T&C

General term and conditions

Hello, and welcome to the website where you can learn the basic rules for using our service, VigiDirect. 

1. Who are we? 

• Company: QMFocus, s.r.o. 
• Registered office: Slanska 195, Velvary, Czech Republic
• ID: 05391814
• TAX-ID: CZ05391814
• Contact:
  • E-mail: PHV@qmfocus.com
  • Phone number: +420 602 690 617

2. Why do we have these general terms and conditions (T&C)? 

• We understand that reading T&C isn't the most exciting activity, but it's necessary to define the rules of conduct for both of us: Ourselves as service and product providers, and you as service recipients.  

• By making a purchase on PHV@qmfocus.com, you enter into a contract with QMFocus, s.r.o. These general terms and conditions define the content of this contract. 

• These T&C apply to all products and services provided in connection with the use of the website vigidirect.com. 

• Individual agreements take precedence over the general terms and conditions.

3. Who is VigiDirect designed for?  

• Whether you're a small business, a bigger corporation, or any other type of organization, we’d love to connect with you! Feel free to reach out via email, WhatsApp, or give us a call. Please note, all offerings in our online shop are strictly available to corporate entities and not to private individuals.  

4. What does VigiDirect offer to you? 

• Products
  1. Templates,
  2. Trainings.
• Services
  1. One-time,
  2. Frequent/repeated.

5.  When and how exactly do you agree with our T&C and enter into the contract? 

• You agree with these T&C by clicking at the icon providing the final order (“Order with obligation to pay“ or other similar text), or agree with order via e-mail. 

6. How can you shop in VigiDirect? 

• If you shop via e-shop web address: vigidirect.com:
  1. Your order will be proceeded after clicking on the final order (“Order with obligation to pay“ or other similar text).
  2. Our e-shop is online and accessible around-the-clock, unless unexpected circumstances arise that we are unable to influence. 
• If you shop via e-mail order:
  1. You may also order products and services via e-mail: PHV@qmfocus.com: 
     • Ordering via e-mail can also be used for any additional arrangements.
     • In the case of ordering via e-mail, the contract is concluded at the moment the order confirmation is delivered to your e-mail. We will not send the order confirmation before your full payment is proceeded.

7. Do we accept all of your orders?

• We are always happy to support you and deliver the service/product you need.  However, we retain the right to refuse an order. In such a case, we will immediately contact you and refund 100% of your payment after our expenses.  

8. How will be the service/product delivered to you? 

• The methods, terms, and prices of individual deliveries can be found in the description of individual products/services. VigiDirect describes only standard delivery methods. These methods can be changed on the client's request.

 9. Can you resell our products? 

• If you sell or gift the purchased products or services (or otherwise transfer ownership of the goods), both you and the new owner must inform us about this. If you fail to do so, we will consider you, as the original buyer, to be the owner of the products or services (e.g., we will handle complaints with you, and in the case of a refund, the money will be returned to you). 

 10. Cancellation rights 

• There is no cancellation right because all products and services are for business clients only. However, if a transaction occurs without the delivery of the product or service on our part, you may cancel the order, and 100% of the paid amount will be refunded. For services, you can terminate the collaboration at any time (more information in point 11), unless you have entered into an individual agreement with us containing other specific conditions. 

 11. How can you stop using the ordered services? 

• You can send us an e-mail to PHV@qmfocus.com and the service will be stopped within 1 business day or the day provided in your e-mail, unless you have entered into an individual agreement with us containing other specific conditions. 
• The provision of the service will also be terminated if you get into delay with your payment after 7 calendar days from the scheduled payment date (the scheduled payment day is considered as Day 0).

 12. How can you pay? 

• You can pay by online payment (transfer/credit card). 
• You can choose the payment method during product/service ordering.
• You will be sent a proforma invoice in case the product/service is not provided on the day of ordering. 
• If you fall into arrears with any full or partial payment, your unpaid order will be cancelled/your unpaid service will be terminated after 7 calendar days (the scheduled payment day is considered as Day 0). 

