The eQMS Buyer's Guide

9 questions you need answered

So, you’ve decided to grab the bull by the horns and invest in a brand-new eQMS.

You may have outgrown your existing paper system and be looking to automate and accelerate the way you work.

You may have struggled to streamline your quality management process with Dropbox, One Drive and email. Or you may already have been driven crazy by an expensive, inflexible eQMS everyone in your business hates.

But deciding to commit to a new eQMS may still feel like a risk.

After all, there are many solutions out there, and everybody seems to promise the most intuitive software and the smoothest path to regulatory approval. They can’t all be the best.

So, what’s the difference between them all?

How can you choose the right system to support a scaling life science company?
And how can you make sure you don’t get locked into an expensive mistake?

Here are nine key questions you should ask every vendor to secure the levels of governance you need and the flexibility you want from an eQMS solution.

"The risk with many eQMS is that they are over-complicated and difficult to customize. Life science eQMS often come with one-size-fits-all templates, which demand developers work in particular ways that often aren’t even demanded by the regulation."

Shaun Knights, Callaly

1. How long will it take to get up and running?

One of the most important considerations for those adopting a new eQMS is how long it will take to get existing data into a new system and have everyone in your business use it.

Not every business has a dedicated quality management team ready and waiting to migrate existing documents to a brand new system. So, bear in mind the amount of internal resource you'll need available to configure the solution.

Ideally, with some support from your vendor and a third-party consultant, you should be able to configure and migrate a new system in a matter of days or weeks.

But shifting to some closed-loop quality systems can take months or longer. For example, the Qualio eQMS requires you to set up your quality documentation using their own native document editor rather than the Microsoft tools that most businesses are familiar with.

That represents a lot of effort. Just think - you may already have created hundreds of quality documents in Word or Excel. Have you got the capacity to transcribe their contents into a brand new format?

Also, bear in mind that the more quality documents you convert into a third-party system format, the more difficult it will be to extricate your company from the software if the partnership doesn’t work out.

The right eQMS lets you use everyday tools like Word, Excel, PPT and Visio to build out the digital solution that works for you:

No complicated CAPA and other procedures that you have to adapt to.
No complex configuration with unfamiliar tools.
No changing your process to meet the demands of your vendor’s software.

Medical device developers Coalesce decided to apply for certification against ISO:13485;2016, and had their first audit conducted by BSI within 2 months of going live with their Cognidox eQMS. You can read more about their journey to flawless life science audits here

2. Does it come with the right SOPs and compliance workflows?

A life science eQMS should come pre-loaded with SOPS and workflows to support the specific life science requirements of ISO 13485, FDA QSR, GxP and the ICH Q10 guidelines.

So before you go a step further, just check.

Does it come with all the forms you need to report on non-conformance and Corrective and Preventive Actions (CAPAs)? Will they help you automate the deviation management processes you need in place to meet the regulations?

Does your chosen eQMS let you:

Record quality events
Assess their severity
Auto-notify the right people
Trigger the right investigation process
Conduct root cause analysis
Implement corrective/preventive actions
Review success
Record details of all quality events in an audit trail

3. Is it flexible?

It’s become a cliche. Every eQMS claims to be flexible and scalable. But it’s worth drilling down into what that really means.

Of course, your chosen system should include the robust compliance templates you need for mandatory SOPs such as CAPA, change control, training attestation, complaints, and calibration.

But many eQMS suppliers, in trying to offer an out-of-the-box, closed-loop quality solution, can end up imposing a very prescriptive one-size-fits-all approach.

Popular systems like Greenlight Guru often force you to adopt their pre-defined SOPs, making you deal with non-conformities or CAPAs in particular ways that may not fit the way you want to work.

But every company is different, and you may already have a perfectly serviceable compliance process in place that you just need to replicate in a new eQMS solution.

Are you going to risk wasting time, confusing your workforce, and' over processing’ by adopting a whole new process just to satisfy your software provider?

“With flexible and configurable forms, developers can build out their own unique approach to capturing CAPA, feedback and non-conformances. They can meet the regulation in a way that makes sense to them.”

Fabio Crilli, Avanti Europe

4. Do FDA 21 CFR part 11 compliant signatures come as standard?

FDA 21 CFR part 11 and MHRA’s GXP require changes and approvals to quality documentation in a digital system to be signed off with e-signatures that are:

Unique to individual users
Controlled by administrators to ensure they cannot be misused or falsified
Authenticates every time they are used
Record date/time and ‘meaning’ of every sign-off

Your chosen eQMS should have a fully compliant, closed-loop, e-signature solution built-in at no extra cost.

For external approvals, the system should also offer standard integration with popular solutions such as DocuSign.

"We used to have to wait for a clinician to be present to sign off forms, whereas now everything's just done with the workflows within Cognidox. Signatures are electronic rather than having to have wet ink signatures. We can get documents signed off in minutes rather than days.”

Julie Errington, Clinical Trials Analyst/Coordinator, NCCPG

5. How does the system support design controls?

Life science developers need to phase-gate their design process for ISO 13485 and FDA Part 820 compliance. This means marshalling a lot of complex documentation to support cycles of planning, execution, and review; continually validating deliverables against designs and user requirements.

‘Document holders’ should be available to assemble required documentation for each phase of a development process (including user specs, engineering designs, and validation matrices), triggering approval sequences when the right documents are in place and completed.

With this functionality, when approval is given from all stakeholders, documents should then be formally published to trigger the next phase of development.

