• eQMS Terms of Service

SoftComply eQMS Terms of Service

INTRODUCTION

We are SoftComply (registry code 14013101, located at Telliskivi Street 60, Tallinn, Harju County, 10412, Republic of Estonia), (hereinafter “SoftComply” ,“we”, “us” or “our”) a company established and existing under the laws of the Republic of Estonia, operating the www.softcomply.com website (hereinafter “Web Site”) and providing the Quality Management System (QMS) Software (hereinafter also “QMS Software”).

The QMS Software is intended for customers (hereinafter “customer”, “you” or “your”) who use Atlassian Confluence Server. The QMS Software helps you establish a quality management and provides a variety of processes which help describe how your organization carries out the development, distribution and maintenance activities in order to comply with applicable standards and regulations.

The Services made available by us are hereinafter referred to as “Services”. Making use of our Services requires you to obtain and maintain (at all times) a valid right to use the Atlassian Confluence Server (as described and currently available at https://www.atlassian.com/licensing/confluence).

These terms of service (hereinafter “Terms of Service”) apply to all persons who use the Services. By accepting these Terms of Service, you confirm that you have carefully read and understand these Terms of Service and you agree to be bound by these terms and policies referenced herein. Once accepted by you, the Terms of Service form a legally binding contract between you and SoftComply for using the QMS Software and the Services (hereinafter “Agreement”).

1. ACCESSING THE SERVICES

1.1. Our QMS Software is an Atlassian add–on. For accessing the QMS Software and the Services you would first need to become a user of Atlassian Confluence software. Once a user, you may now access our Services and start using our QMS Software, by ordering and installing the QMS software either via Atlassian Marketplace or our Web Site, as specified in clauses 1.2. and 1.3. below. By doing so you will also accept these Terms of Service which constitutes entering into a binding Agreement with us.

1.2. By becoming a registered user of Atlassian Marketplace (requires accepting terms of use available at https://www.atlassian.com/licensing/marketplace/termsofuse) you may order and install our QMS Software from Atlassian Marketplace available at https://marketplace.atlassian.com/ by following the installation and payment instructions indicated at Atlassian Marketplace.

1.3. You may also order and install the QMS Software via our Web Site by following the instructions indicated on the Web Site. Upon ordering through our Web Site, we will send you a license key to use the QMS Software within three (3) business days after payment of the fee pursuant to these Terms of Service.

1.4. If you are a natural person, then in order to enter into the Agreement, you must be at least 18 years of age or have a valid authorization from your legal representative or custodian. If you are a legal entity, you must be duly incorporated and have full legal capacity. If you are entering into the Agreement on behalf of a legal entity, such as your employer or the company you provide services to, you represent that you have the legal authority to bind that entity.

1.5. The Agreement is considered entered into as of accepting the Terms of Service. For avoidance of any doubt, you may not use the Services before you have accepted the Terms of Service.

1.6. The Agreement shall further extend to any new features, functions, enhancements and developments in the QMS Software and the Services, including the release of new tools.

2. RIGHTS GRANTED TO YOU

2.1. Subject to the Terms of Service, you are granted a limited non-exclusive license to use the Services and the QMS Software via Atlassian Confluence server software during the license term. The QMS Software (including all features of the QMS Software) is solely and exclusively owned and operated by us. Intellectual property rights, including, but not limited to, any and all copyrights, trademarks, service marks and trade names contained in the QMS Software, are owned by us, our affiliates and/or third-party licensors.

2.2. By the Services we provide you with tools and draft documentation that enables you to produce technical files required to receive clearance to distribute a device on a level of complexity required from a medical device, and to create and manage your Quality System for Medical Devices.

2.3. The Services are based on various standards and requirements, such as ISO 13485:2016, IEC 62304:2006 (as amended in 2008 and 2015), ISO 14971:2012 and 21 CFR 820. Depending on the complexity of your device or software and its classification, there may be additional or other measures needed to obtain CE mark (Europe) or FDA clearance (USA), or market clearance, in general, for other jurisdictions. There may also be other requirements to be fulfilled before you can enter the market. By using the Services, you may produce technical files relevant for the clearance but you are solely responsible that your software or your product, your documents and/or processes are in compliance with all the applicable laws and regulations, and that these are safe, reliable and compliant. We do not take the responsibility for providing the final, appropriate and suitable documents for any clearance or audit.

