Manufacturing Computerized System and Equipment Validation

Manufacturing Computerized Systems and Equipment are, for most of them, in direct contact with the product and then traditionally exposed to inspections. Impacts of an inadequate validation could be extremely expensive as well in terms of company image as product impact. Systems being more and more complex, leveraging on developer and supplier static and dynamic tests to support IQ and OQ become crucial; but how to ensure that these developer and supplier tests will be usable and acceptable on a regulatory point of view?

 Know how to define a Validation strategy adapted to a specific situation (mono-product, multi-product, computerized or manual installation, prospective validation or not) and to the project context (supplier maturity, good practices …).

 Know regulatory and standards requirements applicable to Validation. Under-stand regulatory environment to be in compliance with requirements from EMEA and/or FDA (GMP, cGMP, GLP, GCP, QSR …).

 Know how to define and optimize Validation effort according to context and dispatch Validation activities between different Parties.

 Acquire basic knowledge to define and implement a Validation Master Plan (VMP), Validation Plan (VP), Supplier Qualification (SQ), Design Review (DR) / Design Qualification (DQ), Risk analysis (RA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Traceability Matrix.

 Know the extent of necessary techniques to successfully validate an industrial system.

 Make the difference between commiss-ioning/FAT/SAT and Validation tests and know how to leverage on Supplier tests (Integrated Validation).

 Know how to use GAMP 5 recommendations in a pragmatic manner.

Definitions and objectives of Validation.

1.2. Institutions

Presentation and description of main regulatory and standardization institutions.

1.3. Regulations, Guides and Standards

Description of requirements and proposals of European, USA and International referential: GMP, GLP, GCP, 21 CFR Part 11, BPL, BPC, ICH, GAMP, PIC/S, ISO Standards Position of officials and Inspection key points. FDA Warning Letters and/or 483’s

1.4 Basic Principles

How to justify validating installations and equipment? Independence and Critical Points Concepts.

2.Validation and Maturity

Presentation of the VMM (Validation Maturity Model). How to determine the Maturity Level of your enterprise? Impacts of the maturity on Validation projects

3. Determining Validation Strategy and Systems to validate – Validation Master Plan (VMP)

3.1. Validation Strategy

Master Validation steps, approaches, and concepts. Prospective, retrospective and concomitant Validation The main activities in Qualification / Validation Differentiate equipment validation and process validation.

3.2. Validation Master Plan (VMP)

Presentation of VMP objective and organization. Define the Qualification / Validation approach applicable to your equipment and computerized systems. How to obtain a precise, non-ambiguous and coherent VMP as well as the Validation Master List? How to manage and follow-up your systems validation status?

4. Determining Validation activities for a system or group of systems – Validation Plan (VP)

Definition and objectives of Validation Plan. Validation Plan content. How to define Validation organization, responsibilities, approach and activities in a coherent and non-ambiguous Validation Plan for each of your system or group of systems. How to determine Qualification activities to implement? Is it always necessary to perform SQ, DQ, IQ, OQ, PQ? How to justify the choices?
Practical case study: step 1/6.

5. Supplier Qualification (SQ)

Supplier Qualification definition and objectives. Key points to take into consideration; Questions not to forget; standards and references that can be used. How to use Supplier audit in an “Integrated Validation” spirit in order to facilitate the use of Supplier tests to support IQ and OQ.

6. Design Qualification (DQ)

Design Qualification definition and objectives. Presentation of main methodologies to formalize. Detail of Design Qualification allowing to prove that regulation and Good Engineering Practices have been taken into consideration during your system design and development. When and who perform Code Review? Initialization of the Traceability Matrix (from User Requirements to Design Specifications).
Practical case study: step 2/6..

7. Determining elements to qualify and test cases to implement – Risk Analysis (RA)

Risk Analysis definition and objectives. Reminder of Risk Analysis basic concepts and theory. How to define Risks? How to define a Risk Scale? How to define relevant tests from Risk Analysis outcome? Relationship between Design Review and Risk Analysis. Bring up to date the Traceability Matrix (Risk – Component / Function / Process – Test case) Presentation of CVO-RM Risk Analysis Method.
Practical case study: step 3/6..

8. Installation Qualification (IQ)

IQ definition and objectives. What is IQ and what is not IQ. Essential prerequisite for any IQ. What should we find in an IQ? When do we need to check calibration? IQ tests data sheets. Writing IQ test cases based on component Risk Analysis outcome. How to capitalize on IQ and build standardized protocols? Bring up to date the Traceability Matrix (Risk – Component – Test case)
Practical case study: step 4/6.

9. Operational Qualification (OQ)

Essential prerequisite for any OQ. Definition of OQ different types of test: Nominal, Limit (field, parameter, raw material specification limits; Worst Case; load, stress), Abnormal condition testing. OQ tests data sheets. Writing OQ test cases based on function Risk Analysis outcome. Supplier tests versus OQ tests. In which situation and with which precautions use supplier tests (commissioning, FAT, SAT)? Bring up to date the Traceability Matrix (Risk – Function – Test case)
Practical case study: step 5/6..

10. Performance Qualification (PQ)

PQ definition and objectives. PQ scope. Essential prerequisite for any PQ. The 3 phases of PQ: PQ-D – Documentation verification before release for production; PQ-S - Simulation before use with actual product; PQ-R – Routine and Reproducibility PQ tests data sheets. Writing PQ test cases based on process Risk Analysis outcome. Are 3 batches always necessary and/or sufficient? Specificities of Software PQ Bring up to date the Traceability Matrix (Risk – Process – Test case).
Practical case study: step 6/6..

11. Test execution, reports and operating

Familiarization with test execution. Documentation and evidence management. Bring up to date the Traceability Matrix (Risk – Component / Function / Process – Test case – Execution outcome – Gap). Validation Report content. Keep a system in a validated state: The success key is in Change Management: Change Control versus Change Management. Periodic evaluation versus revalidation. How to manage non-regression following change. Bring up to date the Traceability Matrix (Risk – Component / Function / Process – Test case – Change).

12. Documentation Management

How to manage validation documentation? How to implement validation templates, a document structure and an effective organization? What are the basic documentation rules which allow ensuring an adequate traceability of your project? Relations between Engineering, User and Validation documents. Reminder on Good Documentation Practices.

PRACTICAL CASE STUDY

A practical case study on one or several themes according to the number of attendants and their preferences is used all along the training session; the concerned steps are:
- 4. Validation Plan
- 6. Design Review
- 7. Risk Analysis
- 8. Installation Qualification
- 9. Operational Qualification
- 10. Performance Qualification


A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.