Security concept PCS 7 and WinCC - Basic document Whitepaper, 04/2008, A5E02128732-01 5 1 Preface 1 1 Validity "Security Concept PCS 7 and WinCC" incrementally replaces prior documents and recommendations "Security Concept PCS 7" und "Security Concept WinCC", both in Version 1, and is valid as of WinCC V6 2 and PCS 7 V7 0 or later
No part of this document may be reproduced except as authorized by written permission The copyright and the foregoing restriction extend to reproduction in all media
2 Chapter "Meeting the Requirements with SIMATIC WinCC (TIA Portal) (Page 9)" introduces the functionality of SIMATIC WinCC (TIA Portal) V15 to meet those requirements 3 Chapter "Evaluation List for SIMATIC WinCC (TIA Portal) (Page 17)" contains a detailed system assessment on the basis of the individual requirements of the relevant regulations
WinCC is indeed a family of products that can be fitted and assembled to provide the capabilities needed for any specific situation ¢ WinCC V7 3 is the main platform and has been evolving over the last 20 years Most recent refinements have been additions to make it function seamlessly with TIA Portal
WinCC flexible Runtime Describes how to commission and operate your runtime project on a PC Communication – Communication Part 1 describes the connection of the HMI device to SIMATIC PLCs – Communication Part 2 describes the connection of the HMI device to third-party PLCs Getting started WinCC flexible for first time users
HMI x WinCC / WinCC Flexible x intouch Part IV: Logic Part II: Libraries Part III: Geometry Version 1 1 released as Whitepaper at Hannover Messe 2009
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WinCC Advanced V14 SP1 - Options
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WIN CC promo leaflet - Siemens
drawn up by, among others, the FDA in 21 CFR Part11 Applying these guidelines accurately is essential for government and institutional approval SIMATIC WinCC has the right options for you to easily comply with all these regulations Tracing operator inputs and project changes using Audit Trails www siemens com/wincc € 3300 Till 30 September 2010
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THE ULTIMATE GUIDE TO 21 CFR PART 11 - Perficient
• CFR: Short for “Code of Federal Regulations,” which is a coded (numbers and letters) set of laws published by the federal government of the United States • Part 11: Scope is specific to electronic records and electronic signatures, which includes electronic submissions to the FDA The CFR is organized like this: Title > Chapter >
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FDA 21 CFR Part 11 Electronic records and signatures
and storage compared to traditional paper records, as well as increased security, traceability and transferability of data It is not just in the manufacturing (GMP) area that electronic data handling offers noteworthy benefits The amount of data generated in analytical laboratories operation under GLP is significant, and since this data requires review and approval signatures, 21 CFR Part 11
SIMATIC WinCC (TIA Portal) V13 – Compliance Response ERES 1 21 CFR Part 11 Electronic Records; Electronic Signatures, US FDA, March 20th 1997
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CHAMBERS – ACIC 21 CFR PART 11 WHITEPAPER WINCC SIEMENS UPDATESTAR IS COMPATIBLE UPDATESTAR HAS BEEN TESTED TESTING
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SIMATIC WinCC (TIA Portal) Runtime conforming to FDA 21 CFR Part 11, and multiple languages for Information on FDA can be found in a White Paper:
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WinCC/WebNavigator – Operator control and monito- ring via the per 21 CFR Part 11 in the pharmaceutical industry, the manu- mented in a White Paper
SIEMENS WinCC Datasheet