Key roles for on-going operation of SOLABS QM10

Role​s

Responsibilities​

 System Owner​

 Ensure the system is configured, validated, used, and maintained in a manner consistent   with written policies, procedures, and regulations.​

• Manage system upgrades/fixes; ​
• Manage change control;​
• Define procedures;​
• Set System support and incident management.​

 Has a full knowledge of the Setup section, and is assigned the System and Document   Administrator roles in SOLABS QM10 in order to:​

• Maintain the Security Roles in accordance with the organizational chart;​
• Manage the configuration of the system (Roles, Users, Document Types, Document Workflow templates, PDF rendering templates, System configuration and System attributes and List);​
• Manage privileges on folders and documents.​

 IT Specialist

• Provide resources for the validation and maintenance activities.​
• Support system owner in Level 1 and 2 incident management.​
• Backup to System Owner (or principal) for the administration of users and privileges in the system. ​
• Can unlock users. 

 Document   Coordinator &​

 Training   Coordinator​

Has a full knowledge of the Document and Training sections, and is assigned the Document and/or Training Coordinator roles in SOLABS QM10. Understands the Document Control process (Document Control Process General Overview   (P0007)).​

• Process Document Control Requests from request until document approval.​
• Manage folder structure ​and privileges 
• Manage training curriculum, training activities and job title profiles;​
• Assign training ​to end-users. ​
• Can unlock users. 

 Process Owners ​

 CAPA, Change   Control, etc.)​

 Has full knowledge of the QM APPs in operations e.g. CAPA, Change   Control, Deviations, Complaints, Audits, and Lab Investigations:​

• Expert in the workflows and logic of the process(es).  ​
• Manage privileges in the process section. ​
• Can re-assign tasks. ​
• Follow-up on open processes. ​

 Head of   Department ​

• Request user access or deactivation for SOLABS QM10 system.​
• Follow-up on open items within their department.

 User​

• Use the system ​and maintain up-to-date training records 
• Inform System Owner and IT Specialist of any issue with the software​