6 Must-Haves for a Quality Management System (QMS)

In regulated environments, such as those under the jurisdiction of the U.S. Food and Drug Administration (FDA) and/or International Organization for Standardization (ISO), quality is included in regulations and standards. So, quality isn’t just good business, but also a matter of compliance and requires a good quality management system (QMS).

The FDA states that “quality should be built into the product, and testing alone cannot be relied on to ensure product quality.” The ISO 9000 series of standards also points out the importance of making quality an integral part of a manufacturer’s daily operations. In today’s world, doing this requires automated manufacturing and digital systems.

6 Must-Haves of a QMS

The best way to build quality into a product is with an effective, connected digital QMS. This is the foundation for long-term regulatory compliance and market success. However, not every QMS has the same capabilities and connectivity. A QMS that isn’t connected to other areas of the company and requires using rigid processes with little flexibility slows down quality processes and introduces the possibility of more human error.

Life sciences companies need a QMS that provides functionality across all areas of quality. This includes document control, training management, quality event management (such as corrective action/preventive action [CAPA] management), etc. It also needs to integrate with other systems. The ideal QMS should let you easily configure it to meet your processes, instead of forcing you to change your processes to meet the QMS. A QMS that isn’t flexible will always slow down processes and keep you from making changes to become more efficient. To find that QMS, look for a system that does the following.

1. Enables Automation

Even in today’s business world, where technology is everywhere, many companies in regulated industries still rely on paper-based or hybrid quality systems. While a paper-based system can be compliant, it requires more time and effort to maintain that compliant state. Every task that is automated in a QMS has to be done manually when dealing with paper. That includes routing documents for signatures, updating standard operating procedures (SOPs), and locating documents for an audit or inspection.

Quality systems are complex, but manageable with a QMS that automates all quality-related tasks for documents and forms, including:

• Routing.
• Tracking.
• Escalation.
• Review.
• Approval.

This applies to SOPs, training records, electronic production records, and anything else that requires review and approval. Since these documents are all stored in the same system, a company can always be prepared for an audit with the most up-to-date version of each document, fully automated change control, and an electronic signature trail.

Just because a system is automated doesn’t mean it can’t be flexible. Highly configurable systems let you automate which paths a quality event management investigation takes based on the data provided. Due to recent advances in software validation you can make these changes quickly and then validate them to ensure you’re operating in a validated state.

2. Connects All Areas of Quality Management

If putting a dollar value on quality is difficult, breaking the concept of quality into sections is even more challenging. Consider the example of a defective medical device, in which a new glucose monitor shows incorrect readings during testing. An investigation of this product would cover the whole product life cycle. The manufacturer would investigate the root cause of the problem through its CAPA management process.

In this example, what if the CAPA investigation showed a weakness in product design? A design change would be initiated and managed through the change control process. When the change is approved and successfully tested (and proven safe), this has to be documented. All updates in the documents for this product would be managed through the document control process. Then, employees need to be trained on those changes, which is part of the training control process. From this perspective, it is virtually impossible to manage each aspect of quality as a separate process.

Since all areas of quality are connected, you need a fully connected QMS for closed-loop quality management. This QMS would let you document your change control and gather electronic signatures for approval. When you update related SOPs, a QMS should automatically send out training tasks to employees. You can also control which employees receive that training. This helps ensure the corrective action is fully carried out without letting anything fall through the cracks.

With a connected QMS, users can enter a quality event, investigate it, determine corrective action, approve changes to or new documents, and send out training automatically all in the QMS. This makes it very easy to show your process during an audit and to quickly pull all documentation related to the original issue and how it was resolved.

3. Provides Robust Analytics and Reporting Capabilities

Today’s manufacturing environment is competitive and fast paced. To get ahead, businesses must not only ensure product quality, but also have insight into all quality processes. Those in regulated environments need tools to help them see trends and understand quality issues to proactively solve problems. Their ability to adapt to changes and problems quickly can be the difference between a simple CAPA or a product recall.

