VKS for Medical

HELPING YOU PREPARE FOR INDUSTRY COMPLIANCE

Meeting department or agency compliance is an unavoidable part and poses one of the major medical industry challenges. For example, medical companies distributing their products in the United States are familiar with the demands associated to FDA compliance. This compliance, albeit necessary, is a time-consuming and rigorous process for companies. Although using VKS cannot guarantee your compliance with such agencies, many of the requirements are easily met by configuring the multiple VKS security features appropriately.

A much sought after feature for compliance is the ability to rapidly produce electronic records. VKS’ sophisticated reporting system enables you to locate, and print or export complete reports quickly. These reports are easy to interpret and can be configured to contain all the information needed to provide a thorough history of each unit produced. A perfect companion to the electronic report is the Password Signature feature. This secure electronic signature enables a user’s signature to be recorded and included in the report.

These are just a few options that can help you complete agency requirements. Take a moment to browse the numerous security features and see how VKS can help you reduce the stress and effort required when it comes to industry compliance.

PUTTING YOURSELF UNDER THE MICROSCOPE

The crucial and sensitive nature of medical devices makes it imperative for companies in this domain to have the documentation required to prove they are accountable for each and every device that carries their name.

VKS makes it easy for you to track such information by using forms to gather data in real-time during the assembly of each unit. Forms can contain elements such as an electronic signature field, which requires that an active supervisor attest to the quality of the work being completed. This information is compiled into reports that are readily available to authorized users. Once assembled, you can retrieve your device’s history record by re-tracing the item’s serial number in VKS. This will give you access to all data relating to the item, including assembly data and inspection data.

In addition to collecting production data, VKS’ Audit Log feature allows you to access a record of actions performed on your system. The audit log records crucial information on system actions, such as the time, the location and the user, and makes them available to the VKS system Administrator, giving you increased insight into how VKS is being used.

YOUR PRODUCT IS YOUR PULSE

In 2015, the World Intellectual Property Indicators reported that 110,100 medical instruments patents had been filed worldwide. With such fierce competition, your intellectual property is valuable and needs to be protected. Keeping this in mind, VKS has put into place features aimed at helping you control and manage the access to your sensitive designs and information.

Knowing the value of your intellectual property, VKS’ system is equipped with standard access restriction tools such as Login Control, User Roles and Groups. Recently, VKS has introduced the powerful Access Control feature that allows system administrators to go beyond the basic control options and have absolute control over which users can view and access files.

For users that are privileged with access to sensitive information, numerous interface options can be configured to add an extra layer of protection around your data. An organization-wide confidentiality notice can be added to your user interface and will be displayed at the bottom of each VKS screen, as well as on each page of material printed from VKS.

Other safety measures, such as the multi-screen logout and session control options, are also available to help you protect your information against inattentiveness.