Quality

Pharma eQMS

Purpose-built electronic quality management systems (eQMS) like MasterControl's Quality Excellence, allow pharmaceutical quality organizations to automate and streamline processes – always keeping compliance in the forefront.

The best way to build quality into a product is with an effective, connected quality management system (QMS), which serves as the foundation for long-term regulatory compliance and market success. However, not every QMS has the same capabilities and connectivity. A manual or disconnected QMS will slow down quality operations and introduce the possibility of more human error. Find out how an eQMS for pharma like MasterControl's Quality Excellence is better.

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Frequently Asked Questions About Pharma eQMS

What are the key benefits of implementing an eQMS for pharmaceutical companies?

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Quality doesn’t just make good business sense - it’s also a matter of viability and compliance in regulatory environments. Using a purpose-built eQMS for pharma can significantly reduce compliance burdens because it can automates the management of essential quality tasks as well as essential documentation, which forms the basis of any compliant system.

How does an EQMS help pharmaceutical companies maintain compliance with FDA regulations, such as 21 CFR Part 11 and 21 CFR Part 210/211?

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The regulations that relate to any digital quality management solution are outlined in 21 CFR Part 11. Current Good Manufacturing Practices (CGMPs) for all pharmaceutical manufacturers are outlined in 21 CFR Part 210/211. A purpose-built eQMS for pharma is a digital system designed to help pharmaceutical companies more easily comply with CGMP. Essential functionality must include document, training, and quality event management.

How does an eQMS help pharmaceutical companies manage and control documents?

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Pharma eQMS software reduces manual transcription errors and allows you to store essential documents, like standard operating procedures (SOPs), in once place. This means an eQMS is audit-ready all the time. A robust eQMS can automate document workflows (i.e., revision, review, and approval cycles) with e-signature technology and enforce versioning control. It can also support multimedia files, such as photographs and videos.

How can an eQMS help pharmaceutical companies balance product efficacy and innovation?

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The ultimate objective of implementing an eQMS for pharma should be to streamline compliance, which substantiates product safety and efficacy. What’s more exciting about transitioning from manual systems to digital ones is that easily configurable eQMS software is proven to inspire quality personnel to improve and revise processes, which in turn makes it easier to develop new products.

Pharma eQMS Resources

Select all the pharma eQMS resources you’re interested in downloading.

Research Report: The State of Digital Quality Maturity in Pharma and Medtech
Solution Overview: MasterControl Quality Excellence
Ultimate Guide: The Ultimate Guide to Pharmaceutical Quality Management
White Paper: 6 Must-Haves for a Quality Management System (QMS)
Trend Brief: 2024 Pharmaceutical Industry Trends

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How an eQMS for Pharma Supports Quality Maturity

Regulators are holding you accountable for product safety and efficacy. You can hold yourself accountable by evaluating your level of quality management maturity (QMM).

An eQMS for pharma supports quality management maturity.

The FDA and international standards organizations are promoting the use of advanced technology and claiming it is essential to mature quality management practices. There seems to be a direct correlation between digital maturity and QMM, which the FDA plans on evaluating with an optional rating system in the future. It is becoming clear that pharma companies must adopt digital quality management systems to remain viable.
Quality is closely incorporated into regulations and standards. Likewise, regulations and standards are embedded into effective quality management. Because a robust eQMS for pharma is responsive with real-time features and data, it can go a long way to help companies keep pace with evolving quality management regulations and proving it.
An eQMS for pharma accelerates digital maturity.

It’s nice to say you’ll be digital in five years, but what does that look like and how do you get there? What about your competitors that are already using connected or intelligent eQMS software? Pharmaceutical companies know that to keep up with the competition it’s imperative to undergo digital transformation sooner than later. The key is to start and progressively continue toward greater digital maturity.
Implementing an eQMS for pharms is a critical step in the journey. If you make it the first one, you can achieve the Industry 4.0 imperatives of digitization, automation, and integration at the same time. Then you’ll be well prepared to implement emergent technologies as they become available. You won’t be trying to catch up to your competitors; they’ll be trying to catch up with you.
An eQMS for pharma enables patient centricity.

Patient centricity is a relatively recent concept that only mature quality organizations can incorporate, but one that may dictate future relevance. It requires companies to take an enterprise-wide approach to products, processes, and partnerships that place the patient at the center of operations. Doing so yields dividends, including in-depth product knowledge and increased customer loyalty.
Using a pharma digital quality management system may be the most important step in establishing a patient-centric ecosystem – next to finding ways to connect dynamically with patient experiences and needs through an Internet of Things (IoT) network. Look to an eQMS enabled with cloud, integration, and intelligent technology here.
An eQMS for pharma supports precision products.

More personalized medicines and therapeutics are cropping up every day. The future of pharma will be paved with precision products and the companies that can evolve to develop them. The good news is that even though these products are more complex, the eQMS software you need to develop and produce them doesn’t have to be. Configurable eQMS solutions are ideal in this context.
Additionally, best-of-breed eQMS for pharma solutions now feature embedded intelligent technology like artificial intelligence (AI). This is crucial to accommodate the evolving specificity of personalized products, alongside more complex time constraints and workflows.
An eQMS for pharma allows for scalability and growth.

A company’s measure of quality maturity might include the size of its customer base or the scale of its operations. Because eQMS software automates quality management processes and stores supporting documentation electronically, it doesn’t require additional storage, administrative offices, or even personnel before you can expand.
With an integrated solution, you can even take a modular approach and tackle one area of quality management at a time (i.e., start with documents and training modules and then move on to quality event management (QEM)). After you implement and establish an eQMS for pharma at one site, you can leverage integration and cloud-based technology to take it to another, and another.

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Pharma eQMS