Validation Deliverables
Understanding & Meaning
Start
ContenT
The supplier & user have different tasks to perform with regard to the validation and implementation of an alternative method. These tasks are summarised in different table depend of regulation :
Risk Assessment
Qualification
Validation Plan
URS Completion Guide
Validation
SOP
Primary Validation Report
- Table 5.2-1 for PDA
- Table 5.1.6.-1 in Ph. Eur.
Resume
Inventory
Vocabulary
URS Completion Guide : all-in-one document with 3 parts:
FDS
URS
RTM
AIM: Provide traceability that all the requirements listed in the FDS and URS have been verified and tested STAKES: Know and understand which requirement is tested in the Qualificationof the system.
AIM: Describe context and intented use of the product by the customer. STAKES: Know and understand the customer:
- Its Regulatory framework.
- Its Validation requirements.
- Its Operational conditions (end-use, IT).
- Its analysis method
AIM: Describe the system capabilities. STAKES: Know and understand the system.
- Technical Functions.
- Data management
- Analysis performance.
- Operational conditions.
- Use restrictions
+ INFO
+ INFO
+ INFO
RISK ASSESSMENT
PATIENT Risk Analysis
/ CAREFUL/ This PATIENT risk assessement is different from the project risk analysis. /
Stakes:
Fine tune the validation effort during all the product lifecycle.
- For the system
- For the analysis method.
Should I do ..
--> New method validation ?
--> Only suitability tests ?
Aim:
Identify the patient risks due to how the system and the analysis method are used.
+ INFO
VALIDATION PLAN
AIM
STAKES
Describe the organisation of all the validation activities.
Explain the overview of the validation strategy to the authorities.
+ INFO
Qualification
Term used only for the system
Aim: Establish documented evidence that control means are in place and effective. Stakes: Trusting the end-user that there will be no pharmaceutical breaches when using the system.
DQ
IQ
oQ
+ INFO
PQ
REQUALIFICATION
DECOMMISSIONING
VALIDATION
Method Validation
Suitability Testing
To verify that the analytical method gives the expected results ON PURE CULTURES.
To verify that THE FINAL PRODUCTS ARE COMPATIBLE with the analytical method
for execution
+ INFO
+ INFO
/ BONUS / Internal data could be summarized in a report: PRIMARY VALIDATION REPORT
+ INFO
Primary Validation ReporT (PVR)
Method Validation Criteria
The PVR wasn't in regulation guide, but is also important document that bMx creates and usually added to Customer MV package. Eight (8) first criteria could be included in this PVR.
Equivalence must be done with the customer product
+ INFO
Recommended organisms:
Standard Operating Procedures
SOP
Offer
Stakes
Aim
Currently not cover in the bioMérieux offer. To cover SOP needs, bMx provides User Manuals
All users adhere to the same process.
Make sure that end-users can understand :
- How to use the system & the method
- The administration of the system.
+ INFO
VOCABULARY
Wording modification
Your company name
From now on, we cleary distinguish 2 mains steps:
- FIRST STEP : QUALIFICATION of a system
- SECOND STEP : VALIDATION of a method
Lorem ipsum dolor sit amet, adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna erat aliquam erat volutpat.
The terms PQ1 and PQ2 must not be used anymore in our vocabulary. The term “PQ” relates now exclusively to system qualification.
+ INFO
+ INFO
INVENTORY
21 CFR part 11
GAMP
CSN
Assessment
4793 & 2022-47
5059 /
2022-145
2022-016
5242
/ 2023-320
4969
2022-015
5232
/ 2023-319
tbd
5233
/ 2023-391
/ 2023-451
5514
Resume
Validation Plan
URS
FDS
PQ
SOP
MV / PVR
MST
URS Completion Guide
RTM
RA
OQ
Services proposed by bioMérieux:
Documentation available
Service execution possible
Neither doc. or execution
Accountability:
Customer
Supplier
depending on country capacity
IQ
DQ
SYSTEM INTEGRATION
Validation Deliverables
Biomerieux
Created on December 17, 2021
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Transcript
Validation Deliverables
Understanding & Meaning
Start
ContenT
The supplier & user have different tasks to perform with regard to the validation and implementation of an alternative method. These tasks are summarised in different table depend of regulation :
Risk Assessment
Qualification
Validation Plan
URS Completion Guide
Validation
SOP
Primary Validation Report
Resume
Inventory
Vocabulary
URS Completion Guide : all-in-one document with 3 parts:
FDS
URS
RTM
AIM: Provide traceability that all the requirements listed in the FDS and URS have been verified and tested STAKES: Know and understand which requirement is tested in the Qualificationof the system.
AIM: Describe context and intented use of the product by the customer. STAKES: Know and understand the customer:
AIM: Describe the system capabilities. STAKES: Know and understand the system.
+ INFO
+ INFO
+ INFO
RISK ASSESSMENT
PATIENT Risk Analysis
/ CAREFUL/ This PATIENT risk assessement is different from the project risk analysis. /
Stakes: Fine tune the validation effort during all the product lifecycle.
- For the system
- For the analysis method.
Should I do .. --> New method validation ? --> Only suitability tests ?Aim: Identify the patient risks due to how the system and the analysis method are used.
+ INFO
VALIDATION PLAN
AIM
STAKES
Describe the organisation of all the validation activities.
Explain the overview of the validation strategy to the authorities.
+ INFO
Qualification
Term used only for the system
Aim: Establish documented evidence that control means are in place and effective. Stakes: Trusting the end-user that there will be no pharmaceutical breaches when using the system.
DQ
IQ
oQ
+ INFO
PQ
REQUALIFICATION
DECOMMISSIONING
VALIDATION
Method Validation
Suitability Testing
To verify that the analytical method gives the expected results ON PURE CULTURES.
To verify that THE FINAL PRODUCTS ARE COMPATIBLE with the analytical method
for execution
+ INFO
+ INFO
/ BONUS / Internal data could be summarized in a report: PRIMARY VALIDATION REPORT
+ INFO
Primary Validation ReporT (PVR)
Method Validation Criteria
The PVR wasn't in regulation guide, but is also important document that bMx creates and usually added to Customer MV package. Eight (8) first criteria could be included in this PVR.
Equivalence must be done with the customer product
+ INFO
Recommended organisms:
Standard Operating Procedures
SOP
Offer
Stakes
Aim
Currently not cover in the bioMérieux offer. To cover SOP needs, bMx provides User Manuals
All users adhere to the same process.
Make sure that end-users can understand :
+ INFO
VOCABULARY
Wording modification
Your company name
From now on, we cleary distinguish 2 mains steps:
Lorem ipsum dolor sit amet, adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna erat aliquam erat volutpat.
The terms PQ1 and PQ2 must not be used anymore in our vocabulary. The term “PQ” relates now exclusively to system qualification.
+ INFO
+ INFO
INVENTORY
21 CFR part 11
GAMP
CSN
Assessment
4793 & 2022-47
5059 /
2022-145
2022-016
5242
/ 2023-320
4969
2022-015
5232
/ 2023-319
tbd
5233
/ 2023-391
/ 2023-451
5514
Resume
Validation Plan
URS
FDS
PQ
SOP
MV / PVR
MST
URS Completion Guide
RTM
RA
OQ
Services proposed by bioMérieux:
Documentation available
Service execution possible
Neither doc. or execution
Accountability:
Customer
Supplier
depending on country capacity
IQ
DQ
SYSTEM INTEGRATION