COMPUTER SYSTEM

VALIDATION
TRAINING

Operation

Planning

Specification Verification

Online [Link] | Email contact@[Link]

Phone +66 2630 4525 | Fax +66 2630 4527
 THIS IS INDUSTRY’S ONE STOP SHOP FOR
VALIDATION TRAINING, YOU CAN CREATE YOUR
OWN TRAINING EVENT BY SELECTING FROM
THE FOLLOWING EIGHT INTERACTIVE SESSIONS.

PROGRAM: M Management Q Quality T Technical

Session 1 Establishing a Computer Systems Validation Roadmap

I. Validation as part of the Quality Key information is presented about all
Operation
Management System (based on these topics and about project plan
PICS) considerations, risk management, use of
Planning tests, appropriate criteria, timing and
II. Validation Master Planning responsibilities
Specification Verification
Validation master planning includes the III. Workshop case study:
following topics: Participants work in groups to
• Process control develop a computer validation
• Equipment control master plan for an oral liquid
• Data Computers product
• Training
• Documentation
• Change Control
• Role of QA
Duration: 3 hours

M Q

Session 2 Regulations (PIC/S) for Computer Systems

I. Regulations • Specifications
Operation • Summary of the PICS regulations • Verification Testing Protocols
Planning for computerised systems including IQ/ OQ/ PQ
• Requirements of EU Annex 11 for • Validation results
Computerised Systems • Validation reports
Specification Verification • PICS require ments for quality
management systems and III. Document Management
validation
IV. Other Key Documents
II. Validation Documentation • Periodic review
Hierarchy and Contents • Change control
• Corporate policy • Calibration
• Computer Validation Master Plan
(VMP) and computer inventory V. Workshop case study:
• User requirements specification Participants develop the
Duration: 3 hours
• Individual validation plans documentation for an example
• Risk analysis project
M Q
Gap Analysis for Computer Systems Validation (PIC/S) Session 3
I. Learn How to Plan a Gap • Specifications
Analysis • Verification testing, and acceptance Operation
• Develop a gap analysis criteria
Planning
• Plan conduct the gap analysis
• Roles and responsibilities III. Correcting Deficiencies
• Tools for a typical assessment • Identify documentation deficiencies Specification Verification
• Determine the methodology to use • Apply risk-based remediation
• Prepare for issues that may be • Record observations and
found addressing problem areas
• Revalidation planning
II. What Inspectors Are Looking For • How to determine if you are
• Current requirements and compliant
expectations
• Policies, plans, test protocols, risk IV. Workshop case study: Participants
analysis carry out a gap analysis of a Duration: 3 hours
• Lifecycle approach to process previous validation program
computer validation M Q

The Importance of Good Specifications for Computer Systems Session 4

I. Regulations (PICS requirements) III. Workshop case study:
concerning specifications Participants review a Operation
specification to determine
Planning
II. Content of Specifications for critical parameters
Computer Systems dealing with
• Process Specification Verification
• Packing
• Critical data
• Equipment
• Laboratory
- specifications are reviewed for
critical process parameters and
critical quality attributes

Duration: 3 hours

M Q T

Applying a Risk Based Approach to Computer Systems Validation Session 5

I. Defining the Process – What is • Examples of risk assessment
the Process to Be Validated? applied to equipment & computer
Operation
• Risk management of an example systems
process Planning
• Critical process parameters III. Testing
• Critical quality attributes • Extent and types of testing required
Specification Verification
• Requirement specifications based on risk assessment
(define "fit for use") • Commissioning and Qualification,
• Determine what to validate and the ISPE Model
the approach taken • Use of Supplier testing
• Answer the key question-Does it
need to be validated? IV. Documentation
• Supplier (Vendor) assessment • What documents do you REALLY
need?
II. Defining the Equipment and
Systems that need to be V. Workshop case study: Participants Duration: 3 hours
validated carry out a risk assessment of part
• Types of equipment and of the process M Q T
computer systems
 How to define effective Computer Systems Validation
Session 6 Test Specifications & Reports
Operation I. Regulatory Requirements for • Differentiate between critical and
Testing non-critical
Planning
• PICS requirements • Determine the risk and impact of
the exception
Specification Verification II. Testing requirements for :
• Process Control IV. Validation Reports
• Packing • How to write a summary report
• Critical data
• Equipment V. Workshop case study:
- including critical process Participants develop a test
parameters and critical quality specification or test protocol for
attributes different types of computer
III. What to Do When Things Go system
Duration: 3 hours Wrong
• Review different levels of
M Q T exceptions - test failures

Session 7 Understanding the Regulators Concern for Data Integrity

I. Introduction III. Ensure Data Integrity During
• Regulations and GMP Production Use
Operation requirements • Standard Operating Procedures
Planning • Advantages of electronic records (SOPs)
(e-records) • The role of training
• Risks to e-records, risk assessment • The role of system monitoring
Specification Verification and control • Data integrity as part of system
• The importance of data integrity retirement
• Managing e-records
• IT requirements IV. Workshop Case Study
In this activity, the attendees identify
II. Ensure Data Integrity During possible data integrity concerns for a
the Validation Process typical CAPA system.
• Data integrity as part of:
- specification
Duration: 3 hours - risk assessment
- requirements
M Q T - testing

Session 8 Incorporating Risk Management to Change Control Processes

I. Regulations and GMP • How to apply risk assessment to
Operation requirements change control
Planning • Changes to process • Examples of the use of risk
• Changes to equipment assessment for different types of
• Changes to computer systems change control and different types
Specification Verification of computer systems
II. Change Control Processes
• Procedures IV. Workshop case study:
• Types of change Participants work in groups on
different change case studies
III. Use of Risk Assessment for Computer Systems
• Risk assessment techniques and
risk management

Duration: 3 hours

M Q T