records also eliminate the large costs associated with printing, reviewing, storing and retrieving paper documents.
• Increase Ability to Scale Rapidly - The idea we discuss with Pharmaceutical companies today is growing with muscle, not fat. When you grow, you have increased volumes going through your business processes, and variations in those processes based on different types of customers, orders, products, suppliers, etc. The disorganization potential of paper-based business systems is far more dangerous and prohibitive to a rapidly growing company.
• Improve Decision Making - Manual and paper-based processes store data in a disconnected and difficult-to-access manner. If data related to these manual processes is required for decision making, there is often a time delay in getting the data into a consistent, usable format. And because it is costly to gather the data, many companies decide to operate without it, which leads to decisions that are less optimal and often time delayed.

Make no mistake: the transition to paperless manufacturing (moving from paper batch records to electronic batch records) can be challenging. Employee pushback, systems validation, and incomplete or inadequate identification of requirements can put your systems and processes at a higher risk of failure. However, the competitive advantages and benefits offered by the use of Electronic Batch Records in modern pharmaceutical manufacturing are real, significant, and too compelling to ignore. When properly implemented and integrated with a Pharmaceutical ERP system, Electronic Batch Records can help companies increase profitability and maintain a competitive advantage.

MAXLife Electronic Batch Records (EBR) eliminates costly paperwork errors, speeds up information distribution and collaboration, and enables strategies for improving quality and efficiency. MAXLife makes it easier for Life Sciences companies to access and track batch records, model and change complex processes, and speed time-to-market.

Enterprise Resource Planning (ERP) software is designed to improve and automate your business operations. Within medium to large enterprise companies, these processes - such as quality, production, inventory, reporting, order entry, accounting, purchasing, etc... - are traditionally managed by several disparate, or even manual, systems.

Companies that operate with disparate or manual systems often experience many unnecessary costs and delays. Examples include duplicate data entry, data corruption, more training, greater IT support and software incompatibilities. However, the largest impact of disparate systems is the inability to access information timely to enable good decision making.

As a result, there is a growing trend toward the use of a single ERP system to manage the entire business.

Through this single software system approach, companies can control the details of their businesses by linking all departments together. This maximizes productivity, reduces costs, and increases profitability. With a centralized ERP system, companies can erase information boundaries and deliver the critical information needed for rapid, effective decision-making.

Here are the top ten business benefits of eliminating silos of data and utilizing a single ERP software system. By understanding these benefits, companies can understand how to simplify their operational processes.

1. Reduce Costs: Challenged to do more with less, many IT departments are finding that the cost of maintaining multiple business systems is simply too high. With a single software system in place, companies can eliminate many of the costs associated with IT, including high implementation, integration, training, and support costs. Additionally, many companies experience reduction in overall license costs when moving to a single business system approach.
2. Single Point of Control: Another major benefit of a single ERP system is the “single point of control.” A single software system will be the trusted source of information for an organization. By integrating all business processes into a single system, companies are able to simplify business workflow and increase productivity and efficiency.
3. Eliminate Redundant Data Entry. Eliminating redundant data entry improves productivity. Companies can also gain organization-wide insight across the applications through one easy-to-use and familiar interface. For example, inventory, formulation, production, and lot and batch control updates are processed once with real-time transactional posting.
4. Improve Data Integrity: As the sole system for all company data, enterprise wide ERP is perfectly suited for organizations that require high levels of data integrity and control. With a sin-gle software solution, business information will be entered in one central location and will always be the same across company departments and locations.
5. Better Business Insight: Access to business critical data - no matter where it's located - is needed for rapid, effective decision making. By integrating all departments into one business system, companies have accurate, up-to-the minute information about product costs, sales trends, profit margins, and more.
6. Respond to Changing Business Conditions: Responding quickly to business needs can be the key to gaining and keeping a competitive edge. But disparate IT systems can get in the way. A single enterprise wide software system that is flexible and easy to use can play a critical role in helping your business achieve the agility it requires to respond and adapt to changing business conditions.
7. Speed and Simplify Training: When utilizing a single software system, user training and adoption is easier and faster. Since employees only have one system to learn and use, as opposed to several different software interfaces, companies save time and effort during the training process.
8. Manage Support: One software system means one software vendor, which prevents multiple vendors from passing software issues off to other software vendors. Also, instead of calling multiple support help desks, there is one support team responsible for addressing all of a company’s software questions or issues.
9. Minimal Maintenance: Overall, since software maintenance is lower, support issues are fewer with a single system. Rather than juggling support issues for numerous systems, a company’s IT department can handle the regular updates and backups for one software system. Single systems also keep network issues to a minimum.
10. Easier Upgrade Process: In addition to minimal maintenance, enterprise wide systems are easier to up-grade, too. Multiple software systems can conflict when one system is updated and no longer works correctly with another system. These differences are eliminated with single system upgrades.

Overall, the benefits of a single software system fulfill the original intentions of ERP as it allows companies to manage their business as simply and efficiently as possible.