SOP unification. Revision No, Revision history

#1
Hello,

I am currently reorganising the content of the SOPs of the Pharmacovigilance system. As a result, I have unified some SOPs, therefore document coding has changed. My dilemma is, do I write that the new reviewed SOP is introduced for the first time (hence Version 1) since it has a different code and contains information from multiple SOPs, or do I write Version 2 and mention the codes/titles of the SOPs that were unified.

Thank you!

Regards,
Cristina
 
Elsmar Forum Sponsor

Richard Regalado

Trusted Information Resource
#2
Hello Cristina.

I can do it 2 ways.

1. A brand new document, hence version 1. But with a section/preface/footnote containing a short description on how the other SOPs were merged to create the brand new document.

2. I will choose the document that contains the most content of all the other SOPs and will iterate the revision number of that document. In the revision history, I will make mention that this revision is a conglomeration of other SOPs.

Let me know your course of action.
Cheers!
 
#3
1. A brand new document, hence version 1. But with a section/preface/footnote containing a short description on how the other SOPs were merged to create the brand new document.

2. I will choose the document that contains the most content of all the other SOPs and will iterate the revision number of that document. In the