Winsteps.com (Winsteps and Facets software) Compliance Report: FDA 21 CFR Part 11 / EU Annex 11

Winsteps and Facets are computational software and are both becoming more integrated with R Statistics, Excel and Graphical software to support their input and output functions. Winsteps and Facets themselves input and output simple text files. They maintain no history, records nor database. For compliance:
R Statistics: www.r-project.org/doc/R-FDA.pdf
Excel: https://learn.microsoft.com/en-us/compliance/regulatory/offering-fda-cfr-title-21-part-11

The statistical publisher SAS discusses the issue of mathematical software components in larger systems in www.sas.com/content/dam/SAS/documents/marketing-whitepapers-ebooks/sas-whitepapers/en/quality-imperative-commitment-to-quality-106810.pdf Though SAS publishes much more comprehensive software with much greater development resources, the principles of what they write in their Appendix 1. "Regulated Industry Issues" and Appendix 2. "Validating an Analytical Component" apply also to Winsteps and Facets.


Winsteps.com (Winsteps and Facets software) Privacy Policy

Winsteps.com respect your privacy and are committed to protecting it through our compliance with this privacy policy (“Policy”). This Policy describes the types of information we may collect from you or that you may provide (“Personal Information”) in the “Winsteps” or “Facets” Desktop application (“Desktop Application” or “Service”) and any of its related products and services (collectively, “Services”), and our practices for collecting, using, maintaining, protecting, and disclosing that Personal Information. It also describes the choices available to you regarding our use of your Personal Information and how you can access and update it.

This Policy is a legally binding agreement between you (“User”, “you” or “your”) and Winsteps.com (“Winsteps.com”, “we”, “us” or “our”). If you are entering into this Policy on behalf of a business or other legal entity, you represent that you have the authority to bind such entity to this Policy, in which case the terms “User”, “you” or “your” shall refer to such entity. If you do not have such authority, or if you do not agree with the terms of this Policy, you must not accept this Policy and may not access and use the Desktop Application and Services. By accessing and using the Desktop Application and Services, you acknowledge that you have read, understood, and agree to be bound by the terms of this Policy. This Policy does not apply to the practices of companies that we do not own or control, or to individuals that we do not employ or manage.

Table of contents

  1. Collection of information
  2. Privacy of children
  3. Use and processing of collected information
  4. Disclosure of information
  5. Retention of information
  6. Social media features
  7. Email marketing
  8. Links to other resources
  9. Information security
  10. Data breach
  11. Changes and amendments
  12. Acceptance of this policy
  13. Contacting us

Collection of information

Our top priority is customer data security and, as such, we exercise the no logs policy. We may process only minimal user data, only as much as it is absolutely necessary to maintain the Desktop Application and Services. Information collected automatically is used only to identify potential cases of abuse and establish statistical information regarding the usage of the Desktop Application and Services. This statistical information is not otherwise aggregated in such a way that would identify any particular user of the system.

Privacy of children

We do not knowingly collect any Personal Information from children under the age of 18. If you are under the age of 18, please do not submit any Personal Information through the Desktop Application and Services. If you have reason to believe that a child under the age of 18 has provided Personal Information to us through the Desktop Application and Services, please contact us to request that we delete that child’s Personal Information from our Services.

We encourage parents and legal guardians to monitor their children’s Internet usage and to help enforce this Policy by instructing their children never to provide Personal Information through the Desktop Application and Services without their permission. We also ask that all parents and legal guardians overseeing the care of children take the necessary precautions to ensure that their children are instructed to never give out Personal Information when online without their permission.

Use and processing of collected information

We act as a data controller and a data processor when handling Personal Information, unless we have entered into a data processing agreement with you in which case you would be the data controller and we would be the data processor.

Our role may also differ depending on the specific situation involving Personal Information. We act in the capacity of a data controller when we ask you to submit your Personal Information that is necessary to ensure your access and use of the Desktop Application and Services. In such instances, we are a data controller because we determine the purposes and means of the processing of Personal Information.

