GCP Audit Management

Improve GCP Audit Proccesses with GCP Audit Software

Showing the validity of data from studies in support of pending marketing applications, adherence to FDA GCP regulations, and knowing whether the rights and safety of subjects have been protected are very important to complying with Good Clinical Practice GCP regulations.

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Actelion Pharmaceuticals (3:04)

How MasterControl Makes Your Job Easier (3:50)

Creating a Paperless Process Using MasterControl (3:38)

Download Free Documents
	White Paper: Ensuring the Adequacy of the Informed Consent Process in GCP Regulated Environments
	White Paper: FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments
	White Paper: Quality Audit - A Tool for Continuous Improvement and Compliance
	Webinar: Automating Quality Audits for Regulatory Compliance
	Interactive and Live Demonstration: MasterControl Quality Suite Demonstration

GCP Quality Challenges

A company's ultimate goal is to ensure the accuracy and quality of testing. To achieve this goal, companies must address many challenges, including:

Inefficient Quality System: Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during inspections.
Disconnected Processes: Quality processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to a documentation control processes is likely to cause delays in change implementation.
High Cost of Validation: High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a company successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.