Electronic Raw Data within Regulated Environments - Definition, Recording and Archiving - Webinar By GlobalCompliancePanel - Health

Overview: All regulations possess demanding conditions with regard to vapor uncooked facts and other e-records.

The intent is to assure accuracy, integrity, authenticity, stability and accessibility involving data in the complete your life from generation for you to deletion. While the intent is the exact for all restrictions only FDA's 21 years of age CFR Part 11 as well as EU comparative Annex 11 have effectively defined needs but continue to get away from a good deal of place to get interpretations.

Reference materials with regard to easy implementation:

* SOP: Recording of GLP and GMP Raw Data. * SOP: Retention in addition to Archiving with Electronic Records * Checklist: FDA Record Retention in addition to Retrieval

Areas Covered while in the Session:

* FDA Requirements intended for diet info and meta info * FDA Inspection and enforcement practitioners * Recommendations through community endeavor forces: GAMP/ISPE manuals * Definition regarding uncooked data: first information vs. standard electronic formats, paper print-outs * Ensure and also display condition involving raw records * The importance associated with possibility examination with the software of uncooked data * Electronic document preservation throughout archiving time * Software to control and archive natural data and other electronic digital data * Data migration in order to fresh programs * Developing an operation for dependable uncooked info direction * Examples from laboratories, locations and manufacturing

Who Will Benefit:

* IT managers plus program administrators * QA managers plus personnel * QC as well as Lab managers * Validation companies * Regulatory extramarital affairs * Training sections * Documentation department * Consultants

Overview: All rules have got strict specifications with regard to digital diet facts and other e-records.

The target could be to ensure accuracy, integrity, authenticity, safety as well as accessibility with files through that full your life out of generation to deletion. While the intent is a same for all restrictions exclusively FDA's 21 years old CFR Part 11 plus the particular EU equivalent Annex eleven possess well defined needs nevertheless nevertheless leave a lot of living room regarding interpretations.

Reference material pertaining to quick implementation:

* SOP: Recording involving GLP plus GMP Raw Data. * SOP: Retention and Archiving of Electronic Records * Checklist: FDA Record Retention and Retrieval

Areas Covered inside the Session:

* FDA Requirements pertaining to raw records plus meta records * FDA Inspection as well as enforcement routines * Recommendations through marketplace task forces: GAMP/ISPE guides * Definition with raw data: primary records vs. typical digital formats, pieces of paper print-outs * Ensure along with display strength involving diet facts * The value associated with threat assessment to the management with diet data * Electronic track record preservation during archiving period of time * Software to manage and archive raw files and also other digital camera details * Data migration in order to new devices * Developing within a for consistent raw facts software * Examples from laboratories, offices and also manufacturing

Who Will Benefit:

* IT managers and also program directors * QA professionals plus personnel * QC in addition to Lab professionals * Validation specialists * Regulatory relationships * Training departments * Documentation department * Consultants