21 CFR Part 11 Compliant Electronic Data Capture System

Bookmark this page

DiggDeliciousFacebook

ClinicalPURSUIT contains all of the necessary data validation protocols to ensure that your patient registry software solution is compliant, secure and private.

Electronic Signature Validation. Global Vision Technologies’ advanced and secure workflow engine includes electronic signature validation. System access is limited to authorized individuals based on a unique user ID and encrypted password. Three levels of permissions are standard (adminstrator, sponsor, user/physician/coordinator) result in different authority access, different screen views and different functionality. Validation and signature authorization controls further limit access to unauthorized users. Signature validation occurs upon login and typically based on a business rule requirement where certain events or actions occurred and must be approved, reviewed or verified by a supervisor or manager.   

Record Retention.   All databases are archived nightly within our geographically diverse server farms.  Copies of archived data will always preserve their original content and meaning.

Complete Audit Trail.  Date and time-stamped audit trails ensure the trustworthiness, integrity and reliability of the records and database.  Any change made to a record contains a complete time stamp and includes the user login information.  Audit trails are integral and necessary when users are expected to monitor progress and create, modify or delete regulated records during normal operations.

Copies of Records.  Data dumps and patient information records are available and can be exported into a report at any time.   The types of file exports that can be performed include, but are not limited to:  PDF, XML, CSV, XLS.   The system includes the ability to search, sort, trend and filter records and data points.