eQMS: Your Questions, Answered

November 8, 2021

If you work in a regulated industry, you’ve most likely heard the term eQMS or enterprise quality management system. But you may be wondering what is it? Why do I need it? And how do I choose the right system?

What is an eQMS?

eQMS centralizes, standardizes, and streamlines quality content and processes across the value chain, enabling cross-functional communication and collaboration on critical processes. A comprehensive eQMS adopts a broad set of functionalities related to quality management including, GxP, risk, compliance, and auditing. Rather than a stand-alone and disjointed quality system, an eQMS improves workflow by integrating with other applications such as ERP and SCM.

Why do I need an eQMS?

eQMS provides users and regulatory authorities with the assurance that the organization’s operation is reliable – that it maintains a high level of integrity at the functional and structural levels. Especially for companies that outsource aspects of their business or maintain a decentralized location, eQMS can ensure content alignment – keeping all files, information, and communication in sync while recognizing, controlling, and minimizing the risks associated with decentralization.

The benefits that come with an eQMS include:

  • Enhanced profitability -- verifies that each product meets the required quality standards and follows local and national regulations for safety purposes. If customers know they’re getting safe high-quality products, they’re likely to keep coming back to your business and even tell their friends about your company.
  • Ensure compliance – Maintain compliance with the everchanging regulatory landscape.
  • Boost employee efficiency -- promptly allocates particular tasks or roles to employees so they can get to work, accelerating productivity.
  • Fewer risks and better decisions – measures productivity, the quality of your products, and other valuable KPIs so when opportunities arise, you can quickly evaluate and make the right decisions for your company.
  • Manage documents – acts as a digital filing cabinet for your documents, files, and reports so you can easily and rapidly navigate and arrange files to meet your specific needs.
  • Fluid integrations – integrates with other PLM, ERB, and CRM tools to create a single system that streamlines your workflow and provides accurate data within your facility.

How do I choose an eQMS?

When selecting an eQMS, the main objective is that it supports the goal of integrating quality with your company’s objectives. eQMS breaks down silos and connects data across departments, enabling deeper communication, and quicker recognition of errors or potential pitfalls, as well as clear pathways toward remediation.

Here are some steps to consider when selecting an eQMS:

  1. Team approach – create a cross-functional team including quality managers at the executive, corporate, plant, and laboratory levels. The team must understand the goals of the selection process, including the need for an eQMS and how will impact their department/team. Areas to include:
    • Compliance and regulatory
    • Manufacturing operations
    • Packaging, shipping, and logistics
    • Sales and finance
    • Environmental health and safety (EHS)
  1. Selecting the vendor:
    • Compile a list of vendors and submit requests for information or proposals (RFI or RFP). It’s critical that you provide detailed information about your timeline and the custom services your organization needs (e.g., functionality, cost, usability, build requirements, browser-specific or agnostic, etc.).
    • Analyze and compare proposals; determine which ones meet your requirements.
    • Determine how the ones you selected will operate within your current systems (e.g., ERP, CRM, SPC, and others).
    • Ensure that your vendor will provide security levels to meet your business and budgetary needs.
  1. Evaluating the system – vendor demos can provide detailed information about the specific functions and methods of implementation they offer. Here’s what to look for:
    • Flexibility – beware of so-called flexible systems that are limited in their depth of configuration options. Have the vendor configure a few sample workflows and forms for your business process.
    • Web-based vs. web-enabled -- watch out for web-enabled systems that use third-party middleware, which can make accessing data difficult and drive-up costs.
    • Look and feel -- look for a system that can match your company branding without programming, so users are more comfortable and productive with the system.
    • Reporting – avoid systems that use third-party tools for reporting. Make sure your eQMS can generate the reports you need, so you can easily visualize data, identify trends, and transform insight into action.
    • Integration – an eQMS that can integrate multiple systems and departments dramatically improves process excellence. Look for an eQMS that can push and pull data for real-time communication and ask the vendor how the platform can link multiple systems.
    • Scalability -- the ability to scale your eQMS to multiple facilities, suppliers, and even customers is a mission-critical feature. Avoid vendors with complicated workarounds to sync data. Look for a central location for managing sites, admin rights, and processes, where facilities can customize workflows yet corporate can still get the big-picture view of the data that it requires.
    • End User Experience – end user adoption and productivity are key to implementation success. In addition to matching the look and feel as mentioned above, your vendors should understand your business and have a background in your industry.

As the demand for eQMS solutions grows, so does the vendor landscape, complicating decisions over what is the clear choice to ensure a successful implementation and facilitate mission critical quality initiatives.

If you have questions or concerns, or are ready to start the vendor selection process, ProPharma Group and Dot Compliance are here to help. Click here to contact a representative.