2.4. You are not allowed to lease the Services, the QMS Software and the features provided to you via the QMS Software, rent it or commercialise it in other way. You are also not allowed to provide third party access to the QMS Software or the Services. You understand that your use of the QMS Software or the Services does not grant you ownership of the QMS Software or the Services.

2.5. Once the QMS Software is deployed as a Confluence Space on your server, your content on this space will not be modified, maintained or accessed by SoftComply. You will be solely responsible for the implementation and maintenance of your data. Any update or change in QMS Software will not impact the content of your data. Macros provided as a part of the QMS Software may be modified in any update without prior notice, in the same way as any other Confluence macro provided by Atlassian or other add-ons.

2.6. Unless provided by applicable law, you shall not modify, translate, disassemble, decompile or re-engineer a part or the whole of the QMS Software. You shall not copy, distribute or publish any content of the QMS Software, unless provided by applicable law.

2.7. It is prohibited to:

2.7.1. use the QMS Software or the Services for any unlawful purpose;

2.7.2. solicit others to perform or participate in any unlawful acts;

2.7.3. violate any international or local regulations, rules and laws;

2.7.4. harass, abuse, insult, harm, defame, slander, disparage, intimidate, or discriminate based on gender, sexual orientation, religion, ethnicity, race, age, national origin, or disability;

2.7.5. submit any false or misleading information;

2.7.6. upload or transmit viruses or any other type of malicious code that will or may be used in any way that will affect the functionality or operation of the QMS Software or the Services;

2.7.7. spam, phish, pharm, pretext, spider, crawl, or scrape;

2.7.8. use the Services for any obscene or immoral purpose;

2.7.9. interfere with or circumvent the security features of the QMS Software or the Services or any related website, other websites, or the Internet;

2.7.10. use the QMS Software or the Services if you are not able to form legally binding contracts (for example if you are under 18 years old), or are temporarily or indefinitely suspended from using our sites, services, applications or tools;

2.7.11. circumvent any technical measures we use to provide the Services.

2.8. We do not guarantee that your use of the Services will always be uninterrupted, timely, secure or error-free. You understand that there might be occasions when the Service may be interrupted for an indefinite time period, including, without limitation, for scheduled maintenance or upgrades, for emergency repairs, or due to failure of telecommunications links and/or equipment.

2.9. We do not provide you any data storage service. You are solely responsible for your data storage. We may store your data in servers, including in cloud servers, but we are not responsible for retention of your data. You are responsible for making backup copies of your data and making sure that your data is retained.

2.10. We may, at any time, provide or make available updates or upgrades, including without limitation, bug fixes, service enhancements, new features, deletion of existing functions, or modifications. Updates will be governed by these Terms of Service, unless separate terms and conditions are provided with such updates, in which case that separate terms and conditions shall govern the updates.

2.11. We reserve the right to update, change or replace any part of the Terms of Service. We will notify you of such cases in the course of the provision of the Services. Your continued use of the QMS Software or the Services after posting of any changes constitutes acceptance of those changes.

2.12. We reserve the right to refuse to enter into the Agreement with a customer and to provide the Service (including but not limited to access to the QMS Software) on the basis of the objective justification at any time.

3. PRIVACY POLICY

3.1. For the provision of the Services, we may need to process information submitted by you, including some personal data (hereinafter “Personal Data”). This section incorporates our privacy policy (hereinafter “Privacy Policy”).

3.2. We collect and process only such data that is voluntarily submitted by you to us. We do not collect or process any other data about you.

3.3. We use Personal Data only for the purposes and to the extent that it is necessary for providing you with the Services.

3.4. We do not disclose Personal Data to any third parties, unless it is necessary to operate, maintain, enhance or provide features of the Services, to collect fees, to provide information that you request, to understand and analyse the usage trends and your preferences, to improve the QMS Software and the Services or to send communications.

3.5. We may transfer, process and store Personal Data in cloud databases that are located outside of Estonia. You represent your agreement to such processing and storage.

