123Compliance Medical Device Tracking Datasheet Page 1

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1 Datasheet Page 1 Deployed in the secure and trusted Salesforce.com (SFDC) cloud, the 123Compliance Medical Device Tracking solution is the 1st fully compliant and validated real cloud- based solution dedicated to meeting the FDA 21 CFR Part 821 regulatory requirements.! Maintain Regulatory Compliance! Reduce Regulatory Risk! Enhance Reporting Capabilities! Improve Validation Checks! Scale to the Global Team! Achieve Administrative Sustainability! Reduced Manual Efforts in Validation HCP Registry audit trail Account Audit Device Tracking role based security QMS e- Sig workflow Patient Registry Reporting & Analysis The 123Compliance Medical Device Tracking solution is 21 CFR Part 11 compliant, offering the flexibility, scalability, technical support, and audit assistance required by client s who are attentive of FDA compliance. Cloud Solution Overview 3 rd Party SalesForce UI Browser HCO/HCP Browser/Mobile Device Browser/Mobile Device Portal SalesForce Business Logic 123 Compliance Model & Logic Salesforce.com Database Data Interface Manufacturer Call Center Patient Manufacturer CRM/ERP

2 Datasheet Page 2 The 123Compliance solution is hosted in the cloud on the trusted and secure Saleforce.com platform. Medical Device manufacturers have direct access to 123Compliance from anywhere HCOs, HCPs and Patients may register via the Portal & Mobile interface The solution leverage CRM & ERP master data interfaces Provides enhanced data quality with 3rd party verification of addresses

3 Event Management Datasheet Page 3 The Device Tracking Event module guides the compliance agent through the entire tracking process from data entry to follow- up, verification, final quality review, and closure. Below is a screenshot of the device tracking event screen and configurable workflow.

4 Datasheet Page 4 Patient, HCO, and HCP Registry Patients, healthcare providers, and healthcare organizations are managed under the accounts module. HCO and HCP accounts may be imported on a nightly basis from your master data management systems if desired.

5 Datasheet Page 5 Regulatory Reports 123Compliance delivers two predefined reports to meet the recall requirements of 21 CFR Part 821. Patient Report: A report listing all pertinent information about the install base including the patient, the implanting physician, explanting physician, and the device. Shipped Device Report: A report listing of pertinent information for all devices that have shipped and have not been implanted. Dashboard The 123 Compliance is delivered with the below predefined dashboard, however, the dashboard may be configured by the customer to meet specific client needs.

6 Datasheet Page 6 Compliance Audit The compliance audit module provides an interface for planning and executing audits of devices/accounts. Compliance managers may generate a random list of accounts and devices to audit or generated targeted list of accounts/devices to audit based on very specific non- conformance criteria. Configurable Workflow 123Compliance provides a business facing user interface through which workflow processes can be easily configured to meet the standard operating procedures of any organization. Simply define the process steps, actions to be taken, and assign them to permissions groups, all without a single line of code. The configurable workflow process gives you the choice to automatically set records to a locked/non- editable state once close or cancel.

7 Workflow in Action Datasheet Page 7 Once assigned to a SFDC object, the visual workflow assistant will appear anytime a record on the object is created or edited. The visual workflow assistant will guide the user through the workflow process offering only the next logical steps in the process as seen below. Electronic Signature Configuration 123Compliance offers the ability to make e- signatures required when certain actions are taken, prompting the user to authenticate, and confirm their action prior to taken the action. When setting up the workflow actions simply indicate whether an e- signature is required and whether a comment is required along with the signature. Electronic Signature in Action e- Signature in action: As part of the visual workflow assistance process, the user will be prompted to provide an e- signature at the time of the designated workflow action as seen to the right.

8 Configurable Audit Trail Datasheet Page 8 Within the Audit Setup, clients may choose which fields will be audited within an object. Once configured, the audit trail will capture old and new values in audited fields when records are created and edited by users as see in the Audit History report below. Audit History Report Field Name Action Old Value New Value Audit Trail Entry: Last Modified By Last Modified Date Time Placement Updated - Left Jack Johnson 2/5/ :09 Disposition Updated Shipped Installed Jack Johnson 2/5/ :09 Grand Totals (2 records) Workflow History Report Status Action Change Summary Follow- up 1 Send to Follow- up 1 Send to Follow- up 1 was performed by Jack Johnson on :37:09. Status updated from Open to Follow- up 1. Com ment Workflow E- Sign Last Modified History: Last Applied? Date Time Modified By No Jack Johnson 1/31/ :22 Open Created with Status:Open No Jack Johnson 1/31/ :21 Grand Totals (2 records)