If you're looking for a quality management system (QMS) specially built for the pharma industry, you're making a smart move.

But don't stop with that requirement. Look for the QMS that will be the most effective for your team. Search for a QMS which fits your company’s stage as a startup, scale-up, or SMB instead of picking a behemoth software built for the multi-national enterprise.

Cloud-based QMS solutions tailored to an industry are increasingly popular. Vertical QMS can provide an advantage, especially in highly regulated industries, by delivering faster time-to-value due to built-in compliance features and workflows.

However, not all pharma QMS solutions are the same. Searching 3rd-party review website Capterra reveals 462 results for “pharma QMS.” If you pick the wrong platform for your team and company, you’ll frustrate your workforce and waste both time and money.

We’ll show you how to find the QMS that will fit your company like a glove. The right solution can streamline your processes and enhance organizational quality, helping you move to the top of your market.

The Most Effective Pharmaceutical Quality Management System Looks Like This

The most effective pharmaceutical quality management system is right-sized for your company’s stage and firmographics to help your organization achieve consistent operations, continuous improvement, and evidence-based decision-making. A QMS should help your organization achieve quality product realization and market approval by supporting pharma compliance with the US FDA current Good Manufacturing Practice (cGMP), ISO 9001:2015, and other relevant regulatory requirements and standards.

Any pharma QMS which is truly built for your vertical should comply with FDA Q10 guidance for pharmaceutical quality systems, including support for:

  • Management oversight via reporting and analytics
  • Quality planning features and workflows
  • Resource management templates and tools
  • Internal communication support via global collaboration features
  • 3rd-party management and oversight tools
  • Continuous improvement support via closed-loop analytics

QMS advertised as an industry-specific solution for pharma offers these features, and in many cases, the quality of the functions can vary significantly. Also, not every pharma company needs these capabilities on the same scale. A pharmaceutical startup in the R&D phase doesn't need the same types of tools for 3rd-party management as a global pharma enterprise with hundreds of suppliers.

To learn more about the must-have features you need to comply with FDA cGMP and other regulatory requirements, check out The 8 Essential Elements of Quality Management for Pharmaceutical Companies.

It's essential to start any software search in a highly regulated industry with a knowledge of your regulatory requirements to avoid purchasing software that could compromise audit results or market approval.

Once you've got the basics down, you can start considering the other aspects of the software to find a solution which drives remarkable results like cost-savings and faster continuous improvement cycles. The most effective pharma QMS is built to comply with regulatory requirements and is right-sized for your company, scalable, and intuitive. The Perfect Quality Assurance Plan for Pharmaceutical Companies

Built for Your Company Size

Pharmaceutical quality management systems are not one-size-fits-all. Smaller and larger organizations have many different requirements and budgets to determine what's practical.

When looking for new pharma eQMS software, it may be tempting to opt for the tool that offers all of the advanced features and capabilities. However, this approach can be a mistake.

Buying a right-sized eQMS software is critical because it ensures your vendor aligns with your organization. There are many reasons to opt for a right-sized system over the most robust system, including cost, complexity, and time-to-value.

An eQMS tool designed for pharmaceutical startups and scale-ups may not offer the same customization potential as a QMS intended for an enterprise, but the right solution fits perfectly. It can allow you to meet compliance requirements and achieve excellent quality while staying within budget and aligning with internal talent resources.

Most importantly, you don't need to pick between having all the features you need to scale and affordability. The right system can scale with your company's growth and help you achieve market approval without having to switch systems or vendors.

Some of the reasons to prioritize a pharma QMS built for your company's size and stage include:

  • Lower costs or monthly subscription or licensing fees
  • More affordable implementation and consulting costs
  • The ability to adopt functionality over time
  • Simpler software administration
  • Better and more personalized vendor relationships
  • More flexible vendor policies

While some stakeholders at your startup may push for a world-class tool used by global pharma giants, you can’t afford to ignore the realities of budget and skills. Advanced functionality and big-name solutions generally carry a massive total cost of ownership (TCO) which isn’t always initially apparent.

You may not be able to take advantage of advanced feature sets since you lack skilled internal developers to configure these features. Most small organizations lack the internal support for a time-consuming, costly software implementation. Right-size your selection with software that can begin delivering value quickly.

Learn how the right QMS drives advantage in The 5 Noticeable Benefits of Implementing a Quality Management System.

It's Scalable OR Customizable

The most effective pharmaceutical quality management systems offer the right balance of flexibility and control. It should be easy and intuitive to remain within the boundaries of pharma regulatory requirements. The software should also provide the right degree of freedom to customize the eQMS to meet your company's needs and profile.

