Discover a new level of Data Safety for Automation Technology in line with ISO 900x and FDA 21 CFR 11 Discover a new level of Data Safety for Automation.

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Presentation transcript:

Discover a new level of Data Safety for Automation Technology in line with ISO 900x and FDA 21 CFR 11 Discover a new level of Data Safety for Automation Technology

Page 2 of 33 What do we gain by this? What are the Benefits? Benefits

Page 3 of 33 Quality improvement due to VersionWorks ® Benefits Quality improvement due to VersionWorks ® Complete version control and archiving of all data and software releases as a foundation for “disaster recovery” Exact reproduceable production conditions Association and traceability of software releases and product batches Secure user and access administration Electronic signature for all relevant actions Documented change process and audit trail in line with ISO 900x and FDA 21 CFR 11 Automated change check and reporting

Page 4 of 33 Cost reduction due to VersionWorks ® Benefits Cost reduction due to VersionWorks ® Reduction of production down time Prevention of down time and bad product, due to accidentally activated old software Prevention of financial loss, due to loss of vital data Prevention of loss of know-how, due to personnel changes/movement Quick training of new personnel Time saving for the searching of valid Software releases Extreme improvement of daily procedures and routines Short amortization time (ROI)

Page 5 of 33 BIConsulting Inc. Miami, USA 9050 Pines Blvd. Suite 480 Pembroke Pines, FL Tel.: +1 (954) Fax.: +1 (954) Contact Us