Before exploring the factors for selecting enterprise quality management software for pharma companies, let us see why you need an EQMS. Electronic quality management software (EQMS) is a system that enhances the quality of various processes and ensures regulatory compliance. It reduces the risk of quality process failures lowering overall costs and making their organizational processes more regulatory compliant.
Pharma companies should select the QMS based on the capability to provide a faster return on investment. It must ensure alignment with the business processes, documents, and company policies. There are multiple factors to consider while selecting the right vendor for your QMS since correctly working software is not the only achievement. Flexibility, Integration, Implementation, and support are also very crucial in decision-making.
Let us understand the top 5 factors to consider while evaluating your EQMS vendor.
Regulatory Compliant
With the rapidly evolving regulations in the Pharma & Life Science industry, cracking the complexity of regulatory compliance is a challenge. The software should satisfy the regulatory compliance and statutory standards of the products & services. Not to mention, fulfilling customer requirements is a must. The EQMS software will have to comply with all the regulatory standards like 21 CFR Part 11, EU Annex 11, GMP, ISO and many more.
Configuration & Integration
The software should be able to adapt to the existing business protocols and processes. Flexibility should be there to manage changing business trends for Pharma & Life Science sectors. The EQMS software will have configuration tools like Workflows, Validation, Business algorithms and reporting. The EQMS should be scalable both vertically and horizontally.
Brand History
While selecting the QMS software for pharma, gather knowledge on the previous rollouts they have implemented. Doing this helps make sure that the vendor is qualified and validated. The legacy, experience and technological capabilities will make a big difference in terms of the quality of the product.
Backup & Data Security
Nowadays, with the cloud going big, every company needs to store data on it. Hence, securing that data becomes mandatory. The risk of data loss can put the company in a chaotic scenario. To avoid that, vendors provide data backup services as well.
User-Friendly (UI/UX)
Asking someone to adapt and get used to working on a new automation technology software requires a change in the approach to work. Do a dry run of the software with a select few features and see if the software is well-designed or not.
Sometimes, following these factors also ends you selecting the wrong vendor for your business needs. Edge out the quality management issues with QEdge – A Holistic enterprise quality management software for Pharma & Life Science Sectors.
Experience a Digital Transformation journey with a trusted automation and digitization partner. To start, email us at sarjen@sarjen.com or visit qedge.sarjen.com
Sarjen System is serving the Pharma & Life Science industry for the last 25 years. With an experience in the industry & knowledge, we keep updating our products regularly so that they are regulatory compliant at any given point. All our products are greenfield products and technologically updated as per requirements. Explore QEdge – your 360-degree quality management software to edge the hassles and be ready for audits anytime.