Document and Data Changes

V

Vash Stampede

#1
On Item # 5.3 Document and Data Changes:
Changes to documents and data will be reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise. The designated functions/organizations will have access to pertinent background information upon which to base their review and approval.
Where applicable, the nature of the change shall be identified in the document or the appropriate attachment.
1. Is it referring that for example, "I came from engineering department, whenever I made changes on the document, I shall be issuing an ECN (Engineering Change Notice), then it shall be approved (all department heads) and not within the same organization, 2. Am I not violating this item 5.3? Please comment. 3. Does it mean 'within the same organization/function' >>>>within the same department? PLease advice.
Thanks,
Vash Stampede
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
> Changes to documents and data will be reviewed and approved by the same
> functions/organizations that performed the original review and approval,
> unless specifically designated otherwise.

To put it simply, if you are responsible for it (you wrote it) it's yours. Adding other reviews and or approvals from other people and/or departments is not a problem as long as the responsible person/department also reviews it. Typically the 'ultimate' approval is the province of the responsible person/department.

Have I confused the issue or does this answer your question?

[This message has been edited by Marc Smith (edited 19 December 2000).]
 
Thread starter Similar threads Forum Replies Date
I Data Backup Plan - Document Reference ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q MHRA has released a new guidance document related to 'GXP' Data Integrity EU Medical Device Regulations 3
R Wet Signature Document Attachments in SAP - Risk on Data Integrity issue? Records and Data - Quality, Legal and Other Evidence 6
C AS9100 C Requirement for a Document and Data Control Table AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
K Document and Data Control Stamps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L Data Management and Web based Document Control Software Document Control Systems, Procedures, Forms and Templates 18
S Special 510k for Data Management Software Document Requirements IEC 62304 - Medical Device Software Life Cycle Processes 1
Q Control of MSDS (Material Safety Data Sheets) - Document Control required? Miscellaneous Environmental Standards and EMS Related Discussions 8
I Summary Technical Document (STED) and OEM Technical data ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 9001:2000 - 4.2.3 Control of Documents - Used to be document and data control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
H Does Powerway's APQP - PPAP fulfill TS16949 document and data control requirements? Customer and Company Specific Requirements 2
C ISO 14001 Document and Data Control Corrective Action Request Miscellaneous Environmental Standards and EMS Related Discussions 31
H Document and Data Control Insight Document Control Systems, Procedures, Forms and Templates 4
H Document and Data Control Section of a Quality Manual Quality Management System (QMS) Manuals 4
H Document and Data Flow Chart Help Needed Other ISO and International Standards and European Regulations 16
A Document and Data Control - We are not satisfied with electronic document security Other ISO and International Standards and European Regulations 3
M Document Architecture ISO 13485:2016 - Medical Device Quality Management Systems 2
cgaro62 Using internal audits as part of document reviews Document Control Systems, Procedures, Forms and Templates 21
J Training on the importance of Document Control Document Control Systems, Procedures, Forms and Templates 3
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
H Document retention period Canada Medical Device Regulations 2
S Document Notes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
Ed Panek MR Mandate Document EU Medical Device Regulations 1
C Document Index Document Control Systems, Procedures, Forms and Templates 5
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
B Document Issued with incorrect Document number code Document Control Systems, Procedures, Forms and Templates 3
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 13
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
J UDI - Where to document it? EU Medical Device Regulations 8
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
S Changing revision status of a reviewed document Manufacturing and Related Processes 11
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 4
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Document ownerships Document Control Systems, Procedures, Forms and Templates 15
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 9
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
M What is the proper way to document measurements Measurement Uncertainty (MU) 1
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom