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Colgin Consulting, Inc. – Your GLP & GCP Studies Depend on Systems Operating as Intended. We Help Make Sure They Do.

Your GLP & GCP Studies Depend on Systems Operating as Intended. We Help Make Sure They Do.

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Colgin Consulting, Inc. – Your GLP & GCP Studies Depend on Systems Operating as Intended. We Help Make Sure They Do. | colginconsulting.com Reviews

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Your GLP & GCP Studies Depend on Systems Operating as Intended. We Help Make Sure They Do.

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1

Integrated Computer System Compliance Audits – Colgin Consulting, Inc.

http://www.colginconsulting.com/services/integrated-computer-system-compliance-audits

Colgin Consulting, Inc. Integrated Computer System Compliance Audits. Integrated Computer System Compliance Audits. Protect your study by assuring systems operate as intended. We don’t just look at validation packages. Business processes supported by the system. How the system is operating in your business environment. What do you get? The information you need to answer two questions. Did following the procedures result in a system that operates as intended and meets applicable regulatory requirements?

2

3 Tips for EDC Audit Trails – Colgin Consulting, Inc.

http://www.colginconsulting.com/3-tips-for-edc-audit-trails

Colgin Consulting, Inc. Integrated Computer System Compliance Audits. You are here: Blog. 3 Tips for EDC Audit Trails. November 20, 2014. 3 Tips for EDC Audit Trails. What follows is more or less a transcript of my presentation at the joint annual meeting of the San Diego Regulatory Affairs Network and the Orange County Regulatory Affairs Discussion Group on 19 Nov 2014. The 3 tips? I recently attended th. EDC systems are a bit strange. For the adequacy, accuracy, and availability of case report forms?

3

Blog – Colgin Consulting, Inc.

http://www.colginconsulting.com/blog

Colgin Consulting, Inc. Integrated Computer System Compliance Audits. January 30, 2016. But the Instrument Doesn’t Let Us…. 8230;use access controls…implement audit trails… During a clinical lab audit, you come across an instrument that doesn’t have access controls or an audit trail. You raise the problem as a finding during the audit, and the auditee objects: “Where is THAT written? January 4, 2016. When is a CRO not a CRO? And why does that make enforcement hard? Tagged With: Clinical Lab. New FDA Q&#0...

4

About – Colgin Consulting, Inc.

http://www.colginconsulting.com/about

Colgin Consulting, Inc. Integrated Computer System Compliance Audits. For Directors of Quality Assurance who need to ensure the integrity of their preclinical and clinical data, Colgin Consulting specializes in Integrated Computer System Compliance Audits. Unlike other CSV Consultants and Auditors, our comprehensive approach. Clearly identifies your risks and issues. Links them to GLP and GCP regulatory requirements. Your company’s research is changing lives. We can help you craft a strong response.

5

Remediation Assistance – Colgin Consulting, Inc.

http://www.colginconsulting.com/services/remediation-assistance

Colgin Consulting, Inc. Integrated Computer System Compliance Audits. Resolve problems and reduce the likelihood of additional regulatory action. When a company receives findings during a regulatory inspection or an audit, it can be hard to know where to start with a response. With years of experience crafting responses to regulators worldwide and negotiating responses with auditors and auditees, we can help you get off on the right foot. Want to learn more? Integrated Computer System Compliance Audits.

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Colgin Consulting, Inc. – Your GLP & GCP Studies Depend on Systems Operating as Intended. We Help Make Sure They Do.

Colgin Consulting, Inc. Are your IVRS configurations and customizations programmed correctly? Can your provider explain an image’s audit trail as it moves through their process? Are your lab’s electronic records. Are your central ECG systems reporting QT intervals correctly? How is your provider helping you maintain the integrity of your ePRO data? How are your clinical teams managing access to investigator site data? Confidence in your Preclinical and Clinical Data. Vice President, Quality and Compliance.

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