Annex 4: User Requirements

  1. General Requirements

# / Requirement / Rating / Service Provider Feedback
The system must:
1.1 / Be readily accessible from all sites defined in the scope of work. / MAND
1.2 / Be readily accessible via the Company intranet. / NTH
1.3 / Be available worldwide on a 24/7 basis. / MAND
1.4 / Provide an interface in English. / MAND
1.5 / Provide interfaces in other languages. / NTH
1.6 / Allow an undefined number of concurrent users at the same time. / MAND
1.7 / Have fast login and processing (e.g. no more than 5 seconds). / MAND
1.8 / Have fast and easy access to documents (e.g. no more than 10 seconds). / MAND
1.9 / Support the concurrent access to a same document without affecting the speed of the system. / IMP
1.10 / Be intuitive and simple use. / MAND
1.11 / Provide online help for the application. / MAND
1.12 / Provide meaningful error messages, so that they can be appropriately acted upon by the users. Error messages should provide help for solutions. / IMP
1.13 / Have a user guide/manual for off-the-shelf system. / MAND
1.14 / Have available support 24/7. / IMP
1.15 / Clearly identify the environment of connection (e.g. production, training, validation) at any time. / IMP
1.16 / Display “processing” during processing step to show user that the system is working. / NTH
  1. IT Functionalities & Part 11 Compliance

# / Requirement / Rating / Service Provider Feedback
The system must:
2.1 / Comply with FDA 21 CRF part 11 regulations. / MAND
2.2 / Have a data centre that complies with ISO 27001 / MAND
2.3 / Have up-to-date documentation of system validation + 21 CRF Part 11 compliance. To be made available upon DNDi’s request. / MAND
2.4 / Create an audit trail indicating at least User ID, Record ID, Date/Time, what action and the reason for the change. / MAND
2.5 / Maintain the audit trail for as long as the life of the document to which it refers. / MAND
2.6 / Maintain the integrity of the audit trail. / MAND
2.7 / Maintain integrity of the documents at all times regardless of maintenance activities, other user actions, failure of system components. / MAND
2.8 / Save a draft in case of system crash or user timed out of system. / MAND
2.9 / Ensure automated backup and recovery procedures. Full integrity of the data must be maintained after the restore and through generations of application software. / MAND
2.10 / Prevent the deletion of an electronic document or any part of its content at all time with the only exceptions of destruction in accordance with a retention schedule. / MAND
2.11 / Restrict document destruction permissions to limited persons and require a “reason” for destruction. / MAND
2.12 / Prevent unauthorized individuals to alter data/records. / MAND
2.13 / Have electronic signature of documents by User ID and password. / MAND
2.14 / Capture the meaning of an electronic signature at the time of signing (e.g. approval of a document). / MAND
2.15 / Be accessible via a smartphone or tablet. / IMP
2.16 / Be available off-line. / IMP
2.17 / Provide a light-weight version of the standard interface for sites with limited bandwidth. / IMP
2.18 / Integrate or be able to interface with Company e-mail system (Outlook) in order to allow users to send records/files electronically. / IMP
2.19 / Be able to interface with other systems (e.g. Sharepoint on premises, Salesforce.com etc). / IMP
2.20 / Allow administrators to configure new, or edit existing lifecycles and workflows. / IMP
  1. Access Control & Security

# / Requirement / Rating / Service Provider Feedback
The system must:
3.1 / Be able to manage different levels of access rights. / MAND
3.2 / Prevent the creation of a new user ID if the user ID is already in use. / MAND
3.3 / Allow access by User ID and password which must be unique and cannot be re-used or re-assigned to another user. / MAND
3.4 / Allow access via single sign-on (Microsoft Azure AD). / IMP
3.5 / Synchronize and authenticate with Active Directory or other identity providers. / IMP
3.6 / Lock out users after a certain number of unsuccessful logon attempts (to be determined at system installation). / MAND
3.7 / Assign key people for the administration of the system (Administrators). / MAND
3.8 / Assign different levels of administrators (Global and Local). / NTH
3.9 / Allow administrators to create/disable users in the system. / MAND
3.10 / Allow administrator/local administrator to unlock and manage rights for users. / MAND
3.11 / Allow access to archived/obsolete documents by local administrator. / MAND
3.12 / Time out after a defined period of inactivity within the system (to be determined at system installation). / MAND
3.13 / Allow administrators to manage the inactivity timeframe. / NTH
3.14 / Show the full name of the person accessing the computerized system, throughout the application and at all times during his/her connection. / MAND
3.15 / Restrict access to system functions according to user’s role. / MAND
3.16 / Allow a user to be a member of more than one group/clinical trial. / MAND
3.17 / Allow a user to have different roles/accesses per clinical trial. / MAND
3.18 / Ask for renewal of the password after a predefined period (if the system is not compatible with SSO). / MAND
3.19 / Inform user of password expiry minimum 2 weeks in advance (if the system is not compatible with SSO). / MAND
  1. Folder requirements (creation, content, metadata)