3.6. You have the right to access, amend, correct inconsistencies of or update any Personal Data, or request that we delete Personal Data obtained. We retain the Personal Data collected from you only during the term of the Agreement or as long as it is necessary for complying with the conditions of this Agreement.

3.7. We may use cookies, in compliance with the Atlassian Privacy Policy as currently available at https://www.atlassian.com/legal/privacy-policy. Cookies are small data files stored on your hard drive by a website. You can delete or block cookies through your browser settings at any time. However, some cookies might be necessary for the functionality of the Web Site, the QMS Software or the Services. For more general information about cookies including the difference between session and persistent cookies please see www.allaboutcookies.org.

3.8. Upon processing Personal Data we shall follow all applicable laws and regulations regarding the protection of personal data. You shall have all rights arising from applicable personal data legislation.

3.9. In case you have any question concerning the Privacy Policy or your Personal Data, please contact us info@softcomply.com.

4. LINKED SITES AND THIRD PARTY CONTENT

4.1. The Software and the Services are made available via Atlassian Marketplace. Atlassian may determine the availability of an Atlassian Marketplace add-on. Atlassian may stop a transaction, or restrict access to Services and Software. We are not responsible and do not bear any liability if your access to the Services is ceased or limited by Atlassian. In such case, all claims should be submitted directly to Atlassian.

4.2. The QMS Software and the Services may include links to other websites or services or to third party content. We do not endorse any such linked sites or third party content or the information, material, products, or services contained on or accessible through linked sites. Access and use of linked sites, including the information, material, products, and services on linked sites or available through linked sites is solely at your own risk.

4.3. Your compliance with the terms of Atlassian Confluence service is your own sole responsibility. We do not bear any responsibility for any of your violation of such terms, even if it has occurred in process of provision of our Services.

5. PAYMENT

5.1. The Services are subject to a yearly fee as an advance payment for each following one-year period. Fee may be payable via Atlassian Marketplace or Web Site, depending on your chosen access to the Services and the QMS Software.

5.2. For the Services accessed via Atlassian Marketplace, our fee for using the Services and the QMS Software shall be calculated on the basis of your users as indicated on the Atlassian Marketplace at https://marketplace.atlassian.com. Fee is charged in currency indicated on the Atlassian Marketplace (with relevant VAT information).

5.3. For acceptable payment methods upon paying via Atlassian Marketplace, please see the terms of and conditions of Atlassian Marketplace, licensing and purchasing information currently available at https://www.atlassian.com/licensing/purchase-licensing.

5.4. Expiration date for using the Services and the QMS Software is specified in your order made via Atlassian Marketplace. If you do not update your order before the expiration date, provision of the Services, including your access to updates and new versions of the Services and QMS Software, will be ceased at expiration. Without prejudice to the foregoing, the cease of provision of the Services will not affect your deployed QMS space (your data), it will remain on your Confluence server without the Services like macros, generating a new QMS space, etc.

5.5. For the Services accessed via our Web Site, our fee for using the Services and the QMS Software shall be calculated on the basis of your users as indicated on Web Site. We will send you an invoice for our fee to the e-mail address provided by you upon ordering. Our fee is charged in currency indicated on our Web Site (with relevant VAT information) and payable as advance payment for the one-year license period to our bank account indicated on the invoice within 7 days as of submitting the invoice.

5.6. Your right to use our Services and the QMS Software accessed via our Web Site will expire after the one year license period. For continued use we will send you a notification and subsequent invoice for our fee for the following one-year period before the expiration date. In such case, and provided our fee for the upcoming year is paid latest by the expiration date, your use of the Services and the QMS Software shall continue accordingly. If you do not pay our fee for the upcoming year by the expiration date, provision of the Services, including your access to updates and new versions of the Services and QMS Software, will be ceased at expiration. Without prejudice to the foregoing, the cease of provision of the Services will not affect your deployed QMS space (your data), it will remain on your Confluence server without the Services like macros, generating a new QMS space, etc.

5.7. Please note that we are entitled to change the applicable fee from time to time. Please see Atlassian Marketplace (upon ordering via Atlassian Marketplace) or our Web Site (upon ordering via our Web Site) for currently applicable fees.

