IntegPro Data Integrity Auditing System

IntegPro is a purpose-built solution designed to help you monitor, track and manage your company’s data integrity compliance status.  Based on FDA’s guidance on data integrity, the software allows heads of quality, departmental heads and system owners to know their data integrity compliance status at a glance, understand the compliance gaps, and help take remedial action.

IntegPro is fully compliant with 21 CFR Part 11 requirements and hence can be used for paperless tracking and management of data integrity status.

The software is designed to be used by departments or as part of a corporate initiative for data integrity compliance.

  • Quick and easy tool for efficient management and tracking of data integrity processes in your company
  • Paperless management of data integrity status tracking for improved compliance
  • Ready to use out of the box with pre-built configurations
  • Highly flexible and configurable to the needs of your organization
  • Easy to configure, use and maintain
  • Zero Client Web Based solution – no installation required on desktop

Audit Trail Data Integrity Audit Management

  • Create system inventory
  • Assign each system to owner
  • Have owner update status and complete data integrity audit questionnaire
  • Track status

Reporting and Tracking

  • Email notifications on system updates
  • Role-based reporting

21 CFR Part 11 Compliance

  • Audit trail records the date, time, user ID, type of action and other details
  • Role-based assignment of security security rights, privileges and roles
  • Configure actions that require electronic signatures
  • Password Aging forces a new password after a configurable period
  • Account lockouts after a configurable number of retries
  • Automatic Session time-outs

Installation

  • CSI offers installation services to install the software. Installation services can ensure proper system installation and operation in your computing environment during initial system start-up and implementation.

Product Configuration

  • CSI offers Product Configuration services to configure IntegPro to your specific requirements and applications.
  • CSI’s product experts can help you optimize your implementation of IntegPro and derive a maximum return on investment based on a keen understanding of business processes, industry best practices and product knowledge.

Training

  • CSI offers training services geared towards IntegPro users, administrators, and “train-the-trainer” services.
  • Training can be scheduled onsite or offsite.

Product Maintenance and Support

  • CSI product support and technical services are just a phone call away. CSI standard support services include technical support via phone, email or online support tools, as well as product upgrades and new versions. Premium 24 x 7 support services are also available.

Electronic Records and Audit Trail

Audit Trail:

  • Stores all user actions in an audit trail with timestamp, user ID, action performed and other fields as applicable.

Administrator Audit Trail:

  • Stores all administrator actions such as e-signature configurations, reason field assignments, user management, and user privileges.

Configurable Reason Fields:

  • Set to optional or required based on object/action combination.

Electronic Signatures

E-signature Templates:

  • Create e-signature templates defining the operations that require e-signatures

Configurable E-Signature Assignment:

  • Different templates can be applied to different actions for unlimited flexibility and control.

E-Signature Roles:

  • Define meanings (roles) for e-signatures and restrict user authority for e-signatures to specific roles.

Security

Protection of Data:

  • Data is stored securely in the system database.

Role based Assignment:

  • Assign roles like System Owner, Department Manager, and System Administrator to each user.

Role Based Access:

  • Different security templates can be applied to different roles for unprecedented flexibility and control.

Password Management

Password Aging:

  • Force a new password after a configurable amount of time.

Password Lockouts:

  • Lockout the account after a configurable number of retries.

Session Timeouts:

  • Logout from the application after a configurable session time-out period.