Laboratory Information Management Systems and Computerised System Validation

Programme Summary

Plan laboratory information systems that support reliable workflows, controlled data and traceable decisions. Participants translate laboratory needs into risk based requirements, validation tests and operating controls. A system lifecycle case addresses interfaces, calculations, access, changes and recovery, producing practical evidence for acceptance while keeping ownership of technical results and data governance clear throughout implementation and routine use.

Training Objectives

1 Translate laboratory workflows into system requirements; 2 Apply risk based computerised system validation; 3 Protect critical data calculations and interfaces; 4 Define sustainable access change and recovery controls; 5 Strengthen evidence for system acceptance decisions.

Learning Outcomes

1 Draft testable laboratory system requirements; 2 Prepare a risk based validation plan; 3 Write a critical function test script; 4 Assess a system change and retest scope; 5 Present a supported system acceptance recommendation.

Target Audience

Laboratory Systems Owners; Laboratory Quality Managers; Validation Specialists; Laboratory IT Analysts; Technical Managers.

Target Industries

Pharmaceutical Laboratories; Contract Testing Laboratories; Environmental Laboratories; Food Testing Laboratories; Industrial Calibration Laboratories.

Course Contents

• Module 1 Laboratory System Lifecycle: System ownership and intended laboratory use; Data flows and process interfaces; Risk based lifecycle documentation.
• Module 2 User Requirements: Sample workflows and technical decision needs; Functional security and retention requirements; Clear acceptance criteria and traceability.
• Module 3 Risk Assessment: Critical data and calculation functions; Failure scenarios and laboratory consequences; Risk controls and test priorities.
• Module 4 Supplier and Configuration Review: Supplier evidence and service responsibilities; Configuration specifications and controlled settings; Cloud service and support considerations.
• Module 5 Validation Planning: Scope deliverables and approval responsibilities; Test strategy and representative datasets; Requirements to test traceability.
• Module 6 Functional Testing: Sample identity workflow and status controls; Calculation rounding and unit conversion checks; Reports certificates and authorised release tests.
• Module 7 Data and Interface Testing: Import export and transfer reconciliation; Metadata preservation and migration checks; Audit trail and timestamp verification.
• Module 8 Access and Electronic Approval: Role permissions and account lifecycle; Segregation of duties and privileged access; Approval identity and controlled delegation.
• Module 9 Resilience and Recovery: Backup design and restoration testing; Failure handling and continuity procedures; Data retention retrieval and archival checks.
• Module 10 Deviations and Acceptance: Recording failures and risk assessments; Correction retesting and residual risk decisions; Approved validation summary and release.
• Module 11 Operational Control and Change: Periodic review and incident management; Change impact and regression testing; Retirement migration and retained evidence.
• Module 12 System Validation Workshop: Developing requirements and test scripts; Evaluating a critical test deviation; Presenting a justified acceptance decision.

Assessment

• 60 single best answer questions, including applied scenarios; one mark per question.
• 90 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 (45 minutes): Prepare system requirements, a risk assessment and three validation test scripts; evaluate a failed test and recommend acceptance or corrective action.
• Assessment criteria: Requirements aligned with laboratory risks; Test coverage and traceable evidence; Sound acceptance and change judgement.
• Pass each component separately: 45/60 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 laboratory system validation planning skills; it does not certify software, confer cybersecurity approval or authorise laboratory result release.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

333

Total teaching hoursTotal teaching hoursTotal teaching hours

18 hours; breaks, pre course work and formal final assessments excluded.18 hours; breaks, pre course work and formal final assessments excluded.18 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 16 delegates.Maximum 16 delegates.Maximum 16 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

Laboratory process knowledge and experience with digital laboratory records are required. Basic understanding of system testing or quality assurance is recommended.Laboratory process knowledge and experience with digital laboratory records are required. Basic understanding of system testing or quality assurance is recommended.Laboratory process knowledge and experience with digital laboratory records are required. Basic understanding of system testing or quality assurance is recommended.

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

Review a fictional laboratory system workflow for 30 minutes and identify critical data transfers and calculations.Review a fictional laboratory system workflow for 30 minutes and identify critical data transfers and calculations.Review a fictional laboratory system workflow for 30 minutes and identify critical data transfers and calculations.

End of course assessmentEnd of course assessmentEnd of course assessment

60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 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.