QAG-Manager®

On-line Quality Agreements

In today's competitive business climate, with a growing number of geographically distributed or "virtual" companies, effective collaboration and timely notifications on Quality Agreements are essential. QAG-Manager® offers companies flexible, web-based Quality Agreements that expedite the Reviewing & Approving phases, allowing effective collaboration.

FDA has issued Guidance for Industry on Quality Agreements. We have designed QAG-Manager® based on FDA guidance to allow companies to quickly and inexpensively Build and Approve Quality Agreements (QAGs) that comply with health-care agency expectations by simultaneously enabling compliance and productivity.

Organizations can immediately built, Review & Approve QAGs with minimal cost and maximum speed.

Click here to Download the FDA's Guidance on Quality Agreements.


HOW IT WORKS

It's easy to get your organization in up and running quickly with QAG-Manager® On-line Quality Agreements.

FDA Guidance provides the foundation for this easy to use application, incorporating our experienced People and process enabling Technology to bring this quality Agreement solution online quickly.

Your system is securely maintained at our SSAE-16 compliant datacenter.

External user access is enabled using 2 factor authentication facilitated by secure mobile technology, allowing users to seamlessly operate from both inside your corporate network as well as securely over the Internet.

BENEFITS

  • Always up to Date: QAG-Manager┬« is constantly maintained. Upgrades to the most current versions of Hardware and Software included at no extra cost.
  • E-mail notifications assure timely awareness to quality & compliance related issues.
  • Two Factor Authentication using Mobile technology from Twilio®, providing unprecedented security and ease of use.
  • Highly scalable: Serves companies large and small; Subscriptions scale up or down to fit any size business, allowing rapid and cost effective solutions.
  • No Internal Footprint; Dedicated servers, network equipment, and physical space is all located in DCS data centers, providing you with logical and physical security at 99.999% uptime.
  • Part 11 compliant signature capability.

QAG-Manager® Functions

These easy to use functions follow the FDA's prescribed approach to developing and maintaining Quality Agreements between "Owners" and "Contract Facilities". No Matter which party you are this tool will Save you time and enable consistent and timely communication based on your agreements.



The Build Phase allows for on-line collaboration of the QAG. Visible History of each change, review and approval Tasks, and electronic signatures to manage life cycle of your Quality Agreements.


Building your QAGs just got a whole lot easier. After selecting the parties who are involved in the agreement, all your Required and Default QAG sections are loaded into the draft QAG for you.

All you have to do from there is remove unnecessary sections, modify the content of other sections to meet the needs of this unique agreement, Add Contacts and attachments and the QAG is ready for the next phase.

QAG-Manger Process


Collaboration Made Simple with the click of a button e-Mail is sent to the predefined contacts. External partners can review & update the QAG from anywhere. Secure Authentication allows only the contacts you defined to access the agreement.


Reviewing your QAGs had never been easier. Review tasks are e-Mailed to your pre-defined Contacts. They can open the QAG from anywhere using our integrated Twilio® Secure Mobile authentication. When they save their changes they are prompted to determine if they have completed their entire review. When all reviews are Complete you are ready for the next phase

Security & Compliance

All DCS SAAS servers are maintained in an SSAE-16 Type II compliant data center. In addition, security permission groups are configured to match internal roles in your organization as needed. QAG-Manger® is Validated to meet GAMP® V standards and is compliant with 21 CFR Part 11 compliant Electronic Signatures.


Approvals are Secure, Compliant & Easy:

Your Staff and your QAG Partner's staff can easily access the completely reviewed agreement and Apply a Part 11 compliant signature using our integrated Twilio® Secure Mobile authentication.


Approving your On-Line Agreements will save you and your QAG Partners a significant amount of time. Our unique configuration permits FDA compliant electronic signatures for all QAGs while providing a Mobile Enabled Two-Factor Authentication for added security.

Your Company will be offering the Best productivity tools possible to your clients.


Monitoring your Agreements to assure you are in compliance has never been so easy. Your Staff and your QAG Partner's Staff can easily locate the current QAG and review details of the agreed terms. If you are required to Notify your QAG Partner you can do this from the built-in Notification function. Once a Notification is created, the other party must acknowledge it. All notifications are automatically tracked for you.


Locate QAG terms faster than ever before. Each Request is captured in an electronic form. This core Quality management solution enables on-line Review and Approvals of each change request. This allows all Requests to be tracked to closure.

Notify your QAG Partner easily from within the QAG. A simple Click of the Notify Button will send an immediate e-Mail alert to all of the Contacts identified in the Agreement. One member from the receiving group must Acknowledge the alert. All Notifications, including who initiated and who acknowledged and the Alert status is tracked in the QAG Form.


Renewing QAGs is no longer a chore that everyone tries to avoid. In fact, we have made it so easy it will save you Days of time.


Starting with your existing QAG, we will alert you when it is nearing expiration. An e-Mail will be sent to all the Contacts when the existing QAG is within 60 days of expiration.

You don't have to reinvent the QAG, we copy all of the existing content into a new QAG and give it a new number. Now you can simply update any other items that need to be addressed and send it for review.

Same Simple Approval as the 1st time. The designated approvers are notified and access the QAG and approve using the same Two Factor Authentication as the previous time, regardless of whether there are new approvers or not, the process is the same.