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xLM’s ContinuousDI
Goal is to provide a set of managed services to go from where you are to Continuous Data Integrity (cDI) Compliance.
cDI Program based on ALCOA+. All our programs include Enterprise wide Data Integrity (DI) Assessment Services that encompasses Clinical, Manufacturing and/or Laboratory areas within a life science company.
Includes the following DI Categories: GxP Data Integrity, Data Governance, Data Lifecycle, Original Records / True Copies, All Computer System Transactions, Audit Trails, Data Review, User Access/System Admin Roles, Data Retention and Archival, Backup & Disaster Recovery, File Structures, System Validation, System Interfaces, and Data Risk Assessments
cDI Benefits
Our managed services adhere to our QMS which is based on ISO9001-2015, 21 CFR Part 11/ Annex 11.
Use TLS to protect information while in transit across the Internet. We have implemented TLS1.2 and Perfect Forward Secrecy (PFS) to further support data protection.
Technology Partners
cDI Platform Architecture
cDI Platform Key Features
Scrum Boards
Scrum boards help agile teams break large, complex projects into manageable pieces of work so focused teams, working in sprints, ship faster.Roadmaps
Keep your teams and organization in sync with roadmaps.Intuitive Analytics
Make data-driven decisions in record speed with Analytics. Use pre-built or customized dashboards to analyze your data across teams and projects.
The Data Lake offers fully modeled data across apps for faster analysis, directly inside the Platform or in your BI tool of choice.
Drag & Drop Automation
Focus on the important things. Let automation do the rest. Automation is simple, but powerful.
E-Sign any record
Execute electronic signatures on any issue. Each signature contains signee name, title, date/time, signature meaning and is locked cryptographically to the Issue.
PDF Signature Archives
Will capture a PDF point-in-time snapshot of
the complete “Signed” issue.
PDF includes standard fields, description, attachments, comments and all custom fields, plus eSign signatures , invites and verification.
Daily and On-demand Backups
Save time from manual exports and scripts with automated daily backups.
Trigger on-demand backups for all or specific projects or objects including attachments. Monitor and report backup activity for compliance.