cGCP Software Systems

MasterControl cGCP Software Systems are Designed to Help Companies Maintain Compliance and Streamline Clinical Processes

According to the U.S. Food and Drug Administration (FDA), the observance of current good clinical practices (cGCPs) - including adequate human subject protection (HSP) - is globally recognized as a critical requirement when conducting any research that involves human subjects. In fact, FDA regulations for conducting clinical trials have emphasized both cGCP and HSP for more than three decades. Consequently, many countries have officially adopted cGCP standards as their principal guidelines. cGCP software systems can provide indispensable tools to help organizations better manage clinical processes according to regulatory guidelines.

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In efforts to keep pace with cGCPs, companies face innumerable challenges in controlling and managing documents that are critical to regulatory compliance during clinical phases. cGCP software systems like those offered by MasterControl can be implemented to meet compliance requirements and can specifically help customers:

  • Achieve compliance with cGCPs and maintain compliance year after year
  • Manage quality activity across the GCPs
  • Integrate compliance into corporate culture so that each department across the enterprise is able to meet compliance standards
  • cGCP systems connect people with appropriate clinical data and processes to ensure that every involved party is able to see the "big picture"
  • Meet the challenges of GCP multi-site study requirements
  • Manage clinical trial site information including institutional review boards (IRBs)
  • Handle process-based inspections

Features and Benefits of MasterControl's cGCP Software Systems

  • A Complete cGCP Software Solution: A clinical trial involves a variety of documents, tasks, and processes that are most often dependent upon each other and share common information. Integrated modules increase reuse and efficiency throughout the clinical trial process.
  • Industry Recognized Best Practice: The Drug Information Association Trial Master File (DIA TMF) Reference Model has been adopted as an industry best practice standard for ensuring completeness of documentation for a clinical trial from various resources both internal and external to an organization.
  • Simple Implementation: Since many employees are already familiar with the DIA TMF Reference Model, using MasterControl's Reference Model TMF Jumpstart configuration decreases implementation time, ensures that companies get a standardized configuration, and reduces the learning curve.
  • Risk Management: MasterControl is a comprehensive cGCP system in that it features risk management functionality designed to enhance transparency and manage risk throughout the life of a clinical trial, thereby increasing compliance throughout the entire clinical trial process.
  • Mobile Access: External light users and mobile users can quickly access information critical to their roles (whether they are a monitor, auditor, or investigator) and accelerate the flow of information and the execution of tasks. In so doing the organization is also able to reduce cycle time (i.e., review, approval, and training).

MasterControl cGCP Solutions

MasterControl cGCP software systems provide proven solutions for:

TMF Document Management - Document Management

  • Document Types, Metadata, and Taxonomy based on the Drug Information Association's (DIA) Trial Master File (TMF) Reference Model
  • Workflows: Routes, Collaboration, and Electronic Signatures

Clinical Processes Management - Process Management

  • GCP: Trial Initiation, Closeout, Clinical CAPA

TMF Project Management - Project Management

  • Project Plan Template based on the DIA TMF Reference Model
  • Integrated Project Tasks: Documents, Processes, etc.

Clinical Site Management - Site Qualification and Relationship Management

  • Site Information (Facilities, Equipment, Audit History) and Documentation

GCP Audit - Audits

  • Clinical Site and Partner (i.e., CRO, CMO) Audits

GCP Training - Employee, Partner, and Investigator Training

  • Configurable Test/Quiz Setup

Clinical Risk Management

  • Project Risk - Study Timeline, Tasks Overdue, Completion %
  • Clinical Procedure - GCP Documentation, Patient Enrollment, Safety, Data Integrity, Product Accountability / Storage, CAPA/Deviations (Volume, Frequency, Trends)
  • Site Management - Investigator Selection / Site Qualification, Audit History, Deviations
  • Audit - CRO & Site Audits: Violation, Finding, Deviations, Follow-up / Corrective Action
  • Training - Completed, Outstanding, Overdue

Mobile Access

  • Access Documents, Processes, Tasks, and Training Courses from tablets or smartphones.

MasterControl's cGLP Software Offers Real Solutions to Real Clinical Challenges

Some of the many pains of managing clinical processes that can be alleviated through the implementation of a cGCP software system include:

  • Managing all the documents, tasks, and processes that must be tracked during a clinical trial for compliance purposes
  • Managing the overwhelming volume of documents that make up a clinical TMF
  • Importing and exporting high value batches from a variety of sources (internal, CRO, clinical site, etc.)
  • Tracking site documentation and trial eligibility information from hundreds of sites for various clinical studies
  • Improving the quality of clinical data
  • Reducing negative findings and open cases from audit findings
  • Maintaining cGCP compliance training records

Here's how the MasterControl cGCP software system helps solve or simplify these types of clinical headaches:

  • MasterControl's unique Reference Model-TMF JumpStart configuration is based on the DIA Reference Model which increases efficiency and provides a central repository for all required TMF documentation
  • The MasterControl cGCP software system provides a variety of methods for batch importing and exporting of content to and from the system
  • The TMF project management capability allows users to plan their TMF documents and tasks as a Project with automated task reminders and updates as tasks are executed, escalated, and promoted though various lifecycles
  • Each clinical site's information and documents (including facilities, equipment, past trial participation, and audit history as well as site - and study - specific documents) can be linked, searched, and reported on
  • Integrated processes, audits, and site information allow quality tasks to be executed and closed out effectively and conclusively for enhanced compliance
  • Training can be customized by user role and methods used (ad hoc, virtual class, etc.) and can take advantage of available proficiency tools such as questionnaires, tests, and quizzes

For More Information on cGCP Software Systems

For more information about cGCP software systems for ensuring GCP compliance, please feel free to contact a MasterControl representative.