We are in the process of evaluating Confluence Cloud - have several questions

[Conni Drejer]

We have a list of requirements and we tried to validate them all by testing. Allthough we have tested every single one of them we would really like you to to  choose Yes/No/Partial (maybe wiht a short note) to the topics in the list.

We hope you can find the time, so that we can take the stepå and choose Confluence/Comala Document Manager and Comala Publishing as our new QMS-system.

Functional Requirements

System Functions

This section provides documentation of the general requirements for the document management system. The requirements mentioned are functional requirements that enable the system to perform the current process.

URS-Con-0001
Criticality: Q
Description: The system must differentiate between multiple document types (e.g., procedures, instructions, and templates).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0002
Criticality: Q
Description: Draft, current, and obsolete versions of documents in the system must be accessible separately.
Rationale: It must not be possible to use documents that are in draft or obsolete status (GAMP5 2nd edition sections 17.3.4 and 17.3.7).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0003
Criticality: Q
Description: The system must be able to number documents uniquely and unambiguously.
Rationale: Documents must be uniquely identifiable (EU GMP 4.3).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0004
Criticality: Q
Description: The system must be able to version documents.
Rationale: Changes must allow for the retrieval of previous versions. Changes must be traceable (EU GMP 4.9 and GAMP5 2nd edition section 17.3.1).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0005
Criticality: Q
Description: Based on version or status in a workflow, it must be possible to see if a document is a draft, under approval, approved, or obsolete.
Rationale: It must not be possible to use documents that are in draft or obsolete status (GAMP5 2nd edition sections 17.3.4 and 17.3.7).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0006
Criticality: Q
Description: Once a document is in the approval process, it must not be editable or deletable; it should be locked in a non-editable format.
Rationale: It must not be possible to use documents that are in draft or obsolete status (GAMP5 2nd edition sections 17.3.4 and 17.3.7).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0007
Criticality: Q
Description: When all assigned approvers or reviewers have approved the document, it is automatically elevated to the current status.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0008
Criticality: Q
Description: The approval process for documents is automatically interrupted at the first rejection by an assigned person, and the document is given draft status.
Rationale: Documents must always have a status.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0009
Criticality: Q
Description: It must not be possible to send a document into the approval process without an assigned approver.
Rationale: Documents must not "hang" in the system.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0010
Criticality: Q
Description: It must not be possible to send a document into the approval process with fewer than two assigned approvers.
Rationale: Documents in the quality management system are subject to the "four-eyes principle."

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0011
Criticality: Q
Description: A draft of a document is first (and automatically) created when the document is elevated to current status.
Rationale: It must be ensured that there is always only one draft available.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0012
Criticality: Q
Description: The system must notify assigned persons in the review or approval process if the process is stopped.
Rationale: Documents must not "hang" in the system; there must always be an owner to ensure the document is carried forward.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0013
Criticality: C
Description: The system must support the workflow with author, reviewer, and approver roles.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0014
Criticality: Q
Description: Upon approval, the approver must sign with an electronic signature. The approval date must be displayed.
Rationale: EU GMP 4.3 and GAMP 5 2nd edition section 13.3.2.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0015
Criticality: Q
Description: It must be possible to send documents for review (not part of the approval process).
Rationale: Documents should primarily have an author and an approver for approval, but there may be cases where a formal or informal review by a specialist is needed.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0016
Criticality: Q
Description: It must be possible to access obsolete documents.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0017
Criticality: Q
Description: The system must have a search function.
Rationale: GAMP5 2nd edition section 17.3.4.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0018
Criticality: Q
Description: It must be possible to search by:

• Document title
• Number
• Keywords
  Rationale: GAMP5 2nd edition section 17.3.4.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0019
Criticality: C
Description: It must be possible to set review periods on documents.
Rationale: By setting deadlines on review periods, progress on document approval is ensured.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0020
Criticality: Q
Description: Workflow for review and approval of documents with configuration options to restrict approval authorization roles and permissions to specific users.
Rationale: Only authorized personnel may approve and date documents (EU GMP 4.3).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0021
Criticality: Q
Description: There must be traceability between procedures, instructions, and templates.
Rationale: It must be possible to identify which documents relate to each other.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0022
Criticality: Q
Description: The system must notify users that a task has been assigned (e.g., approval of a document).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0023
Criticality: Q
Description: It must not be possible to delete a QMS record (similar to tasks in JIRA).
Rationale: GAMP5 2nd edition section 17.3.7.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0024
Criticality: Q
Description: If there is a need to archive a document as obsolete, it must be justified.
Rationale: GAMP5 2nd edition section 17.3.7.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0025
Criticality: C
Description: It must be possible to filter by the status of documents, approver, author, type, etc.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0026
Criticality: Q
Description: Changes to approved documents can only be made by the same roles that initially created, reviewed, and approved the document.
Rationale: GAMP5 2nd edition section 17.3.5.`

