Frequently Asked Questions
Your Questions, Answered - Novyra eSystems Explained
Setup and Implementation
Is Novyra eSystems a standard set up or can it be customized?
Novyra eSystems provides a standard set-up as a service to a Client in order to easily start using the system. However, the baseline system is very flexible for Client-specific configurations. Adaptation will be fitted the Client needs for example adding libraries according to Client naming and structure conventions, various flows, configurable trackers, templates, reports. We can perform customization of the system as per Client’s requirements.
What is the implementation time when a Company decides to use the system until the system is up running?
If the Company is ready and knows what they want i.e., user requirements, Novyra can have the system up running in less than a month, typically 2-4 weeks.
Is it possible to add additional metadata, and if yes, how is this done?
Yes, it is possible. The Client has to decide if his is done by the document creator, approver or other.
Is it possible to indicate which documents needs to be part of an eCTD?
Yes. Any essential records can be added metadata to assign eCTD name for eCTD documents. This will be up to the Client to decide.
Compliance and Validation
What does the Novyra eSystems comply with?
Novyra eSystems is compliant with all major international and local regulations, such as:
- ICH E6(R3) GCP
- EudraLex Volume 4 Annex 11
- FDA 21 CFR Part 11
- GDPR
Novyra eSystems is audit and inspection ready: We are always ready to pass on-site or remote audits and fill in any assessment questionnaire from your quality assurance.
For how long time will documents and data be stored? And what information is stored?
Documents and data can be stored as long as the Client want. All documents will have an unlimited version history and the system has an activity log.
What about validation? In case a client will use the system, they most likely want to audit. Can the client see everything that has been done?
Yes, we provide a validation certificate. The validation report and/or a summary of the validation done can be shared through an audit. What will not be shared with a client is the validation script as this is the intellectual property of Novyra.
Where will my Data Center be located?
We have a list of prequalified Data Centers according to our SOPs. Location of servers and backups are agreed and reflected in the Service Level Agreement. Exact Data Center location and type depends on the Client’s requirements.
Currently, we work with Data Centers in Europe.
Where and how will the data be stored in the data repository?
The data in the data repository will either be stored in a cloud-based service provided directly from Microsoft or a locally-hosted platform (server). If it is a wish, the Company can own and operate server themselves. Both the cloud-based service and the locally-hosted platform are placed within the European Union. Novyra eSystems offers servers based in Europe.
Will system SOPs be provided?
Five SOPs are delivered when contracting with Novyra eSystems. They are provided as templates as this will enable the customize to the Clients quality management system.
Is Novyra eSystems ISO certified?
eSignatures
How is a document signed off and which systems can be used with Novyra eSystems?
DocuSign can be built into Novyra eSystems. However, other electronic signature systems such as Adobe Sign can be used as well.
Which version of DocuSign is used?
Any version of DocuSign can be used. The DocuSign version can be 21 part 11 compliant and include a reason for signing.
Access Control
Will the Client have to provide access to the system themselves or will it be Novyra eSystems who provides access?
Novyra eSystems will be responsible for access management and provide access upon a request form for a “new user” is sent from Client.
What is the time from requesting access for a new user to the user can use the system?
Usually within 1 day.
Can access to specific folders be provided to a Client’s auditor?
Yes, that can be done with a notice time of 2 weeks.
General
How is system maintenance handled?
Any maintenance follows notification from Microsoft (MS) and the Client will be notified if this requires a down time of system. However, since Novyra eSystems use Microsoft 365, this will not happen often. Furthermore periodic revalidation is performed by Novyra.
Is a help desk available?
Yes, 24/7 call service is available for support.