Quality Control Audit
During a quality control audit, an auditor independently inspects quality control activities, observing the performed controls in each procedure and confirming that the staff is accomplishing their work in such a way that it meets the product's stated specifications.
.Downloads
Quality Control Audit and MasterControl™
A quality control audit involves verifying procedures for a number of items, including:
- The operational functioning of a quality control department
- Verification of the existence of proper facilities and equipment for quality control activities
- Inspection and confirmation of SOPs
- Confirmation of laboratory analysis
- Verification of technical knowledge
- Records inspection
Quality control audits can be GCP audits, GMP audits or GLP audits. An audit checklist is usually compiled before the audit is conducted to ensure that no stone is left unscrutinized during the audit process.
An automated compliance solution, or audit management software solution, can facilitate a quality control audit. MasterControl QAAD™ is the perfect solution to meet all your quality and compliance needs.
The MasterControl QAAD audit solution consolidates all relevant quality programs into a single comprehensive system. This allows validation and support efforts to be shared organization-wide. Fully validated according to U.S. CFR Part 11, MasterControl QAAD provides maximum flexibility without the need for vendor intervention, external consultants, or additional programming. It's a paperless solution can help you achieve and maintain regulatory compliance by automating, streamlining, and effectively managing quality processes.
During a quality control audit, an auditor needs all the relevant paperwork in one place for review. If information is scattered across the company in several departments, or even multiple sites, focusing on a challenge will be time-consuming and frustrating. MasterControl QAAD's central location provides the ability to focus on problem areas across a company.
MasterControl QAAD can also be configured to completely automate the reporting process. The system also provides electronic report signatures and actionable responses to reports.
About MasterControl™
MasterControl Inc. is a global provider of GxP process, quality audit, and document management software solutions for life science companies. MasterControl™ products are easy to use, easy to deploy, easy to validate, and easy to maintain. They incorporate industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies, including 50 percent of the top 20 pharmaceutical enterprises, currently use MasterControl solutions for easier compliance, faster validation, and better process management. For more information about MasterControl, visit www.mastercontrol.com, or call 800-825-9117 (U.S.) or +44 1256 325 949 (Europe).
To learn more about MasterControl and audit control, visit MasterControl’s Resource Center. The Resource Center offers industry white papers, product data sheets, Q&A’s, case studies and webinars which provide extensive information for companies seeking new tools for change management.
|
