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GXP International | Computer Validation & IT

Purchase our PDF training chapters. Book & Blog. We audit internal and external computer systems, data services, data centers, and application suppliers to FDA Part 11, EU GMP Annex 11, and GCP/GLP/GMP = GXP global regulations. We audit validation packages from suppliers (OQ), data centers (IQ), and end users (PQ). With a chat note and we can discuss your specific needs and interests. I look forward to hearing from you! Concord, MA 01742. Sign up for our email newsletters. What’s New with GXP.

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GXP International | Computer Validation & IT | gxpinternational.com Reviews

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Purchase our PDF training chapters. Book & Blog. We audit internal and external computer systems, data services, data centers, and application suppliers to FDA Part 11, EU GMP Annex 11, and GCP/GLP/GMP = GXP global regulations. We audit validation packages from suppliers (OQ), data centers (IQ), and end users (PQ). With a chat note and we can discuss your specific needs and interests. I look forward to hearing from you! Concord, MA 01742. Sign up for our email newsletters. What’s New with GXP.

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1 now available

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4 industry collaborators

5 quality statement

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now available,today,dr teri stokes,industry collaborators,quality statement,services,industry events,book store,blog,reference library,podcasts,audits,consulting,training,welcome to,international,131 sudbury road,email drstokes@gxpinternational com

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GXP International | Computer Validation & IT | gxpinternational.com Reviews

https://gxpinternational.com

Purchase our PDF training chapters. Book & Blog. We audit internal and external computer systems, data services, data centers, and application suppliers to FDA Part 11, EU GMP Annex 11, and GCP/GLP/GMP = GXP global regulations. We audit validation packages from suppliers (OQ), data centers (IQ), and end users (PQ). With a chat note and we can discuss your specific needs and interests. I look forward to hearing from you! Concord, MA 01742. Sign up for our email newsletters. What’s New with GXP.

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gxpinternational.com

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Quality Statement - GXP International

https://gxpinternational.com/quality-statement

Purchase our PDF training chapters. Book & Blog. It is well known that quality must be built into a product from the start and cannot be tested in after production is completed. In like manner, computer validation must become an integrated part of the normal business function using computers. GXP. International cannot warrant that clients will pass full FDA inspection based solely on the work performed by GXP. International as requested by FDA inspectors. The scope of GXP. The rework/resolution effort wi...

2

Reference Library - GXP International

https://gxpinternational.com/reference-library

Purchase our PDF training chapters. Book & Blog. Free Downloads from this Library:. All of Dr. Stokes’ published journal articles are available here for you to read and download as you wish. The four part series published in 2000 is a standard reference that has been a popular download. Part 1 features the End User PQ Package. Part 2 discusses the IT IQ package. Part 3 explains the Software Supplier’s OQ package and Part 4 presents the roles for QA and QC in computer validation. By Teri Stokes, Ph.D.

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Stokes Chairs Symposium at DIA in Washington, DC - GXP International

https://gxpinternational.com/stokes-chairs-symposium-at-dia-in-washington-dc

Purchase our PDF training chapters. Book & Blog. Stokes Chairs Symposium at DIA in Washington, DC. June 29, 2015. Teri chaired a symposium at the DIA Annual Meeting in Washington, DC titled Frontier Issues in Electronic Information Integrity Today. Speakers included the following:. Andrew Harbrow, RPh (UK) Medical Information Database: To Validate or Not to Validate That Is the Question. Breffni Martin (Ireland) The Risk of Risk Assessment. Sign up for our email newsletters. What’s New with GXP.

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Industry Events - GXP International

https://gxpinternational.com/courses-conferences

Purchase our PDF training chapters. Book & Blog. Electronic Archiving for Regulatory Content Industry Expert Panel. Listen to this webinar with a panel of experts to learn how to build towards and manage e-archiving in compliance with regulatory mandates and industry best practices. Archiving Industry Expert Dr. Teri Stokes, Ph.D., Director GXP International. Practicing Archivist Dave Ives, Assoc Director, Regulatory Operations, Vertex Pharma. Listen to the webinar here. In Basel, Switzerland. UBM India ...

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Services - GXP International

https://gxpinternational.com/services

Purchase our PDF training chapters. Book & Blog. Services and Products: Audits, Validation Projects and Training. We are industry leaders in developing Corporate Policy on computer validation and then translating policy into action at the operations and project level. Training at all levels is part of the interactive process we use on system projects. Team Working Sessions produce real documentation and are customized to client needs for GCP, GLP, GMP, or Part 11 compliance. System Quality Assurance Plans.

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Pharmacovigilance related IT - Lindeq

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Audits and other support. Good Distribution Practice (GDP). Lindeq provides also pharmacovigilance related IT support. From PQ validation of computerized systems and safety database software to data migrating and mapping and EMA gateway testing. Together with our partner BaseCon. Lindeq offers also a complete and resource saving safety database software including drug safety services. Of computerised systems (PQ). We plan your validation process and assist your validation team. We also streamline you...

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Science / IT Consulting. Uses surveys, interviews, and observation to conduct a comprehensive service audit. Monitors Key Performance Indicators at regular intervals, adjusting strategies as needed. Once we have executive buy-in, we oversee the implementation process from start to finish. We identify technology, training, and processes to take your business process to the next level. OUR Staff HAVE BEEN EVERYWHERE Virology Labs TO WALL STREET. On-site and Virtual audits.

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GXP International | Computer Validation & IT

Purchase our PDF training chapters. Book & Blog. We audit internal and external computer systems, data services, data centers, and application suppliers to FDA Part 11, EU GMP Annex 11, and GCP/GLP/GMP = GXP global regulations. We audit validation packages from suppliers (OQ), data centers (IQ), and end users (PQ). With a chat note and we can discuss your specific needs and interests. I look forward to hearing from you! Concord, MA 01742. Sign up for our email newsletters. What’s New with GXP.

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