Digital Quality Management and Quality Data Governance

Programme Summary

Design digital quality workflows that preserve reliable evidence and improve practical decision making. Participants map quality data, define ownership and evaluate controls for electronic records, automated checks and reporting. A system improvement case addresses requirements, access, validation and change, helping teams adopt useful technology while maintaining traceability, human accountability and clear limits on automated recommendations.

Training Objectives

1 Connect digital quality tools with process needs; 2 Define reliable data ownership and lifecycle controls; 3 Evaluate automation risks and validation evidence; 4 Strengthen access traceability and change management; 5 Prioritise practical digital quality improvement opportunities.

Learning Outcomes

1 Map a quality data lifecycle; 2 Define testable digital workflow requirements; 3 Identify data and automation control gaps; 4 Prepare a risk based validation checklist; 5 Present a practical digital quality improvement plan.

Target Audience

Quality Systems Managers; Digital Quality Leads; Quality Data Analysts; Quality Assurance Managers; Business Systems Owners.

Target Industries

Manufacturing; Pharmaceutical Manufacturing; Medical Device Manufacturing; Food Manufacturing; Industrial Services; Contract Laboratories.

Course Contents

• Module 1 Digital Quality Purpose: Process problems and useful technology choices; Electronic quality workflows and accountability; Benefits assumptions and implementation priorities.
• Module 2 Quality Data Governance: Critical records definitions and data ownership; Data lineage context and quality checks; Retention privacy and access responsibilities.
• Module 3 Workflow Requirements: Complaints deviations actions and approvals; Testable user requirements and acceptance criteria; Interfaces with operational and supplier systems.
• Module 4 Automated Checks and Analytics: Rules alerts and decision support limits; False signals missing data and model drift; Human review of significant quality decisions.
• Module 5 System Validation and Assurance: Risk based testing of critical functions; Calculation interface and permission verification; Defects acceptance and retained test evidence.
• Module 6 Access and Record Integrity: Unique identities roles and segregation; Audit trails controlled changes and approvals; Backup recovery and reliable retrieval.
• Module 7 Implementation and Change: Pilot scope training and transition controls; Change impact and regression testing; Performance review and continuous improvement.
• Module 8 Digital Quality Case Workshop: Assessing a workflow and data risks; Preparing requirements and validation checks; Presenting a staged improvement proposal.

Assessment

• 40 single best answer questions, including applied scenarios; one mark per question.
• 60 minute invigilated digital examination with identity verification. Approved accessibility adjustments preserve the assessed competence.
• Supplied reference pack and calculator permitted; external internet and AI prohibited.
• Individual applied assessment (30 minutes): Assess a fictional digital quality workflow and produce requirements, data controls and a validation checklist for a prioritised improvement.
• Assessment criteria: Process aligned requirements and ownership; Appropriate data and automation controls; Practical validation and implementation judgement.
• Pass each component separately: 30/40 written marks (75%) and at least 70% on the applied task.
• Individual results and feedback are provided. One reassessment may follow coaching under the published enrolment terms.

Certification

• Successful learners receive a TQCSI Arabia digital Certificate of Successful Completion.
• The certificate records the learner name, exact programme title, teaching hours, completion date and unique verification reference.
• Verified identity, full attendance and separate written and applied passes are required; all mandatory critical criteria must be met.
• Proposed issue target: within 30 calendar days of approved results and settlement of applicable fees.
• Records digital quality governance learning; it does not certify software, validate an organisational system or authorise automated quality decisions.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

222

Total teaching hoursTotal teaching hoursTotal teaching hours

12 hours; breaks, pre course work and formal final assessments excluded.12 hours; breaks, pre course work and formal final assessments excluded.12 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 20 delegates.Maximum 20 delegates.Maximum 20 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

Quality management experience and familiarity with electronic records are required. Basic understanding of business systems and data analysis is recommended.Quality management experience and familiarity with electronic records are required. Basic understanding of business systems and data analysis is recommended.Quality management experience and familiarity with electronic records are required. Basic understanding of business systems and data analysis is recommended.

Pre course assignment and assessmentPre course assignment and assessmentPre course assignment and assessment

Review a fictional digital quality workflow for 25 minutes and identify data owners, transfers and critical decisions.Review a fictional digital quality workflow for 25 minutes and identify data owners, transfers and critical decisions.Review a fictional digital quality workflow for 25 minutes and identify data owners, transfers and critical decisions.

End of course assessmentEnd of course assessmentEnd of course assessment

40 question written exam (60 minutes) and individual applied task (30 minutes).40 question written exam (60 minutes) and individual applied task (30 minutes).40 question written exam (60 minutes) and individual applied task (30 minutes).

Passing criteriaPassing criteriaPassing criteria

75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.