Telepublishing Inc. : Computer Consulting Services : Unix/Linux/Windows/Networks/Internet/Security/streaming media : Administration/Development/Engineering/Integration/Support

The 21 CFR Part 11 regulation has mandated validation of computer systems used in FDA-regulated Good Practice (GxP) activities and regulatory filings. Our step-by-step validation support is an integral part of delivering compliant solutions for your needs.

Through years of FDA-regulated application experience Telepublish has created validation tools, training and consulting services packages using GAMP guidelines. Through these comprehensive and proven validation packages, Telepublish customers are provided with all the detailed support needed to establish proper validation processes and ensure that compliance with the 21 CFR Part 11 regulation is achieved in a timely and cost-effective manner.

In addition to written and executions of Installation Qualification (IQ) and Operational Qualification (OQ) validation test protocol scripts, Telepublish provides comprehensive Performance Qualification (PQ) training and services. Telepublish offers cost-effective solutions to facilitate team members in completing their validation requirements.

We can help you:

	Conduct computer systems compliance risk assessments.
	Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
	Execute test plans and document results in a Final Summary Report.
	Establish computer system life cycle methodologies, change control policies and procedures to maintain your validated state.