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This Month On IVT Network |
| Analyzing the FDA Process Validation Guidance |
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The FDA Process Validation Guidance is thoroughly analyzed and dissected in this presentation from the Validation Essentials webinar. Read More |
| The QA/IT Relationship—Go From Antagonism to Harmony |
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There are some clarifications, attitude shifts, and behavior modifications that can easily reconcile the groups and create a team-like mentality between QA and IT. Read More |
| The 5Ws of Network Infrastructure Qualification |
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Network infrastructure qualification is a rapidly evolving, multi-faceted practice. As desktops, servers, network services, networks, and data centers continue to evolve, there are consistently reoccurring questions that they continue to be raised during qualification. Read More |
| The Top 53 Computer and Software Validation Regulations |
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Confronted with increasingly complex technologies, cloud computing, data security issues, and digital media, companies are consistently struggling to remain compliant in the face of increased regulatory scrutiny. Read More |
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| IVT PRODUCTS WITH YOUR MEMBERSHIP |
| Revalidation Assessment |
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This revalidation assessment provides for the evaluation of validation change control, maintenance and calibration records, operating and maintenance procedures, equipment logbooks, and other evidence as necessary. Read More |
| Gap Analysis Checklist for an Equipment/System/Facility Change Control Program |
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This checklist ensures that all change control items; including change control in facilities, computerized systems, documentation, training, and outsourcing; are thoroughly accounted for during a gap analysis. Read More |
| Procedure for Design Review and Design Change Control Management for Facilities, Equipment and Systems |
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The purpose of this procedure is to provide guidelines for performing a design review for direct impact and indirect impact utilities, process equipment or systems. Read More |
| LATEST JOURNAL ARTICLES |
| EU Annex 11 and the Integrity of Erecs |
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The safety of a computer system is reflected by the confidentiality, integrity, and availability of the system. The integrity of the systems includes the integrity of the electronic records. Read More |
| FDA Cites Flow Cytometry RMM in Inspection Report |
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Since the very first rapid microbiology method was introduced, pharmaceutical companies have been concerned with the potential regulatory approval of these methods. Read More
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| USP Expert Panel Responses to Questions and Comments from IVT |
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At IVT’s Lab Compliance Week conference a session was held to discuss the USP stimuli article Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. Read More
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| FDA, USP, and the 503B Outsourcing Facilities |
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The past two years has seen dramatic change in the regulation of compounding pharmacies. Read More |