Enterprise systems hold all the data you need to make smart decisions for quality and manufacturing but turning that into predictive quality analytics is difficult. Collecting and analyzing data takes time, especially if you do it manually. Even if you’re working with a digital system, Excel data dumps are a fact of life. It doesn’t have to be that way, though. With complete quality data that is always up to date, all the information you need is at your fingertips.

An advanced QMS offers features to track, trend, and report on the data within the QMS. You can use the out-of-the-box reports in the QMS, but also easily create your own with intuitive tools. The level of detail is flexible, allowing you to see a broad overview or drill down into the details of the data. Forward-thinking vendors will offer predictive quality analytics. An example of this is to tell you if an employee is going to be overdue on training. Predictive quality analytics and closed-loop quality ultimately improve your bottom line.

90% reduction in investigation cycle time for deviations and nonconformances when companies use advanced analytics.

4. Flexible and Scalable

Automating a quality system is a major endeavor in terms of time, effort, and cost. Rather than be forced to revamp their system often, businesses choosing a QMS should consider how the system would support future growth at three levels:

1. Users (by the dozens, hundreds, or thousands).
2. Business units (domestic and/or overseas).
3. Operations (new products and services).

The system must be able to adapt to changes in the market and in the regulatory environment.

When looking for a QMS, consider how your company may change over time. As you grow, can the QMS keep up? For example, can you begin using the product with limited functionality and then expand your use? Can you go live at a single site and then roll out to others? If you’re part of a large business that has multiple other enterprise systems, make sure the QMS can integrate with those systems. Flexibility is equally as important. A difficult part of user adoption is when you need users to change how they do things to fit the system. That’s why it’s easier to find a QMS that can be changed to fit your current processes. This can be done through custom code, but that makes it difficult to make any changes without heavy services fees. A no-code QMS that can be configured to match your processes lets you design your own workflows. Then you can quickly make changes whenever needed without compromising software validation.

5. Puts You in an Audit-Ready State

A big part of passing an audit is finding documents to show to the auditor. When these are kept in filing cabinets or saved on one person’s computer, finding the document is a hassle. With a connected QMS, finding documents is easy. You can quickly search and know that the version you’re looking at is the most recent one. The needed electronic signatures and audit trail are automatically logged and easily demonstrated to an auditor.

Some of these documents are training records. Despite training requirements, many companies fail at keeping employees trained and keeping track of the records. Not surprisingly, training is among the top reasons for receiving an FDA Form 483. There are two reasons for this. One is that a lack of efficiency, visibility, and connectedness means employees can’t perform according to industry standards. The second is that, even when employees are trained, it is difficult to find the paperwork that proves they were trained. A training management system alone can’t solve these problems. But with a QMS that has automated assignments, monitoring, and verifying of training tasks, you can ensure training happens and that you can easily find the records needed during an audit.

UCSF Health experienced a 50% improvement in training cycles after implementing MasterControl Quality Excellence.

6. Makes Continuous Software Validation a Strategy for Staying Compliant

Companies doing business in FDA-regulated industries must have documented evidence that their computer systems consistently perform as expected, a practice known as software validation. The FDA also requires companies to be in a constant state of validation, which generally means they must re-validate every time they upgrade or change their systems. In some companies, validation requires months to complete and produces stacks of paperwork to prove validation occurred.

MasterControl is a trailblazer in simplifying and expediting software validation for our customers. The patented Validation Excellence Tool (VxT)TM uses a risk- based approach to validate, which is what the FDA itself suggests. VxT lets users assess the risk to their business based on how they use the software. By relying on MasterControl documentation and only doing additional testing for high-risk features, validation can be done in hours or even minutes. With more flexible, configurable software, validation needs to continue to evolve. MasterControl is again innovating with the patented Validation on Demand (VoD)TM. VoD lets users perform next-generation, automated validation testing targeted to their unique use cases and workflows.

Average upgrade validation time 45 for MasterControl VxT users.