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Software Engineering Process Technology (SEPT)
Software Engineering Process Technology Company, (SEPT) is a firm specializing in meeting the software standards information needs of the professional community, particularly concerning ISO/IEC 12207. SEPT provides standards information via books, checklists, reports, and consulting.Environment & Health protection
FDA Audit, Validation & Documentation
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Electronic Signatures; Final Rule-FDA 21CFR Part 11
Price: $330 -
Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices As amended by Guidance for Industry, FDA Reviewers and Compliance on Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
Price: $167 -
ISO 13485:2016 “Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes”
Price: $330 -
Evidence Product Checklist For UL 1998 Standard for Safety - Software in Programmable Components
Price: $330
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Electronic Signatures; Final Rule-FDA 21CFR Part 11
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IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
Price: $167 -
Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices.
Price: $167 -
FDA, General Principles of Software Validation Final Guidance for Industry and FDA Staff (Release date January 11, 2002)
Price: $330 -
ISO 14971:2019 Medical devices - Application of Risk Management to Medical Devices
Price: $330
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IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
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Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices As amended by Guidance for Industry, FDA Reviewers and Compliance on Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
Price: $330 -
Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices.
Price: $330 -
Electronic Signatures; Final Rule-FDA 21CFR Part 11
Price: $167 -
FDA, General Principles of Software Validation Final Guidance for Industry and FDA Staff (Release date January 11, 2002)
Price: $167
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Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices As amended by Guidance for Industry, FDA Reviewers and Compliance on Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
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ISO 13485:2016 “Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes”
Price: $167 -
Evidence Product Checklist For UL 1998 Standard for Safety - Software in Programmable Components
Price: $167 -
Checklist for applying IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
Price: $330 -
ISO 14971:2019 Medical devices - Application of Risk Management to Medical Devices
Price: $167
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ISO 13485:2016 “Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes”
IT and PCI Compliance
View more
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ISO/IEC/IEE Standard 15288:2015-Systems and Software Engineering-System Life Cycle Processes - (Third Edition)
Price: $330 -
A Software Engineering Kit – Composed of Templates for Key Software Engineering Process Plans
Price: $298 -
ISO/IEC/IEE Standard 15288:2015-Systems and Software Engineering-System Life Cycle Processes - (Third Edition)
Price: $167 -
Checklist for Standard ISO/IEC 27002:2013 - Information Security Code of Practice
Price: $167
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ISO/IEC/IEE Standard 15288:2015-Systems and Software Engineering-System Life Cycle Processes - (Third Edition)
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Template for a Software Maintenance Plan - Fifth Edition
Price: $149 -
Evidence Product Checklist for ISO/IEC 12207:2017 ''System and Software Engineering - Software Life Cycle Processes''
Price: $167 -
Templates and Plans for Software Configuration Management Documents-Version 6.0
Price: $149 -
Software Documentation Management Plan Template - Second Edition
Price: $149
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Template for a Software Maintenance Plan - Fifth Edition
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System Documentation Management Plan Template- Second Edition
Price: $149 -
ISO/IEC 42010:2011 Systems and Software Engineering - Architecture Description
Price: $330 -
ISO/IEC 42010:2011 Systems and Software Engineering - Architecture Description
Price: $167 -
Checklist for Standard ISO/IEC 27001:2013 - Information Security Requirements
Price: $167
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System Documentation Management Plan Template- Second Edition
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Checklist for Standard ISO/IEC 27018:2014
Price: $167 -
ISO/IEC 27000 Checklist Kit
Price: $250 -
Guide to Software Engineering Standards and Specifications 1
Price: $30 -
Guide to Software Engineering Standards and Specifications 2
Price: $30
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Checklist for Standard ISO/IEC 27018:2014
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Guide to Software Engineering Standards and Specifications 3
Price: $30 -
Configuration, Acronyms & Abbreviations in Technical Writing
Price: $25 -
Checklist for Standard ISO/IEC 27002:2013 - Information Security Code of Practice
Price: $399 -
System Documentation Management Plan Template- Second Edition
Price: $330
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Guide to Software Engineering Standards and Specifications 3
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Template for a Software Maintenance Plan - Fifth Edition
Price: $330 -
Software Documentation Management Plan Template - Second Edition
Price: $330 -
Templates and Plans for Software Configuration Management Documents-Version 6.0
Price: $330 -
A Software Engineering Kit – Composed of Templates for Key Software Engineering Process Plans
Price: $660
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Template for a Software Maintenance Plan - Fifth Edition
Medical Device and Healthcare Technology
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Electronic Signatures; Final Rule-FDA 21CFR Part 11
Price: $330 -
Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices As amended by Guidance for Industry, FDA Reviewers and Compliance on Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
Price: $167 -
ISO 13485:2016 “Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes”
Price: $330 -
Evidence Product Checklist For UL 1998 Standard for Safety - Software in Programmable Components
Price: $330
-
Electronic Signatures; Final Rule-FDA 21CFR Part 11
-
-
IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
Price: $167 -
Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices.
