eQMS Implementation

eQMS Implementation Process [Checklist]

by | Jun 16, 2021 | QMS

EU MDR Compliant eQMS

Like in any software implementation project, there are many steps necessary to ensure that the eQMS implementation, training, and deployment are a success.

In this article, we will briefly discuss why a life science organization would typically consider implementing an eQMS. Furthermore, possible phases for an eQMS implementation, including a checklist, will be discussed, as well as the main consequences of not having such a system.

Jump to sections that interest you the most:

What is an Electronic Quality Management System (eQMS)?

An Electronic Quality Management System (eQMS) is a digitalized approach to Quality Management Systems (QMS). It is typically defined as a system that documents policies, processes, internal rules, procedures, and other records. This ensures consistent quality of the product/service and high customer satisfaction.

The eQMS is built on top of the traditional QMS methodology but uses software instead of paper. All the documents are therefore digitally stored in the Quality Management Software. This enables you to use automated workflows, take advantage of interlinked subsystems such as Supplier Control, Design Control, Post Market Surveillance, and sign documents electronically instead of using wet signatures.

Reasons for Not Starting Implementation of an eQMS

The reasons why a company would want to implement an eQMS can vary greatly. From our own experience, we believe that the following reasons make life science companies consider implementing an eQMS.

Lack of Validation and Implementation Competencies

Implementation and validation of IT systems is not a core competency at small to medium life science companies. As a result, local project management and procedures for system validation and implementation are lacking.

Projects Never Start Due to Risk

Many projects are too big and risky – and never start.

Therefore, we always recommend starting the implementation of an eQMS in a series of smaller and less risky projects.

At first, you want to complete the smallest project with the biggest impact and the smallest risk.

Lack of Regulatory Understanding

For many years, we also found it difficult to find an electronic system supplier with solid regulatory understanding within the life science industry.

You do not want to put the responsibility of meeting the specific compliance requirements of the eQMS system and its processes on yourself (such as Computer Software Validation and requirements for eSignatures). Ideally, you want to pick a vendor that ensures compliance with the relevant regulations and standards.

Perception of Large Initial Investment

Initial upfront investment in software and a large project are seen as too expensive and risky. This is the reason why many projects tend to be postponed.

Possible Phases for Implementing an eQMS [+Checklist]

If you do not want to watch the video, then continue reading.

Understand, that the most optimal way of approaching an eQMS implementation can be different, depending on the organization’s internal processes and whether you have products on the market or not. The following phases for an eQMS implementation are typical for small to medium-sized companies with a product on the market.

Phase 1 – Digital QMS

In the first phase of an eQMS implementation, we usually recommend carrying out the smallest project with the biggest impact, and the smallest risk. This scope of such a project often includes Document Control and Training Management.

At first, before moving into an electronic system you would typically have to adjust the procedures that you already have.

You would also have to make sure you have a procedure for identity management. Which defines who are the people that you will verify the identity of with an electronic signature.

This includes a contract that people must sign, that when they use the system, they know about the rules, and understand that their signature in the system is equivalent to the handwritten signature.

At this phase, we also often see that organizations implementing an eQMS would want to migrate their whole design control documentation. Experience shows that it often fails…

This is because, during this process, the company would have to change procedures, take all the documentation, “the foundation of the company”. Then, put it into the system they might not fully understand yet.

Phase 2 – Design Control (Applies to Medical Devices or Combination Devices)

When the first implementation phase is completed, users would start getting more familiar with using the system. They would also get a better understanding of the consequences when working with more intensive documentation, which would be implemented in the second phase.

In the second phase, we advise implementing the relevant design control documentation, which often includes the Design History File (DHF) and technical files.

Phase 3 – Suppliers and Equipment

The third phase would usually include the implementation of documentation related to Supplier and possibly Equipment Management. At this point, the company would also set up all the necessary tasks that have to be done at any given time, for example, the re-evaluation of suppliers and upcoming calibration of equipment, etc.

Phase 4 – Post-Market Surveillance Tools

Up next, all the necessary post-market surveillance tools should be implemented. That would include Audit, NCR, CAPA, and Complaint Management.

