Validation

The pharmaceutical and associated industries demand compliance to different regulatory requirements. To achieve this people in these industries need training and certification. imc's Learning Management System imc Learning Suite is already used by customers which underlie regulatory requirements defined by the U.S Food & Drug Administration (FDA). More concrete FDA has published "CFR - Code of Federal Regulations Title 21 - PART 11 Electronic Records; Electronic Signatures" which defines binding regulatory requirements. The most up-to-date version of CFR Title 21 can be found here. More concrete part 11 can be found here (accessed November 27, 2017).

The concrete regulations which apply for a customer using imc Learning Suite for their training management differ from customer to customer. imc AG offers to partner up for a validation of imc Learning Suite with customers in each concrete customer context of FDA relevant workflows underlying CFR 21 Part 11 which are supported by imc Learning Suite used by the concrete customer. This is to say that imc Learning Suite itself is NOT and cannot be a FDA validated system for itself. It is to say that imc Learning Suite can be used for concrete processes on customer side to fulfill regulatory requirements which are concretely given for the customer.

Following that approach imc Learning Suite can be validated for any customer. This validation must be prepared by analysing the concrete learning management workflows of the customer to identify regulatory needs and see whether the system functions at hand do cover those needs already.

Configuration and Effects

The following chapter describes the setup and the consequences for the system and the dedicated objects.

System Setup

Overall activation of the validation feature in system is done in the file "businessprocess.xml":
- Without this parameter no tracking and no eSignature will be done at all
- Without this parameter no element can be marked as validation relevant
- Parameter: <validation active="true"><esignature active="true" /></validation>
eSignature feature needs to enabled explicitly also in "businessprocess.xml":
- Parameter: <validation active="true"><esignature active="true" /></validation>
Time window for eSignature is set by default to 30 and can be configured in "businessprocess.xml":
- Parameter: <validation active="true"><esignature active="true" expirationSeconds="600"/></validation>

Common Configuration and Effects

Setting a system to audit relevant will result in disabling the reuse of logins for audit relevant systems. Setting an element to validation relevant will have several effects. The common effects are:

Validation relevant objects cannot be deleted
Validation relevant objects will be tracked. By default the following changes are tracked:
- Creation
- ACL Changes
- Changes of the audit relevant attribute
eSignature (if enabled) is needed to change a validation relevant object.

Client Setup

Each client which is validation relevant needs to be marked by ticking the checkbox
Each user whose default client is validation relevant
Default: Not ticked
Specific tracking:
- Assignment of users to clients

Group Setup

Each group (system/BU/target group) which is validation relevant needs to be marked by ticking the checkbox
Default: Not ticked
Specific tracking:
- Assignment of users to groups
- Attribute changes:
  - Type of role
  - Function
  - Status

User Setup

Each user whose default client is validation relevant
Specific tracking:
- Attribute changes:
  - First name
  - Name
  - Login
  - Main client
  - Authentication status

Course Type Setup

Cannot be set to validation relevant
Default value for courses can be set using the validation relevant meta tag

Course Template Setup

Each course template which is validation relevant needs to be marked by ticking the check box
Default: Not ticked
Specific tracking:
- New version created

Course Setup

Each course which is validation relevant needs to be marked by ticking the check box of the meta tag "validation relevant"
Default: Not ticked, but default can be changed on course template level
Meta tag "validation relevant" is not added to courses automatically
Specific tracking
- Attribute changes:
  - All meta tags which are marked as validation relevant
- Contents
- Learning logic
- Prerequisites
- Skills
- Tutors
Specific effects
- Disable course set creation for audit relevant objects
- Disable automatic update of syllabus components
- Disable course specific media for audit relevant objects

Media Type Setup

Each media type which is validation relevant needs to be marked by ticking the check box
Default: Not ticked
Specific tracking:
- No specific tracking

Media Setup

Each media which is validation relevant needs to be marked by ticking the check box of the meta tag "validation relevant"
Default: Not ticked, but default can be changed on media type level
Meta tag "validation relevant" is not added to media automatically
Specific tracking:
- New version created
Specific effects
- Disable updates of SCORM and AICC WBTs for audit relevant objects

Test Template Setup

Each test template which is validation relevant needs to be marked by ticking the checkbox of the meta tag "validation relevant"
Specific tracking:
- New version created

Test Setup

Each test which is validation relevant needs to be marked by ticking the checkbox of the meta tag "validation relevant"
Specific tracking:
- New version created

Skill Setup

Each skill which is validation relevant needs to be marked by ticking the checkbox
Specific tracking:
- Attribute changes:
  - Status
  - Evaluation through the following scale
  - Linked scale
  - Numerical evaluation
  - Confirmation mode
  - Scheduling
- Skill scale changes:
  - Level

Skill Scale Setup

Each skill scale which is validation relevant needs to be marked by ticking the checkbox
Specific tracking:
- Attribute changes:
  - Level

Meta tag Setup

Each meta tag which is validation relevant needs to be marked by ticking the checkbox
Specific tracking:
- No specific tracking

Navigation Item Setup

Each navigation item which is validation relevant needs to be marked by ticking the checkbox
Specific tracking:
- Access rights
- Attribute changes (general):
  - identifier
  - menu type
  - Default menu (if menu type is default menu)
  - Settings (if menu type is default menu)

Audit Reporting

For an audit the following reports are used to provide the necessary data:

Audit trail (report)
- Information about the state of an object (e.g. skill, course, course syllabus, media) at a specific time
- Information about the permission on an object (e.g. skill, course, media) at a specific time
- Information about the functional rights (e.g. create, edit) at a specific time
Skill history (functionality in staff pool)
- Information about the levels of an user and their reasons at a specific time
Audit log
- Information about the enrolment states of a user and their reasons at a specific time

Further System Configurations to Ensure a Validated System

The following configurations MUST be done to ensure a validated system:

Area	Action	Reason
Course	For the following meta tags it needs to be ensured that they cannot be configured for courses: This can be achieved by adjusting the ACLs, so these meta tags are not available for validated systems	By using this function no tracking or eSignature is done
Course	The following navigation items needs to be removed for validated systems: This can be achieved by adjusting the permissions of the course manager	By using this function no tracking or eSignature is done

Additional Notes

Changes on users will not to be tracked if master client NOT validated client. Since users of other client could perform validated courses and therefore changes need to be tracked as well.
Reactivate users after deletion not possible (since login needs to be unique over all users (including deleted users))
eSignature if course completed by Learner
eSignature when creating an external course via the module "simplified course creation" (ECC) for validated systems
Target groups will not be added to log
Script to add new meta tag "validation" to already existing courses is needed
Tracking and eSignature only if object marked as "validation"
Changes on clients will not be tracked
No delete for validation relevant objects
No SCORM or AICC update possible
No course specific media objects
No automatic update for objects in syllabus
Currently no sub-courses possible
Not possible to save users if already deleted users exists with same login
Only users in group function "Validation" can change validation relevant check box
Target groups should not be used
Meta tag for validation can be added to course type / media type etc. based on this the meta tag will also part of course created out of course type and courses although "meta tag on description page of course type" not → Check setup