13. What Does Data Protection and Archiving Mean to Us? 

• The transmission of information over the internet is inherently not completely secure. While we make every reasonable effort to safeguard your data using industry-standard technological measures, we cannot guarantee its absolute security during transmission to our site; you assume this risk when transmitting information. However, once your data is received, we implement strict procedures and robust security measures to prevent unauthorized access. 
• We only have access to the data and information you provide to us directly. We do not make any effort to collect any other data or information from you.
• If you provide us with information about a third party, it is your responsibility to inform that person/company.
• We use your data for the following purposes: providing ordered products and services, and customer care, regulatory requirements (accounting purposes), ensuring we can assist you in resolving your inquiries or issues. 

14. Your personal data (usually contact and payment details) will be processed in accordance with our Privacy Policy. 

• Information is shared through: 
• e-mail communication, 
• share-drive provided by Microsoft Corporation,
• any other online-drive for sharing information requested by client. 

 15. Data transfer in case of termination of a provided service: 

• When we acknowledge the termination of our mutual cooperation, we have 10 working days to provide you with all data relevant for our cooperation. 

 16. Warranty and limitation  

• All products and services offered via our on-line shop are in line with European Union Pharmacovigilance law and guidances such as Good Pharmacovigilance Practices: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp.
• As part of using our products and, in particular, our services, we fully rely on the information provided by you to ensure that the service we deliver complies fully with applicable regulations. However, you agree that we accept no responsibility for the accuracy of the information you provide to us. We are not liable for your way of utilization of the product/service we have provided/have been providing to you. You further agree that we are not liable to you for any of the following losses you may incur, whether direct or indirect, and whether foreseeable or not: loss of profit, revenue, opportunity, customers, business, contracts, expectations, or reputation, as well as your liability to third parties. 
• If our cooperation—product or service—becomes the subject of inspections or other reviews by authorities or third parties, we commit to providing you with maximum possible assistance in delivering information regarding our cooperation, including direct communication with the authorities or third parties. Our assistance is subject to your explicit written request (sent by e-mail to compliance@qmfocus.com) and we will follow your instructions on the extent/scope of information regarding our cooperation that can/should be shared with the third party. We will only comment on the products/services we have delivered to you. We are not responsible for any additional processes or product modifications carried out with the products/services after their delivery. 
• We're not liable for any delays or failures in delivering the products caused by events beyond our control (commonly known as force majeure). These events include (but aren't limited to): internet issues or problems with products during online transmission, downtime or disruptions affecting computer systems, servers, payment services, or internet/telecom services used for payments or delivering products; power outages; strikes; civil unrest; natural disasters like fires, floods, storms, or earthquakes; terrorism; war; government actions; or any other event outside our reasonable control. 
• Our liability for possible damages including financial impacts caused to you in connection with the provision of services or delivery of products is always limited to the total value of the respective order. Respective order for repeated services (e.g. Local Literature Monitoring) means the order of the one particular month service.

 17. How Is Ownership Defined? 

• You understand and agree that all intellectual property rights to the products or parts of products labelled  as template/guidance or training are, and will always remain, entirely ours, or they belong to a third party clearly identified in the products description; this may happen when the product or service is delivered with cooperation with the third party. 
• Ownership rights are transferred to the client at the moment of delivery of the products/services. We are not responsible for any further handling of the products/services. 

 18. How to complain about a service/product? 

• You must notify us within 7 business days from delivery of the products/service if you find the products/service do not conform to the description of the product/service published on Vigidirect.com or to previously agreed e-mail communication. 
• You can send an e-mail on the e-mail address: compliance@qmfocus.com.  
• If you notify us within the above specified period, you agree to give us a fair chance—at least calendar 30 days—to fix the issues before you may decide to reject the products or terminate the contract.
• Although we will do our best to resolve the situation, in exceptional cases, we may conclude that it is not feasible or that we are unable to resolve it. In such a case, we will refund your payment for the service in question, reduced by our costs incurred in attempting to resolve the situation. If we are unable to resolve your complaint to your satisfaction, disputes may also be settled out of court in the Czech republic.  

 19. Is QMFocus, s.r.o. part of your PV system? Do you need to include QMFocus, s.r.o. in your PSMF? 

• You can always inquire whether the use of certain services and products meets the conditions for outsourcing PV activities. Generally, if our services have a direct impact on your PV system, it is considered outsourcing, and you should include these services in the description of your PV system, including in the PSMF. Each product description indicates whether there is an increased likelihood that the services and products will be part of the PV system. 

