CSV - Periodic Review

D

devin

Registered
#1
#1
As part of periodic review, assimilating the changes done in the system since initial validation.
1. System server and DB has been changed, does this require re-execution of IQ or only Design specification update?
2. If none of the system changes are functional, with no risk on daily operations/usage, it does not have any impact on the validated state of the system. Is this a correct statement?
3. The work Instruction/manual for system users is not a formal approved document. Is this a deviation to be recorded in periodic review?
 
Download Free White Paper
Elsmar Forum Sponsor
Y

yodon

Leader
Super Moderator
#2
#2
For now, let's consider this one:

devin said:
2. If none of the system changes are functional, with no risk on daily operations/usage, it does not have any impact on the validated state of the system.
Click to expand...
What evidence do you have to make those assertions?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
V Quality agreement for CSV service provider Qualification and Validation (including 21 CFR Part 11) 2
V Csv, excel format - audit trail file of HPLC system ( Empower, openlab, EZchrom or any other ) Qualification and Validation (including 21 CFR Part 11) 0
R IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B Zeiss CMM Calypso output to Excel or CSV file Help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 17
L Importing CSV (comma separated values) / Excel process steps into Visio diagram Excel .xls Spreadsheet Templates and Tools 2
V Exemption of s/w applications from CSV/part 11 compliance Qualification and Validation (including 21 CFR Part 11) 2
V "Value" and "Overhead(s)" of implementation of "CSV - Validation requirements" Qualification and Validation (including 21 CFR Part 11) 1
Kales Veggie Report Writer for Excel spreadsheet or CSV (Comma-Separated Values) Format Excel .xls Spreadsheet Templates and Tools 8
J Periodic review of Documents during management review Document Control Systems, Procedures, Forms and Templates 26
V Process revalidation periodic criteria Manufacturing and Related Processes 5
P 21 CFR 58 GLP Periodic Study Phase Inspection Report Other US Medical Device Regulations 0
V Is periodic-requalification relevant for laboratory instruments Qualification and Validation (including 21 CFR Part 11) 1
A TGA - Annual Report or Periodic Safety Update Report? Other Medical Device Regulations World-Wide 0
B SAP Audit trail Periodic Review EU Medical Device Regulations 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
Marc Interesting Discussion The periodic table is 150 years old - March 2019 Coffee Break and Water Cooler Discussions 3
P Periodic Review - Deviations/incidents that are reviewed Qualification and Validation (including 21 CFR Part 11) 8
M FDA or CE requirements for periodic checks of data backups and retrievals EU Medical Device Regulations 4
T Regulation (EU) 2017/745 and PSUR (periodic safety update report) EU Medical Device Regulations 9
V Periodic review criteria for reviewing/updating SOPs US Food and Drug Administration (FDA) 1
P EU MDR and PSUR (Periodic Safety Update Report) EU Medical Device Regulations 46
V Periodic Audit Trail Review - Scope, Content & Frequency Qualification and Validation (including 21 CFR Part 11) 13
B IATF 16949 Cl. 8.5.1.5 - Requirement for Periodic Overhaul IATF 16949 - Automotive Quality Systems Standard 10
S How to document revisions after Periodic Review of documents ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
I Does ISO 13485 have a Periodic Document Review Requirement? ISO 13485:2016 - Medical Device Quality Management Systems 7
A Current Control Periodic Document Reviews - Process Updates in the FMEA FMEA and Control Plans 3
F Periodic Review Requirements for Software - Medical DeviceS Software Quality Assurance 2
T Periodic Quality Manual and Procedure Review Requirements General Auditing Discussions 5
S Is hiring a CB for certification and periodic audits an outsourced activity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
V Where & How to Capture Details of Periodic Reviews of Change Control & CAPAs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
T Clause for Maintenance - Periodic Maintenance Activity (Oil change) Internal Auditing 4
C API Q1/ISO-TS 29001 Periodic Assessment of Stock Oil and Gas Industry Standards and Regulations 3
S Auditing our own activity - Periodic audit of our documentation Internal Auditing 11
B Can I Claim That Periodic Calibration is Not Required? ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Computerized System Periodic Review Requirement - Pharma Company Qualification and Validation (including 21 CFR Part 11) 7
R Periodic evaluation of suppliers - ISO 17025 4.6 Purchasing services and supplies ISO 17025 related Discussions 3
R Do Engineering Standards require periodic review? ISO 9001 4.2.4 (b) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
M Documents of External Origin - Periodic or annual verification of revision status ISO 13485:2016 - Medical Device Quality Management Systems 10
M Surface plates - Questioning the need for periodic calibration of surface plates General Measurement Device and Calibration Topics 12
I Periodic Review of Process and Equipment Validation Qualification and Validation (including 21 CFR Part 11) 4
R Periodic / Maintenance Audits Schedule ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Periodic Product Requalification Process IATF 16949 - Automotive Quality Systems Standard 1
tony wardle Periodic Evaluation of Legal Compliance - ISO 14001 - 4.5.2.1 - Legal Requirements ISO 14001:2015 Specific Discussions 22
K Periodic validation of raw material test reports (7.4.3) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
K Review complete, no changes needed - When a Procedure is due for a periodic review? Document Control Systems, Procedures, Forms and Templates 10
T QP-5.6.0 - Management Review should be both periodic and continual Management Review Meetings and related Processes 14
S ISO 14001 - Periodic External Audit by Consultant Requirement? ISO 14001:2015 Specific Discussions 99
A Meeting the ISO 14001 Periodic Audits Requirement - Internal vs. External Auditing ISO 14001:2015 Specific Discussions 11
D ISO 9004 6.2.2.2 has listed "periodic refresher programs for people already trained" General Auditing Discussions 6
M What does the APQP manual mean by the term 'Periodic Requirements' FMEA and Control Plans 2

Similar threads

Top Bottom