However, too much flexibility isn't always a good thing. It's essential to understand the difference between scalability, customization, and configuration, and to take a realistic look at your capabilities and needs.

The "right" degree of flexibility, once again, varies significantly according to the organization. Smaller companies need some flexibility and extensive scalability to ensure that a system can grow with you. The software should have the ability to add new features as you approach market approval, such as CAPA and customer complaints, which aren't needed in the R&D stage of the product lifecycle.

It should offer secure, cost-effective data storage which scales with your growth. You should have the ability to scale from 10 users to 100 as you expand your workforce. However, small organizations rarely need the same extensive customization capabilities as larger enterprises who want a fully customized, branded user interface.

In our experience, an expectation for complex customization can easily make a mess out of a pharma QMS system. Anything involving custom code creation, either internally or with the support of implementation consultants, should generally be avoided unless you can commit development resources to maintain these configurations.

Customization can quickly cause your implementation and system maintenance costs to skyrocket and complicate system validation. If you're relying on a premises-based or cloud-based customized system, any vendor updates can result in broken functionality or integrations which cause productivity to slow to a halt while you troubleshoot the issues.

Consider the right types of flexibility which won't threaten system functionality or significantly increase ownership costs. Simple customization features like document templates or the ability to update drop-down lists are examples of flexibility that's reasonable to seek out. Customized workflows and other small-scale configurations are well inside existing functionality and unlikely to be broken during system updates.

Startups should focus on pharma QMS that is simple, intuitive, and easy-to-implement. The most effective solution is one which doesn't require much admin time and is easy to scale.

It's Intuitive

If you dig into reviews on websites like Capterra, it's easy to see that not every pharma QMS solution is intuitive. Many systems require internal subject matter experts to manage every aspect of the solution, from training to document management.

In some cases, these functionalities are so complicated that companies are expected to send their workforce to semi-annual training or pay for training each time a module is updated.

Software, which is so complicated that you have to pay for vendor training and ongoing support, can inhibit productivity quickly. Complex software can also increase the chances of errors or non-compliance. If you can't figure out how to build a custom report or integrate the software with a reporting tool, you'll quickly lose oversight.

Intuitive design is actually a key predictor of return on investment (ROI), according to MeasuringU. According to studies, purchasing a system which offers a high degree of usability for the workforce can lead to short-term gains in revenue and long-term gains in customer satisfaction.

When your employees aren't constantly fighting against complicated software, you don't have resistance against technology, and you can focus on developing a quality-driven culture. Other concepts which are closely associated with end-user usability are quality, value, and utility.

Remember that your end-users are the ones who define what's intuitive and not-intuitive. ISO 9241-210, the international standard on human-system interaction, defines user experience as "a person's perceptions and responses that result from use" of a software.

A truly intuitive system isn't just easy for the QA unit to use. It's intuitive for every stakeholder and their needs. Think about how everyone uses the system, and find a QMS which offers accommodation for your busy traveling executives and lab workers with strong mobility and SOP checklists made available at the point of work.

An intuitive QMS can drive many organizational benefits, including:

  • Cost-effective implementation
  • Rapid user adoption
  • Lower ongoing training costs
  • Cost-effective upgrades and scaling

There are several ways to determine whether a system is intuitive and whether usability is the right match for your organization. Ask prospective vendors about case studies at organizations that resemble your company. Was the company able to quickly adopt the solution with minimal training requirements? Did it drive satisfaction across all members of the workforce?

Also, create a cross-functional team for software selection. By allowing QA, training, lab workers, and executives to participate in software demos, you can ensure a pharma QMS provides usability for everyone in the company.

Finding the Most Effective Pharma Quality Management System

If you've read this far, you're probably already convinced that a vertical QMS solution is the right fit for your company.

You're aware that choosing a pharma QMS over a solution built for generic quality management across industries can provide an advantage to your compliance and quality management processes.

However, it's important to remember that not all pharma QMS are built the same.

Digging into user reviews can be a strong gauge of quality, but it's not enough. Adopting "the best" QMS for enterprise pharma at a startup or scaleup can lead to disastrous results, including sky-high implementation costs, unnecessary complexity, and user resistance.

Avoid focusing your search on finding the “right” or “the best” QMS, since the definition of “the best” can vary significantly according to an organization’s size and stage within a single industry.

Asking “what’s the most effective pharma quality management system for my company” is the right question to ask. With knowledge of your software requirements and FDA guidance for eQMS, you can narrow your search to vendors who offer a right-sized, scalable, and intuitive product.

Qualio is an eQMS built for startup and scale-up pharmaceutical companies. We'd love to give your team a demo of our software to see if we'd be a good fit for your organization. Schedule a demo now.

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Published by Robert Fenton August 8, 2019
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