Confluence/Comala Document Manager: Yes/No/Partial

Security Including Access Control

URS-Con-0027
Criticality: Q
Description: It must be possible for external users (not registered in RN AD) to access the solution, both for reading and writing.
Rationale: It must be possible for regional QA specialists, for example, to access the system.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0028
Criticality: Q
Description: The system must be able to manage user access and assign different access levels based on the user's role.
Rationale: Only authorized personnel may approve and date documents (EU GMP 4.3).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0029
Criticality: Q
Description: It must be possible to create a user who only has view access to see current documents, not drafts or obsolete ones.
Rationale: Only authorized personnel may approve and date documents (EU GMP 4.3).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0030
Criticality: Q
Description: It must be possible to define via permissions which roles have rights to view, update, and move documents.
Rationale: Only authorized personnel may approve and date documents (EU GMP 4.3).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0031
Criticality: Q
Description: Only persons assigned to a document in the approval process and admin can cancel the approval process for a document.
Rationale: Only authorized personnel may approve and date documents (EU GMP 4.3).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0032
Criticality: Q
Description: All users, including their roles and permissions, must be traceable in the system.
Rationale: Only authorized personnel may approve and date documents (EU GMP 4.3).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0033
Criticality: C
Description: The system must provide error codes if the user attempts actions that are not possible.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0034
Criticality: Q
Description: There must be logging of failed login attempts.
Rationale: Related to IT security.

Confluence/Comala Document Manager: Yes/No/Partial

Audit Trail

URS-Con-0035
Criticality: Q
Description: The system must support audit trails for:

• GxP data, associated metadata, electronic signatures. The audit trail must be stored and retrievable throughout the data lifecycle for GxP data.
• The audit trail must be available in a readable format.
• The audit trail must be protected against deletion and changes.
  Rationale: EU GMP annex 11 section 9 and GAMP5 2nd edition section 17.3.5.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0036
Criticality: Q
Description: The audit trail must log:

• Who
• When
• What (action – e.g., change, creation, or deletion)
• Why
  Rationale: EU GMP annex 11 section 9.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0037
Criticality: Q
Description: It must be possible to search the audit trail.
Rationale: GAMP5 2nd edition section 17.3.4.

Confluence/Comala Document Manager: Yes

URS-Con-0038
Criticality: C
Description: It must be possible to generate a report of all changes within a given time frame (e.g., changes made in the last 24 hours).
Rationale: To increase usability.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0039
Criticality: Q
Description: It must be possible to trace the history of a document from creation to archiving, including all changes and approvals.
Rationale: EU GMP annex 11 section 9 and GAMP5 2nd edition section 17.3.5.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0040
Description: Changes in roles on a document must be logged in an audit trail, and the reason for the change must be recordable and visible.
Rationale: Only authorized personnel may approve and date documents (EU GMP 4.3).

Electronic Signature

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0041
Criticality: Q
Description: The system must support electronic signatures:

• The signature must be permanently and uniquely linked to the document/data to which the signature belongs.
• The signature must include a date and timestamp.
  Rationale: EU GMP annex 11 section 14.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0042
Criticality: Q
Description: There must be an electronic signature on all approvals in the system.
Rationale: EU GMP annex 11 section 14.

Reports and Outputs

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0043
Criticality: C
Description: The system must be able to generate a list of documents sent for approval that are still pending approval.
Rationale: Used for management and overview of outstanding tasks.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0044
Criticality: C
Description: The system must be able to report within a given time interval which documents need updating and by whom.
Rationale: Used for management and overview of outstanding tasks.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0045
Criticality: Q
Description: It must be possible to print documents in a readable format, including all entries made throughout the document's lifecycle.
Rationale: EU GMP chapter 4 Principle.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0046
Criticality: Q
Description: It must be possible to generate complete copies of all types of documents, both for physical printing and in electronic form in a format suitable for review and approval.
Rationale: EU GMP chapter 4 Principle.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0047
Criticality: C
Description: A system diagram must be available.

Confluence/Comala Document Manager: Yes/No/Partial

Data

Requirements for data handling focused on patient safety, product quality, and data integrity.