5.8. Upon delay with any payments, you are obliged to pay interest on the delay (penalty for late payment) in amount of 0.05% per day for each day in delay.

6. TERM AND TERMINATION

6.1. The Agreement is concluded without a term.

6.2. Both you and we have right to ordinary cancellation of the Agreement, by serving the other party a thirty (30) days prior notice. Upon termination of this Agreement, no advance payments will be refunded.

6.3. We are entitled to terminate the Agreement extraordinarily if you have materially violated the Agreement or have not remedied any violation within 10 (ten) days after being notified by us.

7. LIABILITY AND IDEMNIFICATION

7.1. The QMS Software, the Services and any content, or the services or the features made available in conjunction with or through the QMS Software or the Services is provided “as is” and “as available” without any warranties of any kind either express or implied. To the fullest extent permissible pursuant to applicable law, we disclaim all warranties.

7.2. We do not warrant or guarantee that the Services will be compatible with all or any hardware and the QMS Software which you may use, available all the time or at any specific time, uninterrupted, secure or error free, suitable for your requirements or free from viruses, interference, hacking or other security intrusion.

7.3. Including, but not limited to, we shall not be responsible for the following:

7.3.1. any permanent or temporary interruption, discontinuance, suspension or other type of unavailability of the QMS Software or the Services;

7.3.2. any interruption or cessation of transmission to or from the QMS Software or the Services;

7.3.3. any bugs, viruses, Trojan horses or the like, which may be transmitted to or through the QMS Software or the Services;

7.3.4. any decision made or any action taken by you in reliance of the data or recommendations provided by us;

7.3.5. deletion of, corruption of, or failure to store any content or data;

7.3.6. any disclosure, loss or unauthorized use of the login credentials due to Customer’s failure to keep such credentials confidential;

7.3.7. the incompatibility of technologies used for accessing the QMS Software and the Services, for example if certain features, functions, parts or elements of the Services are designed for use on a personal computer or laptop and do not function on a mobile device or a tablet.

7.4. You understand and confirm that all decisions made by you relying on any information obtained by using the QMS Software and the Services, including the decisions regarding Software or device, are your own full responsibility. We will not be liable for any decision made by you upon your use of the Services.

7.5. We are not liable for any violation of law by you in front of any third persons. We do not take responsibility for safety, compliance and serviceability of your software or device.

7.6. You agree to indemnify us, our partners and sub-contractors engaged in provision of the Services against any costs, damage, claims (including but not limited to claims of third parties), liabilities and expenses incurred as a result of Customer’s violation of this Agreement, any provisions of the applicable law or provisions of third party contract.

7.7. In any case, our liability for violation of this Agreement shall be limited to the monthly fee actually paid to us for the Services provided hereunder. The limitation is not applied in case of wilful breach of this Agreement.

7.8. We shall not be liable to you for anything that is the result of any events beyond our reasonable control ( “Force Majeure”), including, but not limited to, acts of nature, storm, fire, earthquake, explosion, flood, war, insurrection, riots, terrorism, crime, labor shortages and strikes, lockout or other industrial action, embargoes, terrorism, crime, the weather and climate conditions, default or failure of a third party, electrical failure, confiscation and action or threat of action of any government or government agency.

8. GOVERNING LAW AND JURISDICTION

8.1. These Terms of Service shall be governed by the laws of the Republic of Estonia.

8.2. Any disputes arising from these Terms of Service shall be settled in the Harju County Court in the Republic of Estonia.

9. MISCELLANEOUS

9.1. If any term, condition or provision of these Terms of Service is held to be invalid, unenforceable or illegal in whole or in part for any reason, that provision shall be enforced to the maximum extent permissible. The validity and enforceability of the remaining terms, conditions or provisions, or portions of them, shall not be affected.

9.2. Our failure to exercise or enforce any provision of or any of our rights under these Terms of Service shall not mean that we have deemed a waiver of future enforcement of that or any other provision or right.

By purchasing the product, you confirm that you have carefully read and understand all terms set forth above and you agree with the Terms of Service.