Q: Does your platform have a CAPA module?

A: Yes, the MBL platform consists of 16 modules including CAPA.

Q: Are there templates for each Module?

A: Each of MyBlueLabel’s modules works as a template to give your business an advantage. MyBlueLabel gives you the possibility to work with MyBlueLabel’s predefined templates, your own templates, or a combination.

MyBlueLabel document templates are a part of the Procedure that can be purchased for each Module. The Project Management Module comes with a set of templates for Computerized System Validation depending on your type of project.

A: Can we have a customized module?

B: If your company needs Customized Add-on modules, we can develop them with you, as long as there is a synergy with the Quality Management processes.

Q: Is it possible to access the MyBlueLabel solution from a mobile device?

A: Yes, it is possible to access the MBL solution on multiple devices (Tablet, phone, computer)

Q: Where is the server (information storage)?

A: Microsoft Azure Servers Located in the western part of Europe (The Netherlands) for normal storage and backup routine (EU jurisdiction), 

with a paired server in North Europe (Ireland)for disaster recovery setup.

Q: Who owns the data (put on the platform / into the solution)?

A: All rights to the data within the platform belong to You (the company). MyBlueLabel does not own any customer data.

Q: What if MyBlueLabel goes bankrupt or similar? What happens to the platform and our data? 

A: The solution is stored on Microsoft Azure Servers, and should it happen that MyBlueLabel is for some reason no longer able to provide services, then the data and login will always be possible as usual. There will not be any updates and maintenance on the current version of the built software. Furthermore, the data can be easily exported and stored locally.

Q: Do you have a support hotline?

A: Yes, our toll-free support hotline is open Monday-Friday from 08:00-17:00

Q: What is the uptime of the server?

A: 99.9% – (Microsoft Azure SLA service uptime) 

Q: Can my company grow or scale with the MyBlueLabel eQMS?

A: Yes, MyBlueLabel provides pre-market and post-market modules covering a full product life cycle. The standard platform is licensed per number of Users. The number of Users can increase over time, as the company grows. 

Q: Is the MyBlueLabel platform only capable of handling ISO 13485?

A: MyBlueLabel supports several international standards, among others ISO 9001 (General Quality Management System), ISO 13485 (Medical Devices), ISO 14001 (Environment), ISO 27001 (IT Security)

Q: Is MBL only for the European market?

A: The platform is EU, FDA, and UKCA-compliant and we have the ability to help your company gain market access in any target market you might have.

Q: What is the maximum storage?

A: By default the license covers 200 GB storage. This size can be increased if applicable. To set this into perspective, 2,000 unique records (Word, excel, PDF) with multiple file versions will take up approximately 10 GB of data. Building a Quality Management System from scratch and also using the solution for good business practices will take 5 years under normal conditions to procedure 2,000 records. (A QMS system is 50 procedures and forms, and a technical file may have 100 unique documents excluding attachments)

Q: How is the license paid? 

A: The license is paid yearly upfront. 

Q: Do you need the MBL templates to use the platform?

A: MyBlueLabel is flexible enough so you can use your own documents. At MyBlueLabel we typically migrate, train, etc., so clients are fully running within 2-3 weeks.

Q: Is there a demo environment? Freemium?

A: We allowed earlier a freemium solution but learned that companies did not use it if there was no commitment. Therefore MyBlueLabel offers a 3-month money-back guarantee. You can book a demo with one of our Sales Representatives any time – and within reason – as many as you want to ensure that You feel full security before choosing MyBlueLabel.

Q: Is it possible to grant access to stakeholders outside of the company?

A: Yes, you can grant access and permission to anyone. 

Q: How does MBL keep its software compliant in an ever-changing regulated environment 

A: MBL is getting re-certified every 4 years with follow-up audits every year. MyBlueLabel has been audited successfully 5 times.

Q: How does MyBlueLabel deal with local regulations?

A: MyBlueLabel makes sense of regulations. By default, we have adopted all the global regulations. If there are any local regulations that are specific to certain countries, we can enhance the MyBlueLabel standard procedures to include the local requirements as well. This will come with an add-on to the standard prices.

Q: Are MyBlueLabel helping companies outside of Europe and helping European companies access international market opportunities? 
A:  MyBlueLabel supports both European and companies that are not European, by meeting EU rules and regulations, and in this way, the companies will be able to sell products in the European Market. Likewise, if a company from Europe, or any other place in the world, wants to access the US market, then we help the companies understand the US rules and regulations so that they will have approved products and services.

Q: Is it possible to integrate other platforms/solutions (e.g. Jira, ERP)?

