96061 Computer Systems Validation Principles and Practices
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Subject handbook information prior to 2025 is available in the Archives.
Credit points: 6 cp
Result type: Grade and marks
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
Description
Information technology is a rapidly evolving field, and the development processes for information technologies are shifting equally fast. In this subject students review Computer System Validation (CSV) methodologies for changing environments, and navigate through guidance and current industry best-practices related to Good Automated Manufacturing Practices (GAMP). Students examine all stages of the software development lifecycle, including electronic records, electronic signatures, current regulatory requirements, and computer systems validation documentation and testing. Finally, students assess the criticality of computer systems validation to pharmaceutical manufacturing.
Subject learning objectives (SLOs)
| 055. | Adapt CSV principles to new environments |
|---|---|
| 056. | Assess, predict outcomes and explain opportunities for improvement of given Computer System Validation (CSV) case studies |
| 057. | Compare each stage of the software development life cycle |
| 058. | Construct a supplier audit appropriate to the audit scope |
| 059. | Describe the structure and characteristics of a supplier audit |
| 060. | Develop an approach for bringing software systems into compliance with 21 CFR Part 11, including incorporation of GMP requirements |
| 061. | Explain the categories used in Good Automated Manufacturing Practices (GAMP), what level of CSV applies to each category, and how to determine the appropriate category for a given system |
| 062. | Identify and evaluate the key strengths and weaknesses of Computer System Validation (CSV) processes to plan the selection and implementation of a software system |
| 063. | Prepare documentation requirements for the implementation of a GMP software system to a standard ready for tender |
Contribution to the development of graduate attributes
This Subject combines the knowledge, skills and attributes acquired throughout the Master of Good Manufacturing Practice (MGMP), and applies them to the computer systems that are increasingly relied on to implement and control pharmaceutical quality.
Concepts of previously completed subjects 96068 Validation Principles and 96064 Risk Management for Pharmaceutical Operations are applied to the strategic planning and decision-making throughout all phases of the computer system validation lifecycle in a GMP environment.
Through GAMP, this Subject combines the core concept of GMP with computer systems to promote the lesson that quality cannot be ensured by testing alone; rather it requires validation and compliance at all stages and of all aspects of the manufacturing process.
This Subject contributes towards developing the following Graduate Attributes:
Lifelong learning:
Graduates of the Master of GMP are lifelong learners, committed to and capable of reflection and inquiry in their quest for personal development and excellence in professional practice.
Professional capacity:
Graduates of the Master of GMP are industry-focused, ethical practitioners with the understanding and proficiency to be leaders in their profession, capable of effectively analysing and implementing solutions in a global context under international regulatory guidelines.
Global citizenship:
Graduates of the Master of GMP contribute to society, resolving to undertake those actions and responsibilities that will enhance their role in local, national and global communities.
Teaching and learning strategies
On campus (standard) mode: This subject will be delivered on the City campus and requires attendance for three hours of face-to-face contact per week, as well as approximately 1-3 hours of personal study pre-work before each class. However, should restrictions related to COVID-19 require it, classes for this subject will be conducted online. The format and content of online classes (should they be required) will be equivalent to face to face on-campus classes and the same attendance requirements apply.
Online (distance) mode: This subject is delivered online via Canvas. Students are required to contribute to weekly discussions as well as participate in occasional online meetings via zoom when required. Students should dedicate approximately 3-6 hours of time to this subject per week. Students will learn in this Subject through online content comprising videos, set reading, directed research, activities online discussions and self-check quizzes. This independent learning will be supported by group learning experiences, in which ideas and concepts can be tested and refined
Strategy 1: Student directed learning: Students read articles and use online resources, such as online course material, videos, directed research, activities, self-check quizzes and case studies, provided via Canvas. This learning prepares students for their participation in activities that may include facilitated discussion of fundamental concepts drawn from course materials and solutions to industry case studies, assessable quizzes or activities as well as collaborative and interactive learning experiences.
Strategy 2: Collaborative and interactive learning experiences: Provide the students with the opportunity to engage with Peers and Academics to discuss and clarify concepts for a deeper understanding of online course materials.
On campus students - engage in a weekly 3 hour workshop. Each workshop aims to apply online course materials to real life pharmaceutical industry scenarios through discussions and problem solving in collaboration with fellow students.
