The Life Sciences 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 Life Sciences companies still find themselves buried in paper. Implementing Electronic Batch Records (EBRs) within a Life Sciences tailored solution inevitably leads to an increase in productivity.
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. EBRs 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 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. EBRs 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 EBRs in modern pharmaceutical manufacturing are real, significant, and too compelling to ignore. When properly implemented and integrated with a Life Sciences ERP system, Electronic Batch Records can help companies increase profitability and maintain a competitive advantage.