A: Yes, there is no limit to the number of integrations. However, integrations will be viewed as independent projects. 

Q: What certifications does the platform have?

A: Here is a list with all our certifications and compliance standards

ISO 9001:2015 (certified)

EU GDPR compliant

ISO 27001 compliant

ISO 14001 compliant

In addition, the application is hosted on Microsoft Azure which has the following certifications. To name a few:

ISO 27001

ISO 9001

GxP (FDA 21 CFR Part 11)

EU GDPR

Features that ensure fast and intelligent compliance:

• Electronic Signature (US Part 11 / EU Annex11)

• Business Intelligence Dashboards

• API External Integration

SYSTEM VALIDATION & CERTIFICATIONS

• ISO 9001: 2015

• GAMP5 – A Risk-Based Approach to Compliant GxP Computerized Systems

• FDA 21 CFR Part 11

• EudraLex Annex 11

Q: Are your solution pre-validated?

A: Yes, the MBL platform is pre-validated. This means that you do not need to validate the solution yourself. This rationale must be documented in your procedures. When we deliver the solution, we also deliver an example on a supplier evaluation including:

– Supplier Evaluation Questionnaire

– ISO certificate (ISO 9001)

–  Validation Report (GAMP 5)

These documents are usually satisfactory to satisfy external auditors. In some rare cases, we also send the Backup and Restore Procedure to close out any questions. 

Delivering the solution pre-validated can save you months on the implementation time.

Q: Typical implementation time?

A1: When starting for nothing we typically implement a full QMS within 5 days. Read more

A2: When digitalizing data it depends on the amount of data and scenario. However, the average onboarding time is approx. 20-30 days.

Q: Can I migrate my current data into the system?

A: Yes, all previous data generated and collected can be migrated into the platform.

Q: Typical implementation time?

A1: When starting from nothing we typically implement a full QMS within 5 days. Read more.

A2: When digitalizing data it depends on the amount of data and scenario. However, the average onboarding time is approx. 20-30 days. 

Q: Who normally is trained in our organization/company?

A: Typically we train the Quality Responsible. Quality Responsible then is responsible for training the rest of the company organization. This can vary a bit from organization to organization.

Q: How does the training of our employees take place?

A: At MyBlueLabel we do both online and training on-site. The trend is more and more trainings take place online

Q: Who participates in the MyBlueLabel establishment or migration phase?

A: Normally one of our implementation specialists. Are you a large company with numerous people to be trained, we 5ight have two or more specialists present from MyBlueLabel to ensure thorough training.

Q: How long is the duration of training?

A: On average our clients are fully trained within 5 working days spending no more than 20 hours internally in the organization.

Q: How long is the duration of migration?

A: On average our clients are fully migrated in 3-4 weeks. (DATA)

Q: What is the typical duration of all processes before we are fully running in the MBL digital platform/solution?

A: On average our clients are fully running within XXXXXX days.

Q: You say it takes 5 days but how much time is needed for internal resources(time /money) to implement the MyBlueLabel eQMS system?

A: You have to spend 5 days in the workshop with us – 20 hours in total. Then you need to train the rest of your staff. If a migration of data is needed (see timeline in the migration question), then a data migration plan must be approved, the data must be validated to be true and accurate, and then a data migration report must be signed off. Between 5 and 30 days would be the standard onboarding process to be expected allocated for 1-2 internal resources.

Q: How do we know what you say is correct?

A: MyBlueLabel is being certified by DNV and follows a yearly audit cycle.

Further, the procedures and templates are being reviewed yearly by collaboration partners (approximately 30 consultants with a minimum of 10 years of experience). In addition to this, companies (Clients/customers) using our templates have successfully passed audits from, for instance, BSI, TUV SUD, and DEKRA.

Q: How do I get started?

A: You contact one of our sales representatives, who will help set up a demo of the solution.  When you are satisfied with what you see, we will give you a quote, which you will need to sign.  We do this already in our configured solution with your logo, so you can test our electronic signature feature, and avoid standing by the printer. Then the contract is signed, the MyBlueLabel implement team will set up the environment for you.  Within 5 days you will be a fully functional eQMS solution.  From there, it depends on the packages that you are interested in.  We recommend a 5-day workshop to keep momentum and get the documents signed off.  Then you are good to go.

Q: It sounds too good to be true

A: Yes, this is a problem of ours, that the perception of quality and pricing goes hand in hand. However, we have a mission to make compliance available and obtainable to all companies no matter what size. Therefore we have a very attractive pricing structure with a pay-as-you-grow mechanism. On the other hand, we believe that now with over 300+ customers, it cannot all be too good to be true.