Online students – engage in weekly discussion forums. Each online discussion aims to apply course material in real life pharmaceutical industry scenarios and collaboration with fellow students is required by posting and responding to other students posts in the discussion forum. Students participate in the online discussions by writing their comments in the Canvas platform in their own time and also read and respond to posts from peers. Each discussion has an end time designated by which students must have contributed.
Strategy 3: Early and consistent feedback: Early feedback is provided prior to the census date.
On campus students – receive feedback in workshops or via the Canvas platform for activities. Feedback regarding the quizzes is provided following each quiz, via provision of answers and/or in-class review. The collaborative learning approach utilised in class will enable ongoing feedback to be provided in class, as areas of learning need are identified through class discussions.
Online students – receive feedback during ‘open office’ hours and discussion forums. Feedback regarding the self-check quizzes is provided via Canvas immediately upon submission of each quiz. The collaborative learning approach will enable ongoing feedback to be provided to students, via teacher responses to posts, as areas of learning need are identified through online discussions.
Strategy 4: Group work: students work in groups during collaborative and interactive experiences. Students will need to coordinate group work, fostering negotiation, team building and teamwork skills. Students will need to demonstrate the ability to respond respectfully and constructively to their peers, fostering communication, constructive criticism and and respect for diverse ways of working.
Strategy 5: Students are encouraged to critically reflect on their learning throughout the subject to identify areas where they may improve their performance and develop lifelong learning skills.
Content (topics)
This Subject will commence with information about the applicable regulations and an introduction to Good Automated Manufacturing Practice (GAMP). You will then learn about System Development Life Cycles and Risk Assessment followed by an in depth look at each stage: Infrastructure Qualification and Planning; Pre-development; and Development, Testing, Qualification and Use. In the final part of the course you will learn about compliance with 21 CFR Part 11 and application of CSV in Cloud Computing.
Assessment
Assessment task 1: On-going Graded Assessment
| Intent: | Throughout the semester you will have the opportunity to check your understanding of the course content via graded assessments through the Canvas platform. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 055, 056, 057, 059, 060, 061 and 062 This task is aligned with the following course learning outcomes: .01, .03, .05, .08, .09 and .11 |
| Groupwork: | Individual |
| Weight: | 15% |
| Criteria: | Provided via Canvas |
Assessment task 2: Project: Supplier Audit Plan
| Intent: | The preparation of a supplier audit plan is a real task that a student of this subject may be asked to do in their subsequent employment. Students will be provided with authentic background information on a computer systems supplier and asked to prepare a suitable audit plan. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 058 and 059 This task is aligned with the following course learning outcomes: .01, .03, .06 and .11 |
| Type: | Project |
| Groupwork: | Individual |
| Weight: | 25% |
| Length: | Report 500 words; Audit plan 1-2 pages (may be in the form of a checklist) |
| Criteria: | Published in the Assessments section of Canvas for this subject. |
Assessment task 3: Spreadsheet Validation
| Intent: | This assessment provides students with a realistic workplace scenario in which they design a simple spreadsheet to meet an established URS and then test a spreadsheet to ensure the URS is met. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 056, 062 and 063 This task is aligned with the following course learning outcomes: .03, .05, .06, .08, .09 and .11 |
| Type: | Project |
| Groupwork: | Group, individually assessed |
| Weight: | 35% |
| Length: | Each team is to submit their spreadsheet file (in .xls format) and at least one test script for each point of the URS. |
| Criteria: | Published in the Assessments section of Canvas for this subject. |
Assessment task 4: Validation of a Cloud Provider
| Intent: | A move to ‘cloud computing’ is becoming more usual in the pharmaceutical sector. This assessment provides students with a practical opportunity to evaluate and report on the validation requirements of such a change. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 055 and 056 This task is aligned with the following course learning outcomes: .01, .03, .05, .06 and .11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 25% |
| Length: | 750-1000 words |
Minimum requirements
On Campus Mode
In order to pass this Subject, a minimum grade of 50% must be achieved.
Students are required to attend a minimum of 85% of classes, and submit all assessment tasks
Online Mode
In order to pass this Subject, a minimum grade of 50% must be achieved and students must submit all assessment tasks.
Required texts
Coursework Assessments Procedures
Graduate School of Health Policy, Guidelines and Procedures (login required)
Additional required readings will be provided via Canvas
Recommended texts
The PIC/s Code of GMP, Annex 11