QReview Q&A
with Rebecca Fuller

FDA Regulatory Compliance Consulting meeting at a company - QualityHub

What is QReview?

In this post, you’ll hear from our newest Consulting Director, Rebecca Fuller. 

With over 30 years of industry experience, we wanted to get her thoughts on our remote review service — QReview. 

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Q:

How did QReview come about?

A:

QReview was a concept that our team actually started discussing more than three years ago.  While it was the Covid-19 situation that encouraged us to move forward with our plans to build the systems we needed to launch this new remote, subscription-based consulting option, we have long seen the value and potential of a subscription service model to provide on-demand consulting and technical support to meet our clients ad hoc needs for this.  Of course, its value is even more apparent given the Covid-19 restrictions and the “work from home” approach that many companies are now supporting.  

Our QualityHub team feels strongly that there needed to be a means to accommodate the intermittent needs of our clients to get advice on a technical, quality or regulatory topic or get an independent expert’s review of a document or group of records, without having to go through the whole process of developing a unique Statement of Work, service agreements, and purchase orders.  And we wanted our services to be readily accessible across a company with quick responses from our cadre of great subject matter experts. 

Q:

Who is the target audience for QReview?

A:

The subscriber or subscription administrator would likely be a Manager, Director or VP within the Quality, Regulatory, Engineering, or Manufacturing roles of a pharmaceutical, medical device, or biologic company.

But, the great thing is that once the subscription is established, anyone in the company who has been given the subscription number by their administrator can make use of the service by simply submitting a request form to us. We are hoping that the service will be routinely accessed by engineers, quality supervisors, regulatory associates, manufacturing specialists in addition to the higher-level management staff. There is a great variety of document reviews and consulting support we can provide remotely and we have subject matter experts with an impressive range of specialized experience, so the audience we can service is broad.

Q:

You have a lot of industry "know how" when it comes to consumer needs. Talk a little about how that played a role in creating QReview.

A:

I have been in FDA regulated industry for almost 30 years.  I started my career as an investigator in the Dallas District Office, and I was on the international inspection team as well.   FDA was my first job out of college so I cut my teeth on regulation and steered toward medical devices as my preferred area for work.  I left FDA to take management and director level roles at several FDA regulated companies and eventually left industry to start consulting.  As a consultant, I found myself back doing what I did as an investigator, primarily auditing, but now also found the opportunity to train, coach, and build solutions to difficult problems.  I realized several years ago, that after on-site visits with a client, much of the follow-up work was being done remotely.  Like most of us, over time I got experience using SharePoint, Teams, and technology such as Web-Ex and later Zoom for collaborating remotely. 

Our industry is global so even when I was on site working with a client, I often had to meet remotely with team members resident in other countries.  The global nature of Life Science industries has resulted in most of us getting comfortable with the use of technology to help us communicate, meet, and share information and data in a collaborative fashion.   This experience let me to think that we could really structure a whole service area around providing remote support to clients on an “as-needed” basis with quick turn-around times.  The subscription model seemed like a solution for allowing multiple people in a company access a shared pool of consulting hours that they could use to engage quickly with one of our subject matter experts.
 

Q:

How does QReview differ from what a client would expect?

A:

It is important to note that QReview is an additional service offering and is intended to augment, not replace, the traditional project-based consulting that has QualityHub has provided to regulated industry for almost 20 years.  Project based services, for example, QMS audits, remediation of QMS processes, response to regulatory inspections, and regulatory filings, necessarily require clear scoping of work, highly specific deliverables, and a budget.  These types of services are best defined through a Statement of Work, often followed by more detailed project plans, protocols, and schedules.  This work is then billed against a Purchase Order (PO).  Once that project is completed, the next project would require a new SOW and PO.  

Q:

What really sets QReview apart from other consulting services?

A:

QReview, allows a client to purchase a package of consult hours (25, 50, or 100 hours) that can then be used for a variety of intermittent consulting needs and by multiple employees.  It provides quick remote access to an expert for a request that may only require an hour or two of time or in other cases may require several days of time. QReview provides great flexibility allowing for intermittent ad-hoc consulting needs to be quickly met. Instead of billing on the back end for each hour of service used, we keep track of the number of hours used and the balance on the subscription, providing periodic updates to the client’s Subscription Administrator.  There is no need for us to invoice weekly or monthly and no need for the client to then process that invoice, submit payment, etc. This reduces overhead for both the client as well as QualityHub where the services are intermittent as opposed to more complex projects executed against detailed plans or protocols.

Q:

Do you have any situations that would be resolved using QReview?

A:

Yes, actually! We have several case studies that we’re pulling together that already show the success we’ve had for our clients thus far.

 

Q:

What are your favorite features offered by the service?

A:

It provides ad hoc access to experts who can meet intermittent needs for document reviews or quick consults without the time and associated overhead in developing SOW and Purchase Order process each time this help is needed.  As a service provided remotely, there is no need for travel expenses.  We really think this is going to be unique and affordable way for our clients to get quick help with an technical questions, regulatory and quality issues, document reviews, etc.  This service really makes sense when a client just wants, for example, to ask an expert a question or get a fresh set of eyes on a CAPA file before it is closed, or get input on a new design FMEA template.  Once the subscription contract is approved, on-going requests for assistance can be met quickly. 

 

Another thing that is exciting is that this process gives our subject matter experts the opportunity to share their wealth of knowledge and experience.   As someone who has consulted for over 20 years, I feel that the most rewarding part of the job is teaching and coaching.   Helping someone really understand not just what to do but why is it necessary or important helps integrate quality and compliance into our products and processes.  QReview provides a real opportunity for employees in a variety of functional areas to have unprecedented access to QualityHub’s top notch team of experts.