# / Requirement / Rating / Service Provider Feedback
The system must:
4.1 / Provide a pre-defined folder structure with leeway for minor modifications. / MAND
4.2 / Allow customization of folder nomenclature. / MAND
4.3 / Allow customization depending on national/regional requirements at a site or country level. / MAND
4.4 / Allow administrators (potentially users) to create new folders within a given trial. / MAND
  1. Document requirements (creation, content, metadata)

# / Requirement / Rating / Service Provider Feedback
The system must:
5.1 / Be able to import and handle multiple document types (e.g. Word, Excel, PowerPoint, Gantt charts, pdf, jpeg, png, jif, outlook e-mails). / MAND
5.2 / Be able to store a document in its native form (e.g. Word, pdf etc) including all standard fonts. / MAND
5.3 / Manage records in multiple languages and handle different characters. / MAND
5.4 / Allow the possibility of bulk upload (multiple documents at same time). / NTH
5.5 / Detect and notify of duplicate documents in the system during import. / MAND
5.6 / Ask for defining a minimum number of attributes/meta-data when creating/importing a document. / MAND
5.7 / Allow meta-data elements to be managed by Administrators. / MAND
5.8 / Allow the possibility to define a list of mandatory documents at a study, country and site level. / IMP
5.9 / Provide a unique ID for each document. / MAND
5.10 / Store a large number of documents (e.g approx. 10’000 docs per trial). / MAND
5.11 / Be able to handle big size documents (e.g. Clinical Reports of approx. 100 pages + appendices of >1’000 pages, 25-50’000 KB). / MAND
5.12 / Allow users to create cross-references (e.g. links) between related files. / MAND
5.13 / Allow users to cross-reference documents across trials (e.g. for Investigator Brochures used for several trials). / MAND
5.14 / Assign a status to an uploaded document (e.g. Uploaded, Verified, Superseded, Archived) / MAND
5.15 / Assign a status to a document created in the system (e.g. Draft, Approved, Superseded, Obsolete, Archived). / MAND
5.16 / Allow attribution of versioning to certain uploaded documents. To be selected as optional meta-data. / MAND
5.17 / Allow attribution of minor and major versioning to documents created in the system. / MAND
5.18 / Be able to generate and manage templates. / NTH
  1. Printing and Downloading

# / Requirement / Rating / Service Provider Feedback
The system must:
6.1 / Ensure accuracy of printed documents with electronic records. / MAND
6.2 / Allow downloadable format of certain documents. / MAND
6.3 / Allow the possibility to export certain documents. / MAND
  1. Searches and Reports

# / Requirement / Rating / Service Provider Feedback
The system must:
7.1 / Be capable of full text, field and meta-data searches. / MAND
7.2 / Be capable of searching by several meta-data. / MAND
7.3 / Include all records/documents (including those the user does not have access to) in the search results. / NTH
7.4 / Allow creation of global or personalized search lists. / MAND
7.5 / Permit extraction of lists in printable/saveable format. / IMP
7.6 / Provide reporting tools for the provision of statistics to users. / IMP
7.7 / Permit extraction of reports in printable/saveable format. / IMP
7.8 / Be capable of running reports on empty folders (e.g. indicate that folders contain no documents). / IMP
7.9 / Be capable of providing real time reporting (e.g. at least 12 hours). / MAND
  1. Additional questions

8.1 / What are your Recovery Point and Recovery Time objectives?
8.2 / What is your Uptime & Service Level Agreement?
8.3 / What is your Licensing module? (e.g. Per site, per user, per concurrent user ?)
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