Note that, such an eQMS implementation path would usually be logical for a small to medium-sized organization with a product on the market. Whereas startups and companies with a product in an early development phase would need to implement port-market surveillance tools in a later stage.

Phase 5 & Phase 6 – Risk Management & Key product-related records

Lastly, you would want to implement tools related to Risk Management, and key product-related records, such as purchase orders, goods receiving, incoming inspection records, etc.

Once again, it is worth noting that the most optimal way of implementing an eQMS may differ. A good rule of thumb is to first focus on implementing the most important processes that your organization performs the most.

Checklist for Implementing an eQMS

These are the possible phases, in a checklist, a small to medium organization would follow when implementing an eQMS.

Phase 1 – Digital QMS

  • Process Changes and Electronic Signatures
  • Template Management
  • Policies and Quality Manual
  • Standard Operating Procedures
  • Work Instructions
  • Learning Management
  • Any Quality Record – in an Electronic Format

Phase 2 – Design Control (Applies to Medical Devices or Combination Devices)

  • Managing Projects
  • Managing Products
  • Electronic Design Master Record (eDMR)
  • Electronic Design History File (eDHF)

Phase 3 – Suppliers and Equipment

  • Supplier Management
  • Equipment Management

Phase 4 – Post-market Surveillance Tools

  • Audit Management
  • Non-Conformance (NCR) Management
  • CAPA Management
  • Complaint Management

Phase 5 – Key Product-Related Records

  • Purchase Orders
  • Goods Receiving
  • Incoming Inspection
  • Manufacturing Order/Batch Master Record (BMR)

Phase 6 – Risk

  • Risk Management

Consequences of Not Having an eQMS

Having discussed the reasons why to implement an eQMS and the possible phases of eQMS implementation, here are some of the main consequences of not having an eQMS.

Loss of Process Efficiency in the Company

  • Document control – without a proper document control solution, authoring, reviewing, approving, versioning, retiring, and archiving all historical versions and records is a manual process.
  • Process automation is not present – for example, access removal to retired versions or capturing acknowledgment for “read and understood” from all relevant stakeholders would be a manual process.
  • Interlinking – making references between records and processes is also a manual process.
  • Search for records is limited/non-existing and the structure of the documentation is one-dimensional.
  • Access to records and archives is local, which is a challenge for companies spread out across different locations.
  • There is a higher risk of creating two parallel worlds – one written in procedures and another in what is practiced. Whereas an eQMS will often enforce a certain process flow and capture all activities on the dates when they occurred.

The Cost of Compliance Is Higher

  • More staff and hours are required on record-keeping.
  • Processes are more time-consuming when without automation.
  • Defining the scope, consequences of changes, and implementing them into the documentation is time-consuming.

The Potential For Human Error Is Higher

  • Manual record-keeping involves manual tasks that someone must do.
  • Lack of overview of pending assignments and the risk of not completing them.
  • Potential of references being wrong.
  • Risk of misplacing records in archives.

Simplify eQMS Implementation with SimplerQMS

SimplerQMS is a pre-validated, cloud-based eQMS, built specifically for the Life Science industry. With SimplerQMS you can manage your regulatory documentation efficiently and in compliance with Life Science regulations and standards.

We use a fast and proven eQMS implementation method which typically takes 5-6 weeks. The implementation process starts with the analysis of your organization’s needs and continues through configuration, training, migration, and an incremental launch of SimplerQMS modules. Our project manager helps to prepare a plan and assign your employees to the key QMS processes.

Keep in mind that all modules – SOP’s, Training, Document Control, DHF/TF, CAPA’s, Deviations, Supplier Management, and more, are included in a one integrated solution. This means that our customers can choose which modules they would want to implement first.

Throughout the implementation process, all users are trained by our staff and receive training certificates after completing the training. In addition, new, and existing users always have access to training videos, guides, and ongoing support from us.

SimplerQMS eQMS Implementation

Wonder how we can help your life science company work more efficiently with documentation and ensure compliance?

We recommend scheduling a demo to see SimplerQMS in action and talk to our experts.

All eQMS Modules in 1 Package