Process ERP Software is the Solution for Both Efficient Control and Regulatory Compliance Needs of Pharmaceutical Manufacturers

Share

Pharma_ERP

Pharma Industry is becoming a challenge – why?
Increasingly demanding healthcare agenda is becoming a challenge for the Pharmaceutical industry to remain competitive as well as efficient and profitable. They have to constantly and smoothly re-engineer themselves to meet the global need for innovative, cost-effective medicines, high quality & effective products, data integrity and changing regulatory requirements.

These regulatory requirements arise from the aspects critical to patients. New concepts are emerging to redefine how drug manufacturing can be done better. Examples include science-based risk management approach, which focuses on product and process understanding and the application of Quality by Design concepts.

How are they meeting the challenges?
To meet these challenges Pharmaceutical industry has shifted its focus from primitive systems, take care of only Accounting part, or some basic planning software. This limits their overall efficiency and effectiveness as a manufacturer. What they need is a more integrated approach to have better control over their business processes. In such an environment, it is unsurprising that Enterprise Resources Planning (ERP) systems have generated interest from small & medium-sized pharmaceutical companies.

How full featured ERPs, designed for Process manufacturing like BatchMaster ERP, help?
ERP is a planning system that helps companies respond to the current market environment and optimizes their processes. Data that was once captured, replicated, maintained and reported in many different systems can now reside in one system. This helps the firm to better respond to customer demand. It brings about higher sales, better customer service, lower inventories, and lower cost of operation.

Further, Process ERP system has the ability to address a range of business processes critical to Process Manufacturing, like formula secrecy maintenance, Sample development & product costing, handling multistage intermediates, the end to end inventory lot tracking, regulatory requirements like FDA, cGMP etc. in an integrated fashion. This makes the business processes simpler & the life of employees better. Process ERP not only helps them to comply with their obligatory regulatory requirements but also provide them many other business benefits. Because of the capacity of ERP systems to address both information needs as well as regulatory requirements of all departments and functions across a company, they have progressively become the reference solution for Life Science companies.

The fact, that ERPs are designed and manufactured according to GAMP guidelines and with QMS based on life cycle model. This helps in its smooth implementation following the same guiding GAMP principles. The implementation is based on a complete life cycle approach as part of a Quality Management System (QMS), from concept to retirement and scalable approach to achieve and maintain GxP compliance.

Wrapping Up

The key driver behind the design of a process manufacturing ERP is to ensure business control, product quality and data integrity, enabling manufacturers to deliver safe & high-quality drugs at a competitive price. This has increased realization amongst the Pharma manufacturers that process ERP is an ideal solution software for them.