Frequently Asked Questions

Is CIMS eSystems a standard set up or can it be customized?

A: The baseline system is very flexible for Client-specific configurations, however CIMS eSystems provides a standard set-up as a service to a Client in order to easily start using the system. Adaptation will be fitted the Client needs for example adding libraries according to Client naming and structure conventions, different flows, configurable trackers, templates, reports. We can perform customization of the system as per Client’s requirements.


What does the CIMS eSystems comply with?

A: CIMS eSystems is compliant with all major international and local regulations, such as:

  • ICH GCP E6 R2
  • EudraLex Volume 4 Annex 11
  • FDA 21 CFR Part 11
  • GDPR

CIMS eSystems is audit-ready: We are always ready to pass on-site or remote audits and fill in any assessment questionnaire from your quality assurance.


Where will be my Data Center?

A: 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 Denmark.

When you say level B is access controlled, what is meant by that? A: Only administrators have access i.e., operate within the system. The Client must determine who and how many will act as administrators. Remaining users can see everything, though, nut not operate. Also, level A content can be seen by all users, but only dedicated users can post and retrieve (copy only) documentation.


For how long time will documents and data be stored? And what information is stored?

A: Documents and data can be stored as long as the Client want. All documents will have a version history saved forever. Only the activity log has a storage limitation of 3 months.


Why is the activity log not stored for a longer time?

A: Microsoft decides the storage time for the activity log, however, as version history of a document is stored forever which is what is required by GCP.


Can you give examples of documents which are intended to be stored in level B but not in necessary in level A?

A: Company documents that are not part of the TMF can be stored in level B. Also, Client QMS documents not part of the TMF would be stored in level B.


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?

A: Yes, we provide a validation certificate. Th 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 CIMS eSystems.


Where and how will the data be stored in the data repository?

A: 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. CIMS eSystems offers servers based in Denmark. For the data repository, the normal SharePoint functionalities are removed, and the data repository can be seen as a file server.


How is a document signed off and which systems can be used with CIMS eSystems?

A: DocuSign is built into CIMS eSystems. However, other electronic signature systems such as Adobe can be used.


Which version of DocuSign is used? Does the signature specify the “reason for signing”?

A: Yes, the signature specifies the reason for signing. The DocuSign version is 21 part 11 compliant.


When a document is signed, will it automatically be moved into level B?

A: When signed, you have manually to move the document into level B. However, this can be made automated with a workflow if this is a wish for a Client.


Is it possible to add metadata, and if yes, how is this done?

A: 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?

A: Yes. Any TMF document can be added metadata to assign eCTD name for eCTD documents. This will be up to the Client to decide.


Will the Client have to provide access to the system themselves or will it be CIMS eSystems who provides access?

A: CIMS eSystems will provide access upon a request form for a “new user” is sent from Client.


What is the implementation time when a Company decides to us ethe system until the system is up running?

A: If the Company is ready and knows what they want i.e., user requirements, CIMS eSystems can have the system up running in less than a month.


What is the time from requesting access for a new user to the user can use the system?

A: Usually within 1 day.


Can access to specific folders be provided to a Client’s auditor?

A: Yes, that can be done with a notice time of 2 weeks.


How is system maintenance handled?

A: Any maintenance follows notification from Microsoft (MS) and the Client will be notified if this requires a down time of system. However, if SharePoint online or 365 is used, this will not happen often if SP 365 is used (online).


Is a help desk available?

A: Yes.


Is CIMS eSystems ISO certified?

A: No, not now, but this is planned for the near future. However CIMS eSystems' QMS is based on ISO 9001 and ISO 27001. 


Does the system also contain a learning management feature such as a learning management system build in?

A: A learning management system is not built in yet, but CIMS eSystems is working on this. We anticipate that it will take up to 6 months to develop and implement. So, yes, this can be included. However, as the system is now, a workflow (WF) can be created for a document that needs to be “trained in” and thus act as a pseudo learning management feature. This will be an easy task to incorporate.


Will SOPs be provided?

A: 5 SOPs are delivered when contracting with CIMS eSystems. They are provided as templates as this will enable the customize to the Clients quality management system.

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