Oracle Risk Management and Compliance

Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-Shop

With ClusterSeven Shadow IT Manager, gain control over the hidden spreadsheets and other data assets that put your enterprise at risk. Discover and manage the hidden, sensitive spreadsheets, applications, and data assets that lie outside of IT’s control – and create risk. Now you can easily and efficiently capture and maintain an inventory of the files your organization relies upon and monitor who’s making changes, helping you meet audit and compliance requirements and prevent problems before they impact your enterprise. Classify the risks associated with your newly discovered EUC files and organize them in a centralized database. Once you’ve established the spreadsheets your organization is using, you can carry out a deeper risk analysis on critical files using rules that matter to your business, such as the complexity of a formula or macro, use of sensitive terms in the file like “confidential,” inclusion of unprotected client or personal data, or the presence of hidden worksheets.