Macros for validating data in excel

Industry representatives met many times with the FDA's task force under Paul J.

Motise to determine how to accommodate paperless record systems under the current Good Manufacturing Practice (c GMP) regulations.

In many situations using computers cannot be avoided, for example in analytical laboratories for automated data acquisition and evaluation.

In this case the laboratories “must” comply with Part 11. There may come a time when the FDA will no longer accept paper records and; Electronic records have some significant advantages vs.

Two Audio Seminars are included in the Part 11 compliance package.

This was done in response to requests from the industry.

With this regulation, titled Rule 21 CFR Part 11, electronic records can be equivalent to paper records and handwritten signatures.

Five 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. Online Audio Seminars come with 10 Best Practice guides for easy implementation Risk Based Validation of Computer Systems and Part 11 Compliance With Strategies for FDA/EU Compliance and Tool Kits for effective implementation Recorded, available at any time Ensuring Data Integrity for FDA/EU Compliance Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records Recorded, available at any time Using Electronic and Digital Signatures in Regulated Environments Comply with FDA Part 11 and with international regulations and guidelines Introduction and Strategies and Tools for Implementation Recorded, available at any time FDA's New Enforcement of 21 CFR Part 11 Strategies and Tools to implement FDA's New E-records&Signatures Directions Recorded, available at any time Recent Warning Letters and 483's Related to Computer Validation and Part 11 With Case Studies to Avoid and Respond to 483's and Warning Letters Recorded, available at any time Computer System Validation: Step-by-Step With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation On demand Part 11 primer.

master plan, project plan, examples, checklists, audio seminar and 11 SOPs for easy implementation Click here for more info Frame work to develop your own Part11 project plan Guides you through your Part 11 project: step-by-step, as easy as 1-2-3.

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Learn through interactive video seminar about FDA's ' NEW' Part 11, what's coming and how to implement.

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  1. Auflage 2017, ISBN print: 978-3-8487-3363-7, ISBN online: 978-3-8452-7689-2, DOI: 10.5771/9783845276892-165 Reihe: German and European Studies of the Willy Brandt Center at the Wroclaw University, Bd.