The Montrium platform FAQ
Your one-stop-shop for the most helpful and up-to-date ClinOps content written by our experts
on the front lines of the life sciences industry.
Your one-stop-shop for the most helpful and up-to-date ClinOps content written by our experts
on the front lines of the life sciences industry.
Yes, Montrium is happy to accommodate audits virtually via web conference or through postal audit questionnaires. Please send all requests to sales@montrium.com
Montrium has a built-in auditing feature to capture audit trails for records (documents) in our Records Center. The feature provides an audit log that records events, such as when content is created, viewed, modified, and deleted and includes the username of the user who performed the associated action along with the time and date when the event occurred.
Montrium ensures that platform releases are appropriately verified (tested), as part of the governing System Change Control process, before being deployed for use. Additionally, our team qualifies the underlying platforms and infrastructure and runs provided UAT test scripts as an additional measure. As a regulated user, Montrium subscribers are responsible for defining their intended use of the product and managing validation evidence.
Our implementation methodology has been designed to allow scaling teams to implement our products quickly and compliantly. Through a tried and tested process, that leverages the most up to date regulatory guidance our implementation process takes 30 to 60 days from kick-off to go-live.
For every new customer we partner with we assign a committed and dedicated team to ensure the success of the implementation and overall customer experience. Your customer team consists of a dedicated Product Specialist who will guide you through your implementation project. An account manager, who is responsible for ensuring business success and your technical support team.
Montrium provides a comprehensive set of documentation alongside the implementation of any of our products. These documents are designed to accelerate the execution of the validation and governance phase of your implementation project.
The following is what is provided to all customers at no additional cost:
In an effort to streamline and accelerate our implementation projects, Montrium has engineered a best-of-breed validation strategy leveraging a risk-based validation approach. This approach allows customers to leverage the extensive testing, qualification, and validation efforts Montrium’s team has performed to significantly reduce the testing required on the customer-side.
Montrium also supports a more traditional approach to validation where customer team can carry out User Acceptance Testing leveraging the full documentation package provided by Montrium. Learn more about our validation support here.
Montrium’s implementation process has been designed to accelerate the implementation and use of our products. A key part of this accelerated process is the provision of templates for standard operating procedures. All implementation projects are accompanied by a comprehensive set of procedural templates that cover:
Documentation provided varies depending on the implementation project.
Training is one of the most crucial milestones in any implementation project. Montrium’s Product Implementation Teams see training as a partnership between the customer and our team. Training is comprehensive and is often customized to our customers specific use case, removing the need for redundant training activity. We take a multi-faceted approach to training your teams, combining classroom-based training with in-system exercises creating the perfect balance between practical hands-on learning and theoretical exploration. As always, customer teams that dive headfirst into training enthusiastically and work hard to evangelize the platform and the training material often have a shorter learning curve and increase user adoption earlier. Montrium provides a range of training activities to ensure the different types of users receive the material and support they need to carry out their tasks. As part of the onboarding process, Montrium provides Application Manager, Super User and End User training. For each module that our customers onboard, the product implementation team provides a bank of training hours based on the application and subscription you select.
All users have unlimited and unrestricted access to carefully crafted learning content within Montrium’s Help Center. The Help Center is accessible from directly within each module and includes a wealth of articles, videos and other help content to ensure users have the knowledge they need to complete their workload.
Montrium’s products are designed with the end-user in mind and as such requires minimal training to become proficient in day-to-day activities. Through the combination of comprehensive training support during implementation, on-demand training content in our Help Center and 24/7 technical support, users are well supported in their use of the Montrium platform.
Customer support is provided at no additional cost and is available 24/7 for priority issues. Standard support is available during normal business hours, Monday through Friday:
Customer support is provided at no additional cost and is available 24/7 for priority issues.
Yes, all technical support is provided by a localized internal support team.
All products provided by Montrium feature robust and configurable access control and permission management functionality. Whether through directly assigning permissions for a user or configuring access for a user group, customers have complete control over the access their internal and external users have.
Yes, Connect supports both internal and external users within the platform.
Yes, Connect applications can be connected to your in-house identity provider using our SSO integration capabilities.
For North American subscribers, production services are based in Virginia (East US & East US2) and backups and redundant services are in California (West US).
For European subscribers, production services are based in the Netherlands (West Europe) and backups and redundant services are in Ireland (North Europe).
For Connect Data, each Subscriber is provisioned databases unique to them which are encrypted at rest with an encryption key unique to the Subscriber. The Subscriber’s Application Manager is responsible for assigning their end user’s user account to the different user's groups (permission groups) according to their job titles/responsibilities.
Yes, all employees are bound by confidentiality.
Yes, all failed logins are tracked in a secure audit history accessible by authorized individuals only.
The Connect platform is entirely web-based and accessible through any modern and updated browser application.
Connect applications are hosted natively on the Microsoft Azure cloud service
Yes, Connect is a modern, fully-managed Software-as-a-Service product delivered directly through your browser.
Connect has been engineered from the ground up with functionality to ensure compliance with technical controls described within FDA 21 CFR Part 11 and other applicable regulations. Subscribers (regulated users) remain responsible for implementing their own procedural controls allowing them to achieve compliance with FDA 21 CFR Part 11 and any other regulations they are subject to.
Yes. Connect is a multi-modular SaaS platform, giving customers the freedom to select the applications that meet their needs today and onboarding new products as needs grow.
Montrium prepares the Connect solution for Subscribers by incorporating their operational parameters during the on-boarding process. Following this process, the Connect applications and modules are defined as Category 3 (Non configurable software) as they are pre-configured (as is). The infrastructure that supports the Connect platform is defined as Category 1 (Infrastructure software).
Montrium’s pricing model is designed to be simple and cost-effective for organizations of all sizes. Our pricing is typically split into three core fees: technical set-up and onboarding fees (one-time), document and data migration fees, and monthly subscription fees. Subscription fees are based on named users with no limits to number of documents, products, projects, studies, or sites.
Yes, Montrium’s quality management system is defined by its Quality Manual and is designed to provide assurance that the services and products provided by Montrium are provided in accordance with quality management principles, good practices and applicable regulations.
Montrium’s Connect platform consists of a series of business-critical applications delivered in a cloud-native SaaS model. We leverage geo-replicated data centers within the Microsoft Azure cloud and utilize a series of Microsoft and Montrium components to deliver a best-in-class cloud platform.
The Montrium platform leverages Adobe Acrobat Sign to apply compliant electronic signatures. Electronic signature requests are initiated within Connect and are transmitted to Adobe’s electronic signature service by leveraging Adobe’s available REST APIs; access-control ensuring signer authenticity, data integrity, and non-repudiation of documents is managed through Security Assertion Markup Language (SAML).
Subscriptions are typically based on the number of user licenses required to access the system monthly. Subscription terms are available in 12, 24 and 36 month terms.
You won’t need to install any software to run your Connect application. All of our applications are accessible from most devices from any modern web browser.
The Connect applications have been developed to be browser and device agnostic, responsively designed and always secure.
The Connect platform is designed to help growing companies take their first step into managing their regulated content digitally for the first time, but built with scalability in mind so you have lots of room to grow in the future.
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