Design controls are a vital element of life-science regulation around the world - but don’t forget you should be in control of how you do this. Your chosen solution shouldn't dictate the number of phases you split your design process into. It's up to you to decide the way you want to structure your project. It’s the job of your eQMS software to help you impose the controls you need to streamline and bullet-proof your compliance in a way that works for you.

"We have developed a process using Cognidox which ensures that design controls are established from the outset. With appropriate stage-gates, we employ a rigorous, science-led, Quality by Design (QbD) methodology. It mitigates risks during the later stages of technical transfer to manufacture, and leads to robust, approvable designs.”

David Ahern, CEO, Coalesce

Choose the right tools to structure and automate your technical file compilation

With the right document and design controls in place, your chosen solution should help you template, compile, publish and maintain your EU technical file and FDA Design History File in real-time.

With the right auditing tool, you can give inspectors complete digital access to all required technical documentation, showing the latest, approved version of all your quality documents and a complete history of your decision-making.

6. Is it scalable?

Every eQMS solution seems to be declaring its infinite scalability. But what does that look like in practice?

For those starting out, the most flexible eQMS should allow you to work at a basic level of risk and compliance management as you share initial ideas and designs between your team.

But as your project evolves, you should be able to expand your team and impose required new levels of document and design control without completely overhauling the ‘way you work’ each time.

A scalable eQMS can manage larger volumes of documents, records, and compliance data efficiently, ensuring fast retrieval and processing times regardless of data size.
A scalable eQMS should support future integration with other business systems such as ERP (Enterprise Resource Planning), CRM (Customer Relationship Management), and PLM (Product Lifecycle Management) systems.

This will ensure that your quality management processes can be aligned and integrated with other vital business functions as you scale.

"The real value of an eQMS is when it begins to really underpin what you do and how you work. When this happens, quality stops being a ‘bolt-on’ and becomes simply ‘the way you operate." ”

Chris Hill, Pragmatic Semiconductor

7. How much will it really cost?

Pricing should be transparent and scalable, fitting a range of company sizes and growth stages.

Consideration for small to medium enterprises is important, as high costs can be a significant barrier to adoption.

Most providers will charge you an initial fee and an annual license fee for a certain number of seats. This may seem reasonable until you begin to add in the hidden extras.

Will your annual fee be based on the capitalisation of your company? If so and you’re still in the development stage of your project, you could be charged at the top rate even though you’re unlikely to make money from your product for a number of years.

Will you be charged extra for certain ‘compulsory’ modules?
Will they charge you to import and migrate data into the system?
Will they charge you for training or account management?
Will the system require installation by a consultant for whom you will have to pay extra?

8. Can I get a reference?

Make sure you look online for reviews on Capterra or G2 as you consider your options. For more detailed insight, your vendor should be able to provide references from existing customers, which should give you a more complete picture of what it’s like to work with them.
Ask to speak with a referee from a company of similar size and vertical to yours - and make sure you ask about the support they received during system set up.
It's easy for scaling companies to be neglected by larger software companies, so you’ll want to reassure yourself that support is going to be there when you need it.

9. Can I try before I buy?

A thorough demo should showcase the system's key features, its ease of use, and how it addresses the specific needs of life sciences companies.

But you should also look to trial the software for an extended period before you commit.

Most companies will offer you a pared-down version of their software to play with, usually including some dummy data, but this just won't be enough for a proper evaluation.

It's easy for scaling companies to be neglected by larger software companies, so you’ll want to reassure yourself that support is going to be there when you need it.

A great free trial will offer:

Guided onboarding: Introduction with dedicated support manager
Full feature access: Unrestricted use of all eQMS features, such as document management, compliance tracking, and advanced functionalities
Realistic simulation: Ability to test the system using your own data
Support and assistance: Access to customer support during the trial
Interactive resources: Availability of how-to videos
Enough time: A meaningful amount of time to test the system; not just a week or two

Conclusion

It doesn’t matter whether your organisation has 1000 people or just 10; some eQMS systems still treat every operation the same.

Their document templates and SOPs can insist you embed protocols and approval processes that far outweigh what is justified for your business or required by the regulation.

And their pricing structure can strangle you just at the moment you need to scale up your operations.

Luckily, there is another way.

A LEAN Quality Management System can help you right-size your compliance approach to meet different quality needs. With more flexible document controls, you can build, faster, more efficient ways of working that ensure you meet the regulations while helping accelerate work rates.

With these systems, you can impose the level of control that is ‘just right’ for you, eradicating the burdensome and unnecessary compliance processes that can confuse your teams and slow you down.

But make the wrong decision now - and you could end up with an expensive and inflexible eQMS and a multi-year commitment you can’t break.

So, compare and contrast the solutions on the market carefully. There are many powerful and robust systems available, but they are not all suited to every size and business situation.

In Cognidox, we found a system that was as Lean as we needed it to be. It came with all the controls we needed, including phase gating for design controls and integrated electronic signatures compliant with FDA 21 CFR part 11. But it was also flexible. It was a digital framework for an FDA/ISO-compliant eQMS that we could configure to reflect the way we wanted to work.

Shaun Knights, Callaly

FIRST COLUMN TITLE

Lean eQMS

Document Management

Design Controls

Extranet & Collaboration

Business Management System

SECOND COLUMN TITLE

CAPAs & Non-conformance

e-Signatures

Supplier Management

Training

Change Management

Experience Cognidox

The eQMS Buyer's Guide

9 questions you need answered

1. How long will it take to get up and running?

2. Does it come with the right SOPs and compliance workflows?

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