URS-Con-0048
Criticality: Q
Description: Data must be secured both physically and electronically against damage. Stored data must be checked for availability, readability, and accuracy. Access to data must be secured throughout the entire storage period.
Rationale: GAMP5 2nd edition section 17.3.7.

Confluence/Comala Document Manager: Yes/No/Partial

Data Migration

Requirements for migrating data between interfaces/integrations to other processes or tools.

URS-Con-0049
Criticality: Q
Description: It must be possible to import and export data to and from the system.
Rationale: Used for management and overview of outstanding tasks.

Confluence/Comala Document Manager: Yes/No/Partial

Backup and Recovery

Requirements for data restoration in case of data loss due to unintended incidents such as hardware or software failures.

URS-Con-0050
Criticality: Q
Description: Data must be restorable from backup.
Rationale: EU GMP section 7.2.

Confluence/Comala Document Manager: Yes/No/Partial

Performance

URS-Con-0051
Criticality: Q
Description: The system must be able to integrate with JIRA, i.e., data must be transferable to JIRA.

Confluence/Comala Document Manager: Yes/No/Partial

Capacity

URS-Con-0052
Criticality: C
Description: It must be possible for a minimum of 5 internal users to use the system simultaneously.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0053
Criticality: Q
Description: It must not be possible for two users with the same role to edit a document simultaneously.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0054
Criticality: C
Description: In the long term: It must be possible to handle multiple types of documents, such as:

• Deviations
• CAPA reports
• Training records and management
• Change cases
• Supplier management
• Risk assessments
  It must be possible to configure these regarding workflow, access, and approval. The requirements for these documents are equivalent to the requirements in the rest of the URS for procedures, instructions, and templates.

Confluence/Comala Document Manager: Yes/No/Partial

Configuration

Requirements for configuring functionalities/standard processes

URS-Con-0058
Criticality: Q
Description: The system must be subject to configuration management.
Rationale: EU GMP annex 11 section 10.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0059
Criticality: C
Description: It must be configurable that documents must be reviewed at a fixed interval (e.g., every 3 years).
Rationale: To ensure the review period for current documents and thus ensure they are always current and reflective of the actual workflow.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-0060
Criticality: C
Description: There must be a notification when a document is routinely due for review. This must be configurable (i.e., how long in advance, to which role the notification should go).

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-X001
Criticality: C
Description: It must be possible to create Microsoft Office document types or documents that have the same functions as the Microsoft Office suite, e.g., Word (=Page), Excel, PowerPoint.

Confluence/Comala Document Manager: Yes/No/Partial

URS-Con-X002
Criticality: C
Description: It must be possible to save all types of documents in the system as PDF

Confluence/Comala Document Manager: Yes/No/Partial

[Kristian Klima · Accepted solution]

Hi @Conni Drejer 

You know, people charge a fortune for reviews like that :D 

On a serious note, I gave it a quick glance and I'd say that most questions are Yes (the LEVEL of that yes may vary in some cases).

Disclaimer: I'm using a Comala solution, I know of deployments with very similar requirements, and I'm using apps I'm referencing.

004 - Yes if you add Scroll Documents by K15t.

027 - yes with Confluence Guests

033 - not sure

038 - yes, there are apps, macros, Confluence Database

044 - yes, probably in Comala, or Confluence automation

045 - check Scroll PDF exporter by

048 - refer to Confluence ToC or discuss this with their compliance dept.

X002 - check Scroll PDF exporter

Note: There's also Comala Document Control app which differs slightly from Document Manager and there's a certain overlap.

[Conni Drejer]

Thank you very much - I will use your answers as an addition to our own test-results.

[Chris Cairns - Digital Rose]

Hi @Conni Drejer  Comala and Scroll are popular and successful apps.   As @Kristian Klima shared, the combination of Comala with addons plus Scroll Documents and Scroll Xporter appears to meet most of your team's requirements.

If your requirements are not fully met, or if a single app solution is appealing perhaps consider our eSign app.

eSign Document Management & Training is a Confluence document control system for teams that need a QMS solution for high compliance environments (e.g. GXP, ISO, Part 11).  It has robust electronic signatures, formal revision management, approval records, user training records, audit trails, etc.  Managing multiple versions of the same document with cross-space publishing, release and obsoletion is a built-in feature of eSign.  

Please reach out to our support team (support@esign-app.com) for assistance with a demo, free trial,  or any help reviewing your requirements against eSign Documents. 

Chris Cairns
Digital Rose (vendor of the eSign apps)

[Conni Drejer]

Thank You - we will take your advices into consideration.