We act in the capacity of a data processor in situations when you submit Personal Information through the Desktop Application and Services. We do not own, control, or make decisions about the submitted Personal Information, and such Personal Information is processed only in accordance with your instructions. In such instances, the User providing Personal Information acts as a data controller.

In order to make the Desktop Application and Services available to you, or to meet a legal obligation, we may need to collect and use certain Personal Information. If you do not provide the information that we request, we may not be able to provide you with the requested products or services. Any of the information we collect from you may be used for the following purposes:

Processing your Personal Information depends on how you interact with the Desktop Application and Services, where you are located in the world and if one of the following applies: (i) you have given your consent for one or more specific purposes; (ii) provision of information is necessary for the performance of this Policy with you and/or for any pre-contractual obligations thereof; (iii) processing is necessary for compliance with a legal obligation to which you are subject; (iv) processing is related to a task that is carried out in the public interest or in the exercise of official authority vested in us; (v) processing is necessary for the purposes of the legitimate interests pursued by us or by a third party.

Note that under some legislations we may be allowed to process information until you object to such processing by opting out, without having to rely on consent or any other of the legal bases. In any case, we will be happy to clarify the specific legal basis that applies to the processing, and in particular whether the provision of Personal Information is a statutory or contractual requirement, or a requirement necessary to enter into a contract.

Disclosure of information

Depending on the requested Services or as necessary to complete any transaction or provide any Service you have requested, we may share your information with our affiliates, contracted companies, and service providers (collectively, “Service Providers”) we rely upon to assist in the operation of the Desktop Application and Services available to you and whose privacy policies are consistent with ours or who agree to abide by our policies with respect to Personal Information. We will not share any personally identifiable information with third parties and will not share any information with unaffiliated third parties.

Service Providers are not authorized to use or disclose your information except as necessary to perform services on our behalf or comply with legal requirements. Service Providers are given the information they need only in order to perform their designated functions, and we do not authorize them to use or disclose any of the provided information for their own marketing or other purposes.

We may also disclose any Personal Information we collect, use or receive if required or permitted by law, such as to comply with a subpoena or similar legal process, and when we believe in good faith that disclosure is necessary to protect our rights, protect your safety or the safety of others, investigate fraud, or respond to a government request.

Retention of information

We will retain and use your Personal Information for the period necessary to comply with our legal obligations, to enforce our Policy, resolve disputes, and unless a longer retention period is required or permitted by law.

We may use any aggregated data derived from or incorporating your Personal Information after you update or delete it, but not in a manner that would identify you personally. Once the retention period expires, Personal Information shall be deleted. Therefore, the right to access, the right to erasure, the right to rectification, and the right to data portability cannot be enforced after the expiration of the retention period.

Social media features

Our Desktop Application and Services may include social media features, such as the Facebook and Twitter buttons, Share This buttons, etc (collectively, “Social Media Features”). These Social Media Features may collect your IP address, what page you are visiting on our Desktop Application and Services, and may set a cookie to enable Social Media Features to function properly. Social Media Features are hosted either by their respective providers or directly on our Desktop Application and Services. Your interactions with these Social Media Features are governed by the privacy policy of their respective providers.

Email marketing

We offer electronic newsletters to which you may voluntarily subscribe at any time. We are committed to keeping your e-mail address confidential and will not disclose your email address to any third parties except as allowed in the information use and processing section or for the purposes of utilizing a third-party provider to send such emails. We will maintain the information sent via e-mail in accordance with applicable laws and regulations.

In compliance with the CAN-SPAM Act, all e-mails sent from us will clearly state who the e-mail is from and provide clear information on how to contact the sender. You may choose to stop receiving our newsletter or marketing emails by following the unsubscribe instructions included in these emails or by contacting us.

