Change request to migrate records between two mediums

Mark Meer

Trusted Information Resource
#1
Wondering if a change record would be prudent if migrating old records between two mediums (e.g. paper-to-electronic, or from one electronic system to another)?

Technically it is a change to the system, but on the other hand, the data will be the same...
 
Elsmar Forum Sponsor
L

lokeky1

#2
Re: Change request to migrate records between two mediums?

For me, I will definitely issue a change record.

In the Pharma where I used to work, change request has a few functions
1. Risk assessment to identify potential problems and take preventive actions
2. Mode of communication
3. A record of what took place, where, when and by who.


Loke
 
S

Spazz

#3
Re: Change request to migrate records between two mediums?

I agree with lokeky1 about issuing a change request, mainly because of what you mentioned, Mark:

Technically it is a change to the system, but on the other hand, the data will be the same...
Verification checks in the change request allow you to show that the data remained the same and that there were no goofs in the data entry.
 
Thread starter Similar threads Forum Replies Date
W Part Change Request - Standard (OTS) electronic parts (resistors, capacitors etc.) IATF 16949 - Automotive Quality Systems Standard 3
J Class 1 Medical Device ECR (Engineering Change Request) Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Engineering change order versus a design change request ISO 13485:2016 - Medical Device Quality Management Systems 1
L Procedure Change Request Form - "ISO Procedures" Document Changes Document Control Systems, Procedures, Forms and Templates 5
JodiB Is DCR (Document Change Request) Needed for Initial QMS Procedures? Document Control Systems, Procedures, Forms and Templates 16
M ECN Required for Customer Labeling Change Request? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q ECR (Engineering Change Request) or NCR (Nonconformance Report) in Fabrication? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Document Change Request Flowchart - Please critique Document Control Systems, Procedures, Forms and Templates 32
N Supplier Process Change Request Procedures, Forms and Flow Charts Document Control Systems, Procedures, Forms and Templates 3
H Product Non-Conformity and Document Change Request Forms - Corrective Action needed? Nonconformance and Corrective Action 16
D Launch Change Request Form vs. Engineering Change Form Document Control Systems, Procedures, Forms and Templates 5
K Job Router - Work Instruction? - Change Request ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
P Tooling Change Request Template Document Control Systems, Procedures, Forms and Templates 2
T From ECR (Engineering Change Request) to ECN (Engineering Change Note) - double work! Document Control Systems, Procedures, Forms and Templates 2
9 ECR (Engineering Change Request) process - Please critique / review Document Control Systems, Procedures, Forms and Templates 10
H Example of DCR (document change request) form needed Document Control Systems, Procedures, Forms and Templates 14
M Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/DCO) Document Control Systems, Procedures, Forms and Templates 30
H Customer Complaint leading to Corrective Action vs. Change Request Customer Complaints 20
W Engineering ECR (Engineering Change Request) and ECN (Eng Change Notice) Procedures Document Control Systems, Procedures, Forms and Templates 3
K When to use an Engineering Change Request (ECR) Document Control Systems, Procedures, Forms and Templates 8
J Looking for examples of "Temporary Change Request" form Document Control Systems, Procedures, Forms and Templates 2
O ECN (Engineering Change Notice) to ECR (Change Request) Database with Email Report Document Control Systems, Procedures, Forms and Templates 8
U Advice on Engineering Change Request (ECR) software Software Quality Assurance 4
F Changing material without a granted change request, ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
sardonyx ECR (Engineering Change Request) Flowchart - Is this a work instruction Document Control Systems, Procedures, Forms and Templates 9
H Formats for Master List of Quality Records (MQR) & Document Change Request Form (DCR) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Engineering Change Request (ECR) / Notice (ECN) - Seeking Example Forms Document Control Systems, Procedures, Forms and Templates 21
M Customer Requirements - Request customer change their drawing to match the dimension ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
qualprod What do CB´s change when doing a partial moving ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Y Algo change significancy Medical Information Technology, Medical Software and Health Informatics 0
Revision36 Engineering Change Order Industry Standards Other Medical Device and Orthopedic Related Topics 4
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 2
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
Q Change the shape of the raw material FAI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Engineering Change Order (ECO) metrics to track ISO 13485:2016 - Medical Device Quality Management Systems 6
P Notified Body Approval of Change EU Medical Device Regulations 2
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
J FDA notification of address change US Food and Drug Administration (FDA) 2
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3

Similar threads

Top Bottom