How can you recognize a good Electronic Quality Management System Software (eQMS) and what to look out for when shopping for one? Before we dive into it, we need to address what a good eQMS is and what value can it bring to your business.

Electronic Quality Management System (eQMS) software is a digitalized version of a traditional paper-based QMS. The replacement of paper with digital records offers increased effectiveness, reliability, and transparency of processes. The software is sometimes also called an Enterprise Quality Management System which is just an older term for a Electronic Quality Management System.

The most important aspect of any eQMS is of course its specific fit to your business objectives. Each company needs a slightly different solution based on its size, industry, or internal processes. But I guess you already know all that. You already know which processes are inefficient and you know which requirements your Quality Management System needs to fulfill. So how can you find out which eQMS solution will support your QMS processes and make them more effective? Let’s find out.

First, it is important to consider whether you need a validated eQMS. ISO 9001:2015 doesn´t call for software validation. However, companies that need to comply with 21 CFR Part 11, GxP/GAMP or ISO 13485:2016 will require to run a validated eQMS. There are a few possibilities when it comes to the validation of an eQMS.

You can do it yourself, with help from a vendor, or buy a pre-validated product. Pre-validation basically means that the system was tested before use. Unvalidated software can create an additional workload. You will need to manually test the workings of the software and possibly hire personnel that is qualified to do the testing.

Furthermore, if you make changes or adjustments to the eQMS after the initial testing you will have to go through that process again. Pre-validated software takes care of this for you and provides a much faster and hassle-free implementation.

Other than that, there are still a few things to keep in mind when shopping for a good eQMS.

1. The Implementation Process

The most important aspect of switching to a digitalized QMS is time. The time it takes to make an eQMS fully functional typically hinges on the quality of implementation. The key elements of an eQMS implementation typically involve:

  • Set-up and Configuration
  • Training of users
  • Validation
  • Eventual document migration

These parts of the implementation process go hand in hand with the features that your chosen eQMS provides.

Ready-to-Use Solution for Life Science

A Ready-to-use solution means that the software is ready to be used right after purchase or needs very little configuration. It typically involves a set of standardized processes and features that can create value from the get-go. This feature is important because some vendors provide an eQMS that needs more configuration.

These are some of the considerations to take into account when deciding between a Ready-to-use eQMS vs. a Highly Configurable eQMS.

Ready to Use eQMSHighly Configured eQMS
Guaranteed compliance by the vendor – the processes are aligned with regulatory requirements (e.g. 21 CFR Part 11).Compliance not guaranteed – you need to make sure that your eQMS processes are compliant with the regulatory requirements.
Less time and money needed for configuration – key processes and functionality are already configured, based on industry best practices and regulatory requirements.More time and money needed – you or your vendor will be building processes and workflows based on your requirements.
Less time and skills needed for validation – if you buy a pre-validated eQMS, then you don’t need the skills for computer validation and you won’t need to spend time on the validation process.Time and skills for validation needed – you will need to spend time validating and re-validating your eQMS if you make changes to the configuration.
Less flexible – you will be using a more standardized system and will therefore have fewer options for doing a lot of customization.More flexible – you will have more options for configuring and customizing this kind of eQMS.

Some eQMS Systems are built for generic use in many different industries. If you want to use a generic eQMS for specific life science processes it will require manual set-up and appropriation to the industry standards. A Life science eQMS will typically be able to manage SOPs, training, CAPAs, and handle standardized ways for issue handling deviations.

Pre-Made Templates

Templates are standardized forms of specific document types that can make the process of QMS set-up or QMS upgrade easier. One example could be if you are upgrading or updating your current QMS to ISO 13485:2016. In such cases, you can ask your eQMS vendor if they have ISO 13485:2016 QMS-templates readily available that make the process of upgrade and implementation simpler.

Automated migration process

If you have a lot of historic documentation it is a good idea to look for a company that offers automated migration. The process of automated migration transfers all of your documents and records into the eQMS software. It is also important that the company offers proper documentation that proofs and validates the data transfer.

How Long Does Training Take and How Is It Conducted?

When considering your final picks, it might be a good idea to ask into the employee training specifics. Good training can make or break an efficient eQMS and you should make sure that the training will be effective and sufficient. It is also a good idea to ask your vendor if training needs to be paid for separately or if it’s included.

2. Training and Support

Proper training should not be a one-time event. It should include several occasions where your staff receives the information and tests them out in practice with guidance. Overview training followed by hands-on training with immediate feedback is typically the fastest way to familiarize employees with the eQMS software. The final aspect of the training is that it should include training material that allows for easy training of newcomers. Ask about specific outcomes of the employee training and their expected competence level.

The second aspect is support. Your eQMS is implemented and fully functional but something goes wrong, or you need to perform a specific procedure within the software but you don’t remember how. It might be very helpful to have an eQMS provider that has your back in any situation and provides quick and reliable advice on any issue. Ask about specific support options when contacting eQMS providers.

Quality Management System Software Training and Support

3. Validation and Certification

Any eQMS that you consider should have the proper certifications and validation with a team to back it up. These are the essential regulatory requirements for an eQMS solution.

  • FDA 21 CFR Part 11 – Essential regulatory compliance for any company that seeks software which is capable of producing validated electronic signatures, records, timestamps, etc.
  • GxP/GAMP – Computer systems must comply with GxP/GAMP requirements when used in these regulated environments.
  • ISO 27001 – Guidelines for data security. Although not specifically required for regulatory purposes, compliance with this guideline guarantees a high level of security for your data.

Whether your enterprise operates in Medical Device or Pharma industry, these are specific regulations that you need to take into consideration when choosing your quality management system software.

Life Science QMS Certifications and Guidelines

4. Supporting Technology

Finally, the last thing to consider is the technology that the eQMS of your choice stands on.

  • How many aspects of the eQMS are 3rd party and why?
  • How trustworthy and reliable are those 3rd parties?
  • Is the storage space cloud-based or on-premise?
  • Are the 3rd parties properly certified and verified?
  • What kind of maintenance is required of you?

The answers to these questions will provide you with a good overview of eQMS’s technology foundations. Trustworthy 3rd parties are typically an advantage because they are often able to back their services with years of IT experience and hassle-free maintenance. However unreliable 3rd parties can cause lots of problems, from storage issues through dropouts to lost data.

Another thing to consider with 3rd parties is proper certification and validation. Ensure that your eQMS provider works with validated partners when it comes to security and QMS friendly environment.

If the Quality Management System software provider doesn’t use any 3rd parties then ask about the solutions, they are using. Most importantly ask about the maintenance and support when it comes to your data management.

5. Cloud-Based eQMS

Next in line is whether the platform is cloud-based or on-premise. Cloud-based platforms typically involve 3rd party hosting providers who take care of maintenance and data security. On-premise solutions typically require you to create your own server room and hire an IT maintenance team to take care of the support. On-premise solutions are costly, hard to implement, and typically offer no included maintenance.

Cloud-Based Hosting

  • Short implementation time
  • Low initial investment
  • Low additional hardware costs
  • Predictable lifecycle costs
  • Vendor security standards

On-Premise Hosting

  • Longer implementation time
  • Higher initial investment
  • Higher additional hardware costs
  • Unpredictable lifecycle costs
  • Organization’s security standards

Finally, before you buy an eQMS solution ask about maintenance requirements and make sure that you will be responsible for as little maintenance as possible. Cloud-based solutions typically require no maintenance from your side.

Frequently Asked Questions About Choosing eQMS

What Is eQMS?

EQMS is an electronic quality management system. It is software that provides electronic management of your documents and records more effectively than a paper-based QMS.

What Is a QMS Software?

Quality management system software is just a different name for an eQMS.

What Is a Pre-Validated eQMS?

Pre-validated eQMS guarantees that the workings and processes of the software were tested and validated before delivery.

What Is a Ready-to-Use eQMS?

Ready to use eQMS is an out of the box solution that offers a set of standardized processes and features that can create value right after the implementation.

Final Thoughts

When choosing eQMS, a digitalized version of a traditional paper-based QMS it is a good idea to opt for a pre-validated eQMS. Especially if compliance with ISO 13485, 21 CFR Part 11, and/or efficient workflows are your priorities.
It also makes sense to select an electronic Quality Management System Software that is ready to use as it shortens the time spent on the implementation process.

Furthermore, proper training and support provided by the eQMS vendor is an element you must pay close attention to as it makes the implementation process and the day to day work with eQMS easier. Lastly, it is important to note that cloud-based eQMS takes little to no maintenance from your side and typically provides good technological backing.