The Desktop Application and Services contain links to other resources that are not owned or controlled by us. Please be aware that we are not responsible for the privacy practices of such other resources or third parties. We encourage you to be aware when you leave the Desktop Application and Services and to read the privacy statements of each and every resource that may collect Personal Information.

Information security

We secure information you provide on computer servers in a controlled, secure environment, protected from unauthorized access, use, or disclosure. We maintain reasonable administrative, technical, and physical safeguards in an effort to protect against unauthorized access, use, modification, and disclosure of Personal Information in our control and custody. However, no data transmission over the Internet or wireless network can be guaranteed.

Therefore, while we strive to protect your Personal Information, you acknowledge that (i) there are security and privacy limitations of the Internet which are beyond our control; (ii) the security, integrity, and privacy of any and all information and data exchanged between you and the Desktop Application and Services cannot be guaranteed; and (iii) any such information and data may be viewed or tampered with in transit by a third party, despite best efforts.

Data breach

In the event we become aware that the security of the Desktop Application and Services has been compromised or Users’ Personal Information has been disclosed to unrelated third parties as a result of external activity, including, but not limited to, security attacks or fraud, we reserve the right to take reasonably appropriate measures, including, but not limited to, investigation and reporting, as well as notification to and cooperation with law enforcement authorities. In the event of a data breach, we will make reasonable efforts to notify affected individuals if we believe that there is a reasonable risk of harm to the User as a result of the breach or if notice is otherwise required by law. When we do, we will send you an email.

Changes and amendments

We reserve the right to modify this Policy or its terms related to the Desktop Application and Services at any time at our discretion. When we do, we will revise the updated date at the bottom of this page, send you an email to notify you. We may also provide notice to you in other ways at our discretion, such as through the contact information you have provided.

An updated version of this Policy will be effective immediately upon the posting of the revised Policy unless otherwise specified. Your continued use of the Desktop Application and Services after the effective date of the revised Policy (or such other act specified at that time) will constitute your consent to those changes. However, we will not, without your consent, use your Personal Information in a manner materially different than what was stated at the time your Personal Information was collected.

Acceptance of this policy

You acknowledge that you have read this Policy and agree to all its terms and conditions. By accessing and using the Desktop Application and Services and submitting your information you agree to be bound by this Policy. If you do not agree to abide by the terms of this Policy, you are not authorized to access or use the Desktop Application and Services. This privacy policy has been created with the help of the privacy policy generator.

Contacting us

If you have any questions, concerns, or complaints regarding this Policy, the information we hold about you, or if you wish to exercise your rights, we encourage you to contact us using the details below:

https://www.winsteps.com/index.htm
support@winsteps.com

We will attempt to resolve complaints and disputes and make every reasonable effort to honor your wish to exercise your rights as quickly as possible and in any event, within the timescales provided by applicable data protection laws.

This document was last updated on October 5, 2023

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Rasch, Winsteps, Facets online Tutorials

 