20. Other terms 

• The sale contract (including any non-contractual matters and obligations arising from or related to it) shall be governed by and interpreted in accordance with the laws of the Czech Republic. Any disputes, controversies, proceedings, or claims between the parties related to the sale contract (including any non-contractual matters and obligations arising from or related to it) shall fall under the exclusive jurisdiction of the courts of the Czech Republic. However, we reserve the right to bring a claim against you, enforce the sale contract and our intellectual property rights, or recover any amounts owed under the sale contract, in any jurisdiction where you reside, are domiciled, established, or have an office or place of business. 
• The validity of these terms is effective from January 1, 2025. 

 

Privacy policy

1. Personal Data Controller: 

• QMFocus, s.r.o. 
• Registered office: Slanska 195, Velvary, Czech Republic 
• Contact: +420 602 690 617, info@qmfocus.com 

2. What kind of personal data do we process? 

• We process only the necessary contact and identification data of our contractual partners (supplier, client): the first name and surname of the representatives (typically managing director, contact person), their email address, and phone number. The data is primarily processed electronically but may also include paper records or verbal communication. 

3. How do we get your data? 

• We have two types of data:  
  1. First, the information you give us, e.g., by phone or using e-mail, WhatsApp or filling in forms on our web-site/on-line shop. 
  2. Second, the digital data we collect about you. Everytime you visit our website/online shop, we may automatically collect certain pieces of information, depending on cookies you accept. Please read our Cookies Policy to learn more. 
• We may also collect phone numbers used to reach to our customer service number. 

 4. Why do we need the data? 

• This data serves to identify the contracting party and maintain essential operational contact. The legal basis for processing such data is the necessity to fulfill the contract or to take steps prior to entering into a contract. Providing this personal data by the contractual partner is a contractual requirement, and without it, the contractual relationship cannot be established. 
• We use this personal data for purposes other than those mentioned above (e.g., for subsequent marketing) only with the consent of the given contractual partner. 

 5. For how long? 

• We process the personal data of our contractual partners for the duration of the contractual relationship and subsequently retain it for additional 10 years, considering the statute of limitation in the event of legal disputes. Should a legal dispute arise, the data is retained for the entire duration of the proceedings. This archiving is based on our legitimate interests. Tax and accounting documents are archived for 10 years in compliance with legal obligations. 

 6. Do we share the data? 

• Personal data is managed internally within our company and is not provided to third parties. In exceptional cases where such disclosure is necessary, it is subject to the consent of the data subject. 
• In certain cases, we are authorized or obligated to disclose the personal data of contractual partners to public authorities as required by law. 

7. Do we keep the data safe? 

• Certainly! The personal data of contractual partners, both within QMF and our external accounting provider, is processed in compliance with strict security requirements. This includes storage exclusively on encrypted disks, strictly limited access rights, and rigorous physical security for non-electronic documents. 

 

 Rights of Data Subjects (DS) Regarding Their Personal Data 

 1. Right of access to personal data: 

• The DS has the right to know which of their personal data is being processed, for what purpose, for how long, where it was obtained, and whether and to whom it has been disclosed. They also have the right to be informed of their other rights concerning this data. This document is intended to provide such information, but we are also ready to confirm or clarify any of these points or provide the DS with a copy of the data we process. 

 2. Right to rectification of personal data: 

• The DS has the right to request the completion or correction of their personal data if they find it inaccurate or incomplete. 

 3. Right to restrict the processing of personal data: 

• In certain cases, the DS may request that some of their personal data be marked and excluded from further processing for a specific period. This differs from the right to erasure in that the restriction is not permanent. When processing is restricted, the data can only be processed with the DS’s consent, or for the purposes of establishing, exercising, or defending legal claims, protecting the rights of another person (either physical or legal), or for reasons of significant public interest. 

4. Right to object to the processing of personal data: 

• The DS can exercise this right by email at compliance@qmfocus.com.

5. Right to file a complaint with the Office for Personal Data Protection (www.uoou.cz): 

• The DS has the right to file a complaint if they believe their personal data rights have been violated. 

6. Right to erasure: 

• In certain circumstances, the DS has the right to have their personal data erased. We generally proceed with data erasure when there is no longer a legal basis for processing the data or when the data was processed based on consent, and that consent has been withdrawn. This right does not apply if the processing of personal data is still necessary for the fulfillment of our legal obligations, archiving purposes, scientific or historical research, statistical purposes, or for the establishment, exercise, or defence of our legal claims or performance of the contract. 

