Module Details

Module Code: CHEA8006
Title: Chem. Info. & Data Validation
Long Title: Chemical Informatics & Data Validation
NFQ Level: Advanced
Valid From: Semester 1 - 2019/20 ( September 2019 )
Duration: 1 Semester
Credits: 5
Field of Study: 4424 - Analytical Chemistry
Module Delivered in: 1 programme(s)
Module Description: This module covers various aspects of TQM including advanced management system involving the traceable management of analytical data through the use of computerised systems, data system validation and integrity for the maintenance of, and the assurance of, the accuracy and consistency of data over its entire life-cycle, a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Advise on the selection, purchase, installation and operation of an informatics system in the context of regulatory compliance for the BioPharmaChem industry
LO2 Describe the use of computerised systems for Total Quality Management in modern laboratory operations
LO3 Integrate laboratory information: management systems, regulations, responsibilities, data analysis, data treatment and data validation.
LO4 Investigate the implementation of analytical SOPs into a laboratory information management system and design systems to ensure data traceability and regulatory compliance.
LO5 Prepare and disseminate a chemical informatics project.
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
No requirements listed
 
Indicative Content
Characteristics of Laboratory Operations
Overview of laboratory processes and data/information workflow in quality control, analytical services and pharmaceutical laboratories, in a regulated environment.
Impact on the Laboratory
Work practices, training, responsibilities, QMS integration, TQM, validation requirements, security protocols, sample chain of custody.
Laboratory Computer Utilisation
Instrument automation and robotic systems. Analytical data and information management including control, security and traceability.
Informatics Fundamentals
The information process, specifications, data system validation. Practical Informatics: hardware, implementation and verification plan and long term QC of system. Data integrity theory and application.
Regulatory Requirements
Laboratory accreditation: ISO, EPA, and FDA Standards. Good Automated Laboratory Practices (GALP), Good Manufacturing Practices (cGMP), Access Levels, ICH validation requirements. Audit and review.
Module Content & Assessment
Assessment Breakdown%
Coursework100.00%

Assessments

Coursework
Assessment Type Other % of Total Mark 20
Timing Week 6 Learning Outcomes 1,2,3
Assessment Description
Report on a Pharmaceutical site visit or on a powerpoint presentation delivered by a quality systems expert
Assessment Type Short Answer Questions % of Total Mark 30
Timing Week 12 Learning Outcomes 1,2,3,4
Assessment Description
Theory test
Assessment Type Project % of Total Mark 50
Timing Sem End Learning Outcomes 1,2,3,4
Assessment Description
Informatics project and presentation
No End of Module Formal Examination
Reassessment Requirement
Coursework Only
This module is reassessed solely on the basis of re-submitted coursework. There is no repeat written examination.

The University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecturer-Supervised Learning (Contact) Contact Computer focused lectures on chemical informatics & data integrity Every Week 1.00 1
Lab Contact Computer focused project on LIMS, ICH guidelines & Data Integrity Every Week 2.00 2
Independent & Directed Learning (Non-contact) Non Contact Personal study Every Week 4.00 4
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecturer-Supervised Learning (Contact) Contact Computer focused lectures on chemical informatics & data integrity Every Week 1.00 1
Lab Contact Computer focused project on LIMS, ICH guidelines & Data Integrity Every Week 2.00 2
Independent & Directed Learning (Non-contact) Non Contact Personal study Every Week 4.00 4
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 
Module Resources
Recommended Book Resources
  • Christine Paszko, Elizabeth Turner. (2002), Laboratory information management systems, Second Edition, Revised and Expanded. Marcel Dekker, New York, [ISBN: 978-0824705213].
  • Daniel F. Cowan, editor. (2003), Informatics for the clinical laboratory, Springer, New York, [ISBN: 978-0387953625].
  • Louis M. Mezei. (1992), Practical laboratory information management for scientists & engineers, Prentice Hall, Englewood Cliffs, N.J., [ISBN: 978-0136781868].
Supplementary Book Resources
  • Allen S. Nakagawa. (1994), LIMS, implementation and management, Royal Society of Chemistry, Cambridge, [ISBN: 978-0851868240].
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_SCHQA_8 Bachelor of Science (Honours) in Analytical Chemistry with Quality Assurance 8 Mandatory