Facets Rasch measurement software. Buy for $149. & site licenses. Freeware student/evaluation Minifac download
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Rasch Books and Publications: Winsteps and Facets
Applying the Rasch Model (Winsteps, Facets) 4th Ed., Bond, Yan, Heene Advances in Rasch Analyses in the Human Sciences (Winsteps, Facets) 1st Ed., Boone, Staver Advances in Applications of Rasch Measurement in Science Education, X. Liu & W. J. Boone Rasch Analysis in the Human Sciences (Winsteps) Boone, Staver, Yale Appliquer le modèle de Rasch: Défis et pistes de solution (Winsteps) E. Dionne, S. Béland
Introduction to Many-Facet Rasch Measurement (Facets), Thomas Eckes Rasch Models for Solving Measurement Problems (Facets), George Engelhard, Jr. & Jue Wang Statistical Analyses for Language Testers (Facets), Rita Green Invariant Measurement with Raters and Rating Scales: Rasch Models for Rater-Mediated Assessments (Facets), George Engelhard, Jr. & Stefanie Wind Aplicação do Modelo de Rasch (Português), de Bond, Trevor G., Fox, Christine M
Exploring Rating Scale Functioning for Survey Research (R, Facets), Stefanie Wind Rasch Measurement: Applications, Khine Winsteps Tutorials - free
Facets Tutorials - free
Many-Facet Rasch Measurement (Facets) - free, J.M. Linacre Fairness, Justice and Language Assessment (Winsteps, Facets), McNamara, Knoch, Fan
Other Rasch-Related Resources: Rasch Measurement YouTube Channel
Rasch Measurement Transactions & Rasch Measurement research papers - free An Introduction to the Rasch Model with Examples in R (eRm, etc.), Debelak, Strobl, Zeigenfuse Rasch Measurement Theory Analysis in R, Wind, Hua Applying the Rasch Model in Social Sciences Using R, Lamprianou El modelo métrico de Rasch: Fundamentación, implementación e interpretación de la medida en ciencias sociales (Spanish Edition), Manuel González-Montesinos M.
Rasch Models: Foundations, Recent Developments, and Applications, Fischer & Molenaar Probabilistic Models for Some Intelligence and Attainment Tests, Georg Rasch Rasch Models for Measurement, David Andrich Constructing Measures, Mark Wilson Best Test Design - free, Wright & Stone
Rating Scale Analysis - free, Wright & Masters
Virtual Standard Setting: Setting Cut Scores, Charalambos Kollias Diseño de Mejores Pruebas - free, Spanish Best Test Design A Course in Rasch Measurement Theory, Andrich, Marais Rasch Models in Health, Christensen, Kreiner, Mesba Multivariate and Mixture Distribution Rasch Models, von Davier, Carstensen
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Questions, Suggestions? Want to update Winsteps or Facets? Please email Mike Linacre, author of Winsteps mike@winsteps.com


State-of-the-art : single-user and site licenses : free student/evaluation versions : download immediately : instructional PDFs : user forum : assistance by email : bugs fixed fast : free update eligibility : backwards compatible : money back if not satisfied
 
Rasch, Winsteps, Facets online Tutorials

Coming Rasch-related Events
May 17 - June 21, 2024, Fri.-Fri. On-line workshop: Rasch Measurement - Core Topics (E. Smith, Winsteps), www.statistics.com
June 12 - 14, 2024, Wed.-Fri. 1st Scandinavian Applied Measurement Conference, Kristianstad University, Kristianstad, Sweden http://www.hkr.se/samc2024
June 21 - July 19, 2024, Fri.-Fri. On-line workshop: Rasch Measurement - Further Topics (E. Smith, Winsteps), www.statistics.com
Aug. 5 - Aug. 7, 2024, Mon.-Wed. 2024 Inaugural Conference of the Society for the Study of Measurement (Berkeley, CA), Call for Proposals
Aug. 9 - Sept. 6, 2024, Fri.-Fri. On-line workshop: Many-Facet Rasch Measurement (E. Smith, Facets), www.statistics.com
Oct. 4 - Nov. 8, 2024, Fri.-Fri. On-line workshop: Rasch Measurement - Core Topics (E. Smith, Winsteps), www.statistics.com
Jan. 17 - Feb. 21, 2025, Fri.-Fri. On-line workshop: Rasch Measurement - Core Topics (E. Smith, Winsteps), www.statistics.com
May 16 - June 20, 2025, Fri.-Fri. On-line workshop: Rasch Measurement - Core Topics (E. Smith, Winsteps), www.statistics.com
June 20 - July 18, 2025, Fri.-Fri. On-line workshop: Rasch Measurement - Further Topics (E. Smith, Facets), www.statistics.com
Oct. 3 - Nov. 7, 2025, Fri.-Fri. On-line workshop: Rasch Measurement - Core Topics (E. Smith, Winsteps), www.statistics.com

 

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