7. Right to data portability: 

• The DS has the right to request the transfer of their personal data to another data controller. 

8. Right to withdraw consent for further data processing: 

• The DS may withdraw their consent to further processing of their data at any time. 

 

Cookies Policy 

Introduction 

• Our website uses cookies to enhance your browsing experience, provide essential functionalities, and analyse website performance. This Cookies Policy explains what cookies are, how we use them, and your choices regarding their use. 
• By continuing to browse our website, you agree to the use of cookies as described in this policy. 

What Are Cookies? 

• Cookies are small text files stored on your device by your web browser when you visit a website. They allow websites to remember your preferences, gather statistical data, and improve functionality. 

How We Use Cookies 

• We use cookies for the following purposes: 

Essential Cookies 

• These cookies are necessary for the operation of our website, particularly for ensuring a smooth user experience on Shoptet.cz, which powers our e-commerce platform. 

Analytical and Performance Cookies 
We use Google Analytics to collect anonymous information about how visitors interact with our website. This data helps us improve the website’s functionality and ensure it meets the needs of our users. The information collected includes: 

1. Pages visited 
2. Time spent on each page 
3. Referral sources 
4. Device and browser information 

Functional Cookies 

• These cookies remember your preferences, such as language settings or previously added items in your shopping cart, to enhance your user experience. 

Marketing Cookies 

• These cookies may be used to deliver personalized advertisements based on your browsing history and preferences. 

Third-Party Cookies 

• Our website integrates tools and services provided by third parties, which may place cookies on your device. These include: 
  • Shoptet.cz: Essential and functional cookies for e-commerce functionality. 
  • Google Analytics: Analytical cookies for tracking user behavior and website performance. 

Managing Your Cookie Preferences 

• You have the right to control and manage cookies. You can: 
  • Adjust your browser settings to block or delete cookies. 
  • Opt-out of Google Analytics tracking by installing the Google Analytics Opt-out Browser Add-on. 
• Please note that disabling certain cookies may affect the functionality of our website. 

Changes to This Cookies Policy 

• We may update this policy from time to time to reflect changes in legal requirements or our use of cookies. Any updates will be posted on this page. 

Contact Us 

• If you have any questions about our use of cookies, please contact us at: 
  • QMFocus, s.r.o. 
  • Email: compliance@qmfocus.com 
• This policy is designed to comply with relevant privacy regulations, such as the General Data Protection Regulation (GDPR) and ePrivacy Directive, and ensures transparency about your use of cookies. 

Data automatically collected about you: 

• technical information, including the used IP address, your login information, browser type and version, time zone setting, browser plug-in types and versions, operating system and platform. We may also collect information about your visit, including the full Uniform Resource Locators (URL) clickstream to, through and from our site including date and time; items you viewed or searched for; page response times, download errors, length of visits to certain pages, page interaction information, and methods used to browse away from the page.  

Here are the cookies we use: 

• Strictly necessary cookies. These are cookies that are required for the operation of our website. They include, for example, cookies that enable you to log into secure areas of our website. 
• Analytical/performance cookies. These allow us to recognize and count the number of visitors and to see how visitors move around our website when they are using it. This helps us to improve the way our website works, for example, by ensuring that users are finding what they are looking for easily. 
• Functionality cookies. These are used to recognize you when you return to our website. This enables us to personalize our content for you, greet you by name and remember your preferences (for example, your choice of language or region). 
• Targeting cookies. These cookies record your visit to our website, the pages you have visited and the links you have followed. We will use this information to make our website and any advertising displayed on it more relevant to your interests. We may also share this information with third parties for this purpose. 

How do we use all the data? 

• to administer our site and for internal operations, including troubleshooting, data analysis, testing, research, statistical and survey purposes; 
• to improve our site to ensure that content is presented in the most effective manner for you and for your computer; 
• to allow you to participate in interactive features of our service, when you choose to do so; 
• as part of our efforts to keep our site safe and secure; 
• to measure or understand the effectiveness of advertising we serve to you and others, and to deliver relevant advertising to you; 
• to make suggestions and recommendations to you and other users of our site about goods or services that may interest you or them. Information we receive from other sources. We may combine this information with information you give to us and information we collect about you. We may use this information and the combined information for the purposes set out above (depending on the types of information we receive).