Part 3 of a three-part quality automation blog series
We live in a time of rapid advancement in technology. There’s no shortage of “smart” things, from phones and watches to virtual assistants and autonomous vehicles. Life science companies, manufacturers, and other regulated companies are at the forefront of innovation. Unfortunately, many of them fail to realize the full benefits of automated EQMS implementation to streamline the quality value chain.
Even when organizations decide to automate their paper-based processes, there is still room for failure. Primarily, failing to optimize usage of their enterprise quality management system (EQMS). For example, using different electronic tools that are unconnected, or working with an electronic system that’s inadequate for compliance purposes. If you’re installing EQMS software to automate a manual system or improving an existing EQMS, you’ll undergo three major stages.
This is the third installment of a three-part blog series on the importance of an EQMS for medical device and diagnostics, pharmaceutical, biotechnology, and manufacturing companies. In this article, we’ll discuss the phases of an EQMS project. These phases include pre-implementation (planning and system design), implementation (including validation), and maintenance. We’ll tackle common pitfalls and essential strategies for overcoming them.
EQMS Software Phase 1: Pre-Implementation Planning
Organizations often know their QMS is inefficient, inadequate or ineffective, but they don’t recognize the underlying problems. They have a list of what they need and want, but find it difficult to convince senior management to invest in a better system.
1: Audit your internal needs.
Start by performing an audit of your system. To begin, take an inventory of the strengths and weaknesses of each quality process (document control, training, change control, CAPA, etc.). If you can, measure the performance of your current system in terms of how many man-hours it takes to run each quality process and the corresponding dollar cost.
- Identify your organization’s needs: List your quality management needs based on your audit results.
- Define your objectives: Set a concrete policy defining your objectives (i.e., accelerating FDA and other regulatory submissions, increasing efficiency, etc.).
- Write your proposal: Make a case for an improved system based on your audit results and objectives. You can propose a new EQMS to replace the manual system or an integration of unconnected electronic systems for a better EQMS.
2: Secure executive sponsorship.
You’ll need to sell your EQMS plan to C-level executives. Without their buy-in, it will be impossible to get the support of the rank and file and for the project to succeed. Once you have senior management’s buy-in, engage the other departments. Choose a project “champion” from each department for cross-functional collaboration.
3: Select the right implementation team.
You want the right number of people on your team. First, you’ll need a project manager to document system requirements and manage the budget and timelines, in addition to technologists (from your IT department or consultants) tasked with system design, configuration, integration, and deployment. Next, assign system users as representatives who will be running the EQMS and quality processes on a daily basis.
4: Keep the entire organization well-informed.
EQMS implementation is a big change. Prepare your users for the change by keeping them informed throughout the project. For example, contribute to an internal online newsletter or create a chat forum to impart timely information.
Strategies for Quality System Design
Many organizations fail during this phase because they either have too much or too little input. On the one hand, they may spend too much time trying to accommodate every user’s wish list. On the other hand, they may listen only to certain users and miss major needs. Some companies fail when they stubbornly replicate their paper-based processes instead of leveraging the new system’s capabilities.
5: Document your requirements.
Assess your system and user needs, as well as regulatory requirements. Document your needs, making a distinction between priorities and secondary needs.
6: Write the technical and functional specifications.
Document existing quality processes and process owners. Define user roles and responsibilities. Create standardized terminology and definitions for your EQMS.
7: Choose the right software.
Choose a solution that meets your current needs and addresses future needs (i.e., scalability to accommodate company growth and flexibility to adapt to regulatory changes).
On-premise versus cloud: An on-premise EQMS resides within a company’s location. It requires a higher long-term investment for hardware, software, and IT staff. Generally, an on-premise system is defined by an organization’s GRC policies for IT assets. On the other hand, a cloud-based EQMS entails a lower cost because it doesn’t require hardware, and multiple companies share the same instance of software.
Out-of-the-box (“OOTB”) vs. configurable vs. custom: Pre-configured, out-of-the-box software solutions are ideal for startups and small businesses that have standard compliance requirements. OOTB can be deployed immediately at a lower cost. Unfortunately, many EQMS applications with good OOTB functionality may present issues if a business experiences growth or change. Too often, the cost of customizing workflows or integrating enterprise applications becomes relatively high.
For many life science and other regulated companies, a configurable EQMS offers the flexibility to address specific needs. Choose a configurable system that provides pre-configured features for basic processes with a high level of configurability for unique processes. Companies with strict compliance eeds should consider a feature-rich, configurable EQMS that can change and adapt along with business needs and integration requirements.
8: Prepare for validation.
If you’re regulated by the FDA, you’re going to need to conduct system software validation. Choose a provider you can partner with for validation throughout the software lifecycle.
EQMS Software Phase 2: Implementation
Even with the best planning and system design, some projects fail due to external factors. Organizational priorities change or project funding is withdrawn due to budget issues. Other projects fail at this phase because of user resistance due to poor communication or inadequate training.
9: Set prioritized and realistic milestones.
The needs and goals you’ve identified during the planning phase will help you set realistic project milestones. Sticking to your milestones as much as possible will help you complete the project on time and on budget.
10: Deploy the new (or improved) EQMS.
Make sure the new system is configured to your specifications. If you’re using disparate electronic systems (PLM, ERP, CRM, LMS, etc.), this is the time to integrate them under the new EQMS. Migration of existing data to the new system will also take place at this point.
- Deploy in the right order: Automate your document control, training management, CAPA, and other quality processes in the right order. Document control is typically the foundation of all documents-based tasks and processes, so start with it.
- Train users: Train your users at the start of this phase. Their familiarity with the system is crucial to gain their acceptance.
- Validate your system: The FDA advocates risk-based validation. This approach helps minimize the impact that issues may have by identifying and prioritizing which issues pose the greatest risk to product quality.
EQMS Software Phase 3: Maintenance
It’s easy to become complacent after implementation. Many companies fail to optimize their EQMS because they cling to the original policies and processes even after new issues and needs arise. Also, resistance to software upgrades could jeopardize the security, efficiency, and effectiveness of your EQMS.
11: Conduct periodic internal audits.
Periodic assessment of your quality processes will let you know if your EQMS still meets your compliance and quality needs. Use metrics to measure the system’s performance, including ROI and key performance indicators (KPIs).
12: Conduct regular software patches and upgrades.
Application upgrades, security patches, and ongoing system maintenance will help keep your EQMS humming. Embrace them as a best practice. If your EQMS is in the cloud, your vendor manages the hardware, and will advise you of updates, fixes, and upgrades. If your EQMS is on-premise, make sure your administrator is responsible for confirming that all updates, patching, etc., are performed on a timely basis to minimize the risk of downtime.
Quality management is never “done”; it’s a dynamic process in and of itself. Instill this kind of mindset among your users, senior management, and other stakeholders. Let them understand that quality needs to be the responsibility of the entire organization, not just the quality team. Use your EQMS as a tool for promoting continuous improvement and a company culture in which everyone practices quality in all their tasks.
Blog 1 of the 3-Part Series: 5 Reasons Why an Electronic Quality Management System is Imperative
Blog 2 of the 3-Part Series: Making the Business Case for an Electronic Quality Management System
About the Author
Sal Lucido is Co-Founder and Executive Vice President AssurX. Sal is an unequivocal product evangelist and an expert in the area of quality process automation. He holds a broad array of responsibilities, ranging from overseeing strategic plans and operational improvements to managing tactical alliances.