Flexible and Scalable On-Demand Remote Document Reviews and Consultation to Regulated Life Science Companies

What is QReview?

QReview is an On-Demand remote document review and consulting service, that gives you the expertise you need, when you need it. Unlike traditional consulting services that are set-up on a project-by-project basis, QReview is a subscription service. Your annual subscriptions gives your whole company or team on-demand access to subject matter experts who can provide technical, quality, or regulatory reviews of documents and records or provide answers to your compliance questions.

 

Why Use QReview?

QReview is designed to provide FDA regulated companies supplemental resources and expertise for:

  • Meeting critical deadlines
  • Mitigating time and resource constraints
  • Reducing business and compliance risk by improving the quality and clarity of document content 
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Want to Learn More?

Types of Documents

Quality

  • CAPAs
  • Complaints
  • Nonconformances/Deviations
  • Root Cause Investigations
  • Quality Data Analysis
  • Quality Plans
  • Internal audit reports
  • Internal audit responses
  • Recall, HHA/HHE
  • Product Quality Issues
  • Quality System Issues
  • Management Rev Data Prep

Technical

  • Design Input & Output
  • Design Plans
  • Design reviews
  • Design Transfer Plans
  • Design V & V
  • Process Validations
  • Test Method Validations
  • Protocols & Reports 
  • Technical Files
  • Device History Records
  • Batch Records
  • Product Specifications
  • Document Control issues

Regulatory

  • Regulatory Strategic Plans
  • Premarket Submissions
  • Supplements
  • Adverse Events, MDRs
  • Product Labeling
  • Communications
  • Regulatory Meeting Requests
  • Registration and Listing
  • Regulatory Submission Issues

Let us answer your questions!

Why subscribe?

QReview can reduce business and compliance risk by improving the quality and clarity of your documentation.

Our partners in the medical device, pharmaceutical and biologics industries will from on-demand remote access to high-quality resources without the costs of consultant travel and processing new contracts and POs for each review or consulting event. Benefits include:

  • On-demand access to QualityHub’s expansive network of subject matter experts experienced in performing critical reviews.
  • Reduction in costs associated with maintaining consultants in travel status.
  • Improved inspection and audit readiness of important records and documents.
  • Mitigation of workflow bottlenecks and backlogs.
  • Opportunity for an unbiased quality review (i.e. independence from the current working team).
  • Improved documentation and outputs to meet regulatory guidelines, expectations, and best industry practices.
  • Independent assessment of critical documentation that drives decision making.
  • Improve clarity and content of documentation and records.
  • Increased confidence that the right objective evidence is provided to support actions taken.
  • Reduction in document rework or reject by approves.
  • Reduction to the client’s carbon footprint.
Who provides the remote service?

We can provide a variety of remote auditing & consulting resources depending on the type of review or consult submitted. QualityHub has an excellent reputation for technical and regulatory knowledge and ability to interpret regulatory requirements and apply these to a variety of product types.

We have experts in most of the life sciences areas, as well as former FDA staff, RA/QA professionals, healthcare professionals, biologists, chemists and engineers. Our experts have broad experience in product development, production, testing, engineering, quality, purchasing, training, operations and also pre and post-market requirements for medical devices, pharmaceuticals and biologicals. We will be “at your service” remotely on an “as-needed” basis.

You will receive the consultant’s resume (qualifications) for your records and if necessary you can request an alternate resource.  In most cases, we will keep the same reviewer working with you to ensure continuity as long as the document types or technical subject matter remains the same.

Our reviewers have been trained on our unique QReview process and are ready to help.

How do I use my subscription hours?
  1. We will work with you to quickly get an NDA and Subscription Service Agreement in place.
  2. Upon approval, QualityHub provides access to a client-specific SharePoint folder (or we can accommodate the use of your companies file management system or limit information to transfer by email).
  3. On an as-needed basis, your team members can submit a QReview Review/Consult Request Forto specify the types and number of documents you would like reviewed, or the topic you wish to discuss with one of our consulting staff. Our project management team will quickly process your request.
  4. For significant “business-critical” documents you can also request a peer review. If requested, an expert or an executive level consultant will provide a secondary review of the consultants’ deliverables to add commentary, and, if needed, verify alignment of content with the appropriate regulations. (This might be helpful for documents that are particularly business-critical.)
  5. We match your request to the appropriate SME(s) and upload their resume(s) for your files.
  6. Documents are uploaded to a secure location, and, as-needed, conference or video calls are set-up for consultation or desk-top sharing. The SME provides the requested review or assistance, returning redlines or comments.
  7. Follow up meetings can be set up, as needed. Turn-around times for document reviews are intended to be short but depend on document complexity.
  8. QualityHub monitors the utilization of hours against your subscription package, providing periodic balance or expiration updates.
What about security and confidentiality?

QualityHub understands the importance of client confidentiality and the protection of proprietary information.

QualityHub’s strict guidelines and processes ensure confidentiality is maintained during and after the document review and/or consultation process:

  • QReview provides a secure, encrypted means for transferring and storing documents and records on a secure cloud-based platform.
  • When processing your subscription, QualityHub will establish a client-specific confidentiality and non-disclosure agreement. This can be done using your NDA or ours.
  • All of our SMEs and consultants have signed confidentiality and nondisclosure agreements that extend from QualityHub to all of our clients, projects and associated information.
  • The subscription service agreement includes reference to the protection of confidential and proprietary documentation.
Do my subscription hours roll over?

We know flexibility is important. It can be challenging to predict how much consulting time you will need in a year.

We have two subscription packages that allow you to choose either 50 or 100 hours of review/consult service.

We suggest choosing the plan that fits your needs, and we are happy to help guide you through that process. Once the subscription has begun, it will be up to you to make requests for our services as time progresses during the plan.

Per our policy, you can choose to use or to not to use the remaining hours on your subscription. We will do our best to notify you of hours that are remaining throughout the subscription period.

Can I cancel my subscription?

Our goal is always to meet or exceed our customers’ expectations. We will do our best to resolve any concerns you might have regarding your subscription service.

You may cancel your subscription at any time. However, per our policy if you cancel your subscription, we do not provide refunds for unused hours.

If you are unable to use your hours within the subscription time period, you may choose to renew for additional calendar year and apply those unused hours to your subscription time period. Please see the Roll-Over section for more information. 

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We have options that allow flexibility and economy of scale to meet your unique needs.

Ready to set your company up for success? Let’s Talk