Price: $167 -
FDA, General Principles of Software Validation Final Guidance for Industry and FDA Staff (Release date January 11, 2002)
Price: $330 -
ISO 14971:2019 Medical devices - Application of Risk Management to Medical Devices
Price: $330
-
IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
-
-
Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices As amended by Guidance for Industry, FDA Reviewers and Compliance on Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
Price: $330 -
Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices.
Price: $330 -
Electronic Signatures; Final Rule-FDA 21CFR Part 11
Price: $167 -
FDA, General Principles of Software Validation Final Guidance for Industry and FDA Staff (Release date January 11, 2002)
Price: $167
-
Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices As amended by Guidance for Industry, FDA Reviewers and Compliance on Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
-
-
ISO 13485:2016 “Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes”
Price: $167 -
Evidence Product Checklist For UL 1998 Standard for Safety - Software in Programmable Components
Price: $167 -
Checklist for applying IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
Price: $330 -
ISO 14971:2019 Medical devices - Application of Risk Management to Medical Devices
Price: $167
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ISO 13485:2016 “Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes”
Quality Terminologies & Documentations
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ISO/IEC/IEEE 90003:2018 "Software Engineering: Guidelines for the application of ISO 9001:2015 to computer software"
Price: $330 -
A Checklist for Assessing Software Supplier Compliance with ISO/IEC 90003:2014
Price: $167 -
ISO 9001:2015 ''Quality Management Systems - Requirements 2015 Edition''
Price: $167 -
Checklist for Standard ISO 9004:2018
Price: $167
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ISO/IEC/IEEE 90003:2018 "Software Engineering: Guidelines for the application of ISO 9001:2015 to computer software"
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ISO/IEC 20000-1:2011 “Information Technology – Service Management –Part 1: Service Management System Requirements”
Price: $167 -
Checklist for ISO 14001:2015 - Environmental Management Systems - Requirements with Guidance for Use
Price: $330 -
Checklist for ISO 14001:2015 - Environmental Management Systems - Requirements with Guidance for Use
Price: $167 -
ISO 9001:2015 ''Quality Management Systems - Requirements 2015 Edition''
Price: $330
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ISO/IEC 20000-1:2011 “Information Technology – Service Management –Part 1: Service Management System Requirements”
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ISO/IEC/IEEE 90003:2018 "Software Engineering: Guidelines for the application of ISO 9001:2015 to computer software"
Price: $167 -
A Checklist for Assessing Software Supplier Compliance with ISO/IEC 90003:2014
Price: $330 -
ISO/IEC 20000-1:2011 “Information Technology – Service Management –Part 1: Service Management System Requirements”
Price: $330 -
Checklist for Standard ISO 9004:2018
Price: $330
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ISO/IEC/IEEE 90003:2018 "Software Engineering: Guidelines for the application of ISO 9001:2015 to computer software"
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Product Feedback
ComplianceOnline always has Conferences available to keep me informed on changes to regulatory guidences. Steven is great presenter. He engage the group to discuss the topics in the presentation.
- Sr. Mfg ManagerFibroGen Inc.
Your Customer care services were extremely helpful. Thanks!
- Operations Program ManagerAbbott
I would like to Thanks to ComplianceOnline for coordinating this seminar and selecting good speaker. He was connected to subject with good example selection and material.
- Business Unit ManagerJAMAK
ComplianceOnline always has Conferences available to keep me informed on changes to regulatory guidences. Steven is great presenter. He engage the group to discuss the topics in the presentation.
- Sr. Mfg ManagerFibroGen Inc.
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