e-QMS Software Selection for Entrepreneurs
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Selecting an electronic Quality Management (“e-QMS”) Software can seem quite daunting. Especially, if you are an entrepreneur with no prior experience with such systems. Making the wrong decision can be costly in time and money.

Not to worry!. Let’s go through some basic information that will help you make an informed decision.

So, let’s start with – What is an e-QMS Software?
In all Medical Device manufacturing facilities, numerous procedures are required for FDA compliance. These procedures need to be created, reviewed, and approved. When revisions are needed, the entire cycle begins again.

Next, there are a number of records that are constantly generated to demonstrate compliance to these procedures. For example – Training Records, Manufacturing and Testing Records, Calibration Records, Preventive Maintenance Records, Distribution Records, and so on.

The number of records increases exponentially with the scale of the manufacturing operation. Imagine the number of training records for a 10 person R&D shop and a 5,000 person sterile device manufacturing facility.

As the number of procedures and records increase, usage of “pen and paper” to manage them becomes impossible. At some point during a company’s growth, implementation of a software solution becomes imperative.

Next, let’s discuss – What are the capabilities of e-QMS software?

Most e-QMS software can manage FDA requirements relating to:

  1. Document and Records – Ability to review, approve, store, search, and revise procedures and records.
  2. Training – Ability to display approved procedures, and capture completion of “read and understand” training.
  3. Audits – Ability to schedule, execute, and report internal and supplier audits.
  4. Equipment – Ability to schedule, execute, and report calibrations and preventive maintenance activities.
  5. Complaints – Ability to capture, evaluate, and report user or patient feedback and associated remedial actions and responses.
  6. CAPA – Ability to capture and evaluate issues, and actions take to prevent their occurrence or recurrence.
  7. Design Control – Ability to capture and link user needs, functional requirements, detailed specifications, risks, and verification/validation tests.

e-QMS Software can be SaaS, On-Premise, or Hosted. You can buy the various “modules” a la carte or as an all-inclusive package. Yearly maintenance fees are typical. Licensing can be on a named user basis or concurrent.

System Administrator training is typically required and is delivered remotely or on-site at the vendor’s location. Vendors can help with initial configuration of the system, validation activities, and also provide training videos, user manuals and procedures.

Finally, let’s discuss – How do you select the best solution?

Not everyone needs a e-QMS system. For startups developing relatively simple devices, using a paper-based system combined with a cloud storage system will suffice (e.g. Google Drive, DropBox, OneDrive). Same for “Virtual Companies” that outsource development and/or manufacturing.

For a typical medical device start-up – 20 employees is about the point you need to seriously consider getting an e-QMS software. At this stage, you should get the following modules at a minimum:

  1. Documents and Records
  2. Training
  3. Design Controls

As you scale-up and transition into commercial operations, you will need to get additional modules. You may need to migrate to a different system with more sophisticated capabilities.

Vital Compliance has helped many clients determine if they need an e-QMS system or not, and then helped select the best option for those that need it. Feel free to contact us if you have any questions.

Free Tool for DIY’ers – The attached checklist facilitates detailed review and comparison of various e-QMS solutions, so you can select the best overall option and also includes our recommendation for small businesses. We have no relationship with the recommended vendor and do not get any sales commission from them.