Not Every eQMS Is Equal

Electronic quality management systems (eQMS) designed for pharma with compliance in mind.

Maintaining disconnected quality management systems is no longer adequate to compete in the modern world of pharma. Digital quality management systems (QMS), also known as electronic quality management systems (eQMS), are replacing manual ones and allowing manufacturers to outpace their competitors who delay digitisation in the age of Industry 4.0.

Efficient digital quality management is built upon eQMS software, which offers features that can be flexibly configured to automate both compliance efforts and patient-centric design – two keys to success. Read this industry brief to find out how to evaluate different eQMS solutions and how the right solution can:

Enable automation to streamline compliance.
Connect enterprise quality management operations and centralise essential data.
Provide robust reporting and analytics.
Support process flexibility and scale for growth.

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 organisations 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 digitisation, 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 organisations 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 personalised 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 personalised 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.