Top Considerations for Compliance Management Tools

Implementing an automated compliance management solution is a mammoth undertaking with high stakes and potentially high returns for those that navigate the process successfully.

Get it right, and you could save thousands of labor hours, avoid millions of dollars in compliance issues, and free up precious resources to accelerate product development. Get it wrong, and you could be left holding the bag with unused shelfware that gets you no closer to your goals.

As you gather your requirements and evaluate solutions, it’s important to look at compliance management tools with a critical eye.

Is the software flexible enough to meet your organization’s needs? Does it come with built-in best practices designed specifically for your industry?

Below we explore these and other questions, looking at the biggest factors customers must consider—and red flags to watch out for.

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Configurability

Given that each organization’s processes are unique, configurability is at the top of the list in any evaluation of compliance management tools. As your processes evolve and you fine-tune them over time, your compliance management solution needs to be able to keep up.

Otherwise, you’ll be stuck trying to align your processes to the software’s limitations—a huge red flag to avoid in the selection process.

Key elements to look for here include:

• Point-and-click capabilities for functions like form design, adding signatures, and creating escalation rules, so you can update the system without re-validation
• Dashboards that can be configured individually, by role, or by group, so everyone has the information they need at their fingertips
• Configurable workflows that you can match to your process and deploy easily without having to make coding changes

Out-of-Box Functionality

Configurability alone is not enough. To accelerate deployment, robust out-of-box functionality is also essential. It’s especially true if you’re looking to align your workflows with industry best practices, for example in processes such as:

• Corrective and preventive action (CAPA)
• Employee training
• Document control
• Risk management

A quality management system (QMS) that comes with built-in root cause analysis tools like 5 Whys, and problem-solving methodologies like 8D, , gives you a pre-configured process you can start using right away to document investigations.

Within this, you can then configure the process, such as creating a rule to launch an 8D investigation anytime you have a repeat issue. Similarly, you can start with a pre-configured CAPA workflow, then build out separate workflows by CAPA source (e.g., supplier issue, customer complaint) with different tasks, routing, and responsibilities.

All-in-One Solution

As you look at compliance management solutions, it’s vital to ask whether the solution provides an entire suite of QMS tools in a single platform.

The problem is that some vendors require you to pay for modules individually as you add them. This is an important red flag to watch out for, as it will ultimately drive up costs and complexity while making it difficult to scale.

QMS deployment often starts with core processes like CAPA, document management, and employee training management. Over time, however, you should be able to seamlessly add more processes as needed, without having to request additional budget.

Built-in Industry Best Practices

Especially for companies in regulated industries, having a QMS with built-in best practices can save significant time and effort.

How much experience does the vendor have in your industry? Do they have demonstrated success helping companies like yours solve the problems you’re facing? These are all critical questions to ask as you go through the process.

Medical device companies, for instance, will benefit from advanced functionality such as the ability to:

• Automatically generate MedWatch reports from investigations and submit them to the FDA with just a few clicks
• Generate complaint records automatically from external systems such as Salesforce to eliminate manual data re-entry
• Leverage pre-configured complaint and investigation workflows built around industry best practices
• Process and manage compliance data to meet U.S., EU, and other regulatory requirements
• Ensure documentation complies with relevant regulations, such as 21 CFR Part 11 audit trail requirements and electronic signatures

Another example would be energy and utility companies, which benefit from a QMS that allows them to:

• Automate completion of Reliability Standard Audit Worksheets (RSAWs) to demonstrate compliance with NERC standards
• Develop comprehensive compliance plans based on requirements, evidence, tasks, and schedules
• Standardize evidence schedules, tasks, and workflows according to NERC requirements, complete with escalation rules and automated approvals to keep the process on track
• Create custom dashboards for monitoring compliance with hundreds of requirements, with the ability to view open vs. completed tasks to identify compliance gaps

Cloud and On-Premise Options

Cloud QMS adoption has experienced a meteoric rise in recent years due to its many advantages over on-premise solutions, including:

• Accessibility: Users can access the QMS from anywhere with an internet connection, a key requirement for manufacturers with multiple sites and remote teams.
• Scalability: A cloud-based QMS can be easily scaled up as your company adds new users or sites.
• Lower IT costs: Cloud solutions reduce infrastructure costs from on-premise servers and hardware, as well as maintenance and labor costs.
• Automatic updates: Having a vendor perform updates ensures you’re always using the most up-to-date version of the software.
• Security: A reputable vendor will be heavily invested in security measures and certifications to keep your data secure, making data in the cloud equally (if not more) secure than data hosted onsite.
• Data backups: Having data stored in the cloud means a catastrophic event won’t affect the availability of your data, eliminating the need for offsite disaster recovery services.

That said, one red flag to watch out for are vendors that only offer cloud-based options. The simple fact is that some companies just prefer to manage data internally, for instance when protected health information is involved or for intellectual property reasons.

Validation Expertise

QMS validation is a labor-intensive and time-consuming process requiring extensive documentation and testing to ensure that software performs as intended. If you’re doing this internally, it can extend implementation by several months compared with leveraging a vendor’s services.

Key considerations when evaluating vendors include:

• Out-of-the-box technical documentation and templates covering the full range of needs for regulatory compliance
• Automated validation to simplify test management of configured solutions, so you can deploy them faster
• Risk-based validation solutions aligned with FDA Computer Software Assurance (CSA) Guidance
• A collaborative process between professional services and validation services, with involvement of validation services starting at the project quote phase
• Independent validation and implementation services teams to eliminate any potential for bias

Integration Capabilities

Another important question to ask as you evaluate compliance management solutions is whether the level of integration meets your organization’s needs. Seamless integration between the compliance management system and external systems such as ERP, PLM, and business intelligence tools is essential to creating a closed-loop process.

Let’s look at an example from a cardiovascular device manufacturer. Before implementing a compliance management system, the company had to dedicate one full-time employee to managing and tracking non-conformance reports. Weekly meetings were necessary to review these reports, with little visibility into the location of parts or who was responsible for managing issues.

By integrating non-conformance management in the QMS with their ERP system, they were able to:

• Define part owners in the ERP
• Assign disposition tasks to users according to pre-defined rules
• Route records for sign-off at each step in the process
• View real-time location of parts and materials

Linking the ERP system to QMS receiving and inspection software further allowed them to:

• Automatically generate QMS receiving and inspection records from the ERP
• Centralize communications between inspectors and engineers without email
• View all pending assignments and real-time updates of records on a single dashboard
• Create non-conformance reports directly from inspection records

 Professional Services and Vendor Support

Beyond the QMS itself, the level of support you can expect to receive from the vendor should also be part of your evaluation. Implementing a compliance management tool is a process, not an event, so you want to make sure you have a partner who will be there to support you throughout.

Ask for references to existing customers, and compare success stories to answer questions such as:

• How committed are they to supporting your industry’s needs with system enhancements and new releases?
• What kind of training, mentoring, and support do they provide?
• How quickly does the team respond when customers have questions?
• Do they solicit customer input to help guide the development of new features?

Conclusion

Companies looking to implement compliance management tools must wade through a diverse landscape of vendors and solutions. Making the right decision can be a catalyst for improved quality and compliance, while going down the wrong path can undermine your goals—and your team’s confidence in your leadership.

Executing a smooth implementation starts with a robust requirements-gathering process, evaluating how well solutions meet your organization’s needs. Configurability is paramount, while robust industry-specific features, built-in best practices, and integration capabilities are also essential to success. Professional services and support ties it all together, paving the way for a smooth deployment from start to finish and beyond.

Read a free case study on how one medical device manufacturer automated its manual quality processes with an enterprise quality management system

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.