QAG-Manager provides you with a flexible, web-based, tool that significantly shortens the review & approval of your Quality Agreements, enabling a much faster start time for your product or service.
Extending the value further, QAG-Manager is the only web-based QAG application that Notifies and Tracks the key points that you negotiated and makes Revisions and Renewals 3-4 times faster.
We understand how time consuming and frustrating it can be to get just one agreement Approved. You shouldn’t have to spend hours compiling comments and changes only to have that hard work stored away somewhere without adding any more value.
QAG-Manager was designed based on FDA’s Guidance for Industry allowing you to quickly Build, Review, Approve and Track compliance with Quality Agreements that comply with health-care agency expectations and simultaneously enable consistency and productivity.
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.
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.
Staffing and Outsourced Services: DCS is a full service partner, providing staffing options such as fully outsourced services and Temporary contractor support while you come up to speed.
Data Integrity Assessment and System Validation: DCS can provide your company with analysis and consulting services to augment your Quality and Compliance staff related to Data integrity Assessments using the latest PDA TR 80 guidelines and Agile Computer Systems Validation.
Migration: Many customers have existing quality and business platforms or older versions of software. Working with our partners, DCS can help you develop a strategy for migration, outline the risks, and facilitate migration activities that will allow your company to continue to evolve.
Integration with other Applications: DCS, along with our extensive network of partners, can integrate our applications into your existing systems.
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