In Pharmaceutical industry main focus is producing qualitative and efficient products that are benefiting patients. While many companies are competing with each other with products, innovative technology, ways of manufacturing and supply chain management business processes, one thing unites them all. In one step or another all companies are performing paper “write-ups”.
For many years company’s each product success “formula” was recorded and maintained on paper, yet innovative technology is driving major advancement in paperless world seeking improvements and benefits. While in compliance with regulatory requirements, many organizations are still working with paper-based systems, others have taken new innovation challenge and are successfully (or not so much) operating with paperless system.
What is this success “formula” of the company that can be maintained on paper or electronically? This is traditionally used paper (hard copy) to maintain production/manufacturing batch record (MBR), where all activities are documented according GMP and regulatory requirements and/for compliance. Electronic batch record (EBR) is its prototype that is maintained by software system which came with changes of 21CFR Part 11 in 1997 when FDA began to accept electronic batch record systems.
Let’s take a look on how different two systems are:
It’s obvious that paper-based process takes time, effort and space to manage and to be maintained. It involves risk of human errors with regards of entries on multiple forms and signatures which indicate compliance with many steps needed within manufacturing and process area. This data typically undergo a “first review” on site and then a quality review when batch is completed. Raw materials and finished goods...
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...s used independently providing staff with necessary experience and knowledge through the transition until the electronic batch records is fully employed. Now electronic batch record manufacturing system is operational and the benefits of productivity enhancement, quality improvement and cost reduction can begin to be optimized.
Transition to paperless manufacturing can be challenging. Employee pushback, inadequate or incomplete identification of requirements and system validation can put systems and processes at a higher risk of failure. However, the competitive advantages and benefits offered by the use of Electronic Batch Records in pharmaceutical manufacturing are real, significant, and too well designed to be ignored. When properly implemented and integrated, Electronic Batch Records can help companies increase profitability and maintain a competitive advantage.