Top 10 Factors To Consider for Selecting QMS Software for Pharma Industry

The Quality Management System (QMS) plays a crucial role in the pharmaceutical industry by helping manufacturers ensure their products and processes meet quality standards and customer expectations effectively. Its robust modules automate and streamline various quality-related activities, including document control, audit management, CAPA, complaint management, and risk management.

However, despite its benefits, many manufacturers still rely on paper-based or excel spreadsheet systems. This exposes them to numerous risks and consumes considerable time in manual tracking and data recording.

In the pharmaceutical business, using a manual or spreadsheet-based approach has even bigger consequences. This sector has its own challenges, like managing a lot of documents and compliance requirements, worries about data security and accuracy, and dealing with the complexities of conducting quality tests and inspections. Overseeing them through manual methods can be chaotic and error-prone. And thus, adopting a Pharma Quality Management Software is the way out.

While there are various QMS in Pharma providers, it is essential to acknowledge that no one-size-fits-all solution exists. Companies should avoid trying to fit their requirements into a predefined QMS software; instead, they must select software that precisely aligns with their needs.

The key lies in choosing a Pharma QMS Software that is tailor-made to meet their specific demands and challenges effectively.

Look for the below-mentioned features and capabilities before considering a QMS Software for Pharmaceutical Industry-

1. Compliance with Regulatory Standards- The QMS you select, must align with global regulatory standards such as GMP, GLP, GCP, FDA 21 CFR Part 11, etc. to facilitate audits.

2. Document Control and Management- Robust document management capabilities, including version control, approval workflows, and electronic signatures, are unnegotiable in a QMS.

3. Change Management- A QMS software should support efficient change control processes, right from approval till proper implementation of the required changes.

4. Training Management- This feature automates company-wide training activities, right from scheduling, managing, execute training programs along with maintaining employee evaluations.

5. Corrective and Preventive Action (CAPA) Management- The software should have a comprehensive CAPA module to facilitate systematic problem-solving, root cause analysis, and effective corrective actions

6. Non-conformance Management- The QMS software should possess the capability of identifying, recording, and tracking all the present non-conformances and prevent their recurrence.

7. Risk Management- This feature aids in identifying and assessing risks associated with product quality. That’s why this feature needs to be there in your QMS software.

8. Audit Management- This feature automates the complex task of scheduling, conducting, and tracking internal and externa audits, and thus is a must-have for a regulated industry like pharma.

9. Usability and Intuitiveness- If the software is hard to understand and takes many efforts of a user to navigate through the functionalities, then it will be of no use. You must ensure your QMS has a user-friendly interface.

10. Data Security- Data security through role-based access, encryptions, etc, approval workflows, data backup and recovery, and such features should not be compromised to

If you are looking for such a Pharmaceutical QMS Software that has all these capabilities and can execute quality control operations responsibly yet efficiently, then choose BM QualityMaster.

Get in touch with our experts to schedule a demo today.