Healthcare-Procipient

Procipient as a Solution for Healthcare 

How can you ensure a successful governance, risk and compliance (GRC) function with your production of medical parts, devices and pharmaceuticals?

Manages regulatory and compliance requirements for:

 

Procipient®

  1. Shows you have policies in place to address the specific assets and processes protected by HIPAA.
  2. Streamlines risk management efforts and gets simple reports to prove compliance.

Materials utilized to promote, advertise and educate people about products must have strict quality and version control

  • IFUs, Brochures, Websites, etc., must contain documented part numbers and version histories.

Any medical device’s traceability must be documented in a Device History Record (DHR).

  • DHR serves as a production record for medical devices that are manufactured and includes entries for acceptance records of individual units or batches of product, product counts, labels and any other applicable unique product identifiers.

The history and information on how you made the device in accordance with the Device Master Record (DMR) is stored in the DHR that contains the necessary specifications for building and testing a device, demonstrating the device was manufactured according to the information in the DMR to required FDA standards.

Procipient® facilitates meeting FDA standards by providing Intuitive, centralized document management with powerful reporting.

Executes Risk Analysis with:

 

  • Policies, procedures and enterprise documentation for regulatory, legal and compliance requirements.
  • Documentation for audits and examinations.
  • Manages document expirations and updates.
  • Visualizes and reports risk to management, the board, regulators and auditors with a single click.
  • Generates PDF, Excel, and Word documents that contain your Procipient information.
  • Exports data to integrate with other reports.
  • Alerts and reminders for action items.
  • Configurable framework allows you to adapt and grow your framework quickly and easily by identifying and mapping hazards and risks in an easy-to-manage view.
  • Issue and Remediation Tracking that prioritizes and facilitates corrective action.

Simplifies Risk Management by:

 

Procipient®:

  1. Shows you have policies in place to address the specific assets and processes protected by HIPAA.
  2. Streamlines risk management efforts and gets simple reports to prove compliance.
  • Expert consultation from industry professionals with over twenty years of risk management experience.
  • Procipient® increases efficiency in dealing with these regulatory requirements by:
  • Scoring your resource provisions against guidance, and easily see where resource allocation can be improved.
  • Assigning users to departments, functional areas, or specific processes or assets.
  • Mapping policies to appropriate parts of the organization.
  • Using dashboards, reports, workflows and user roles and permissions to simplify, streamline and prove management reviews.
  • Easily visualizing risk trends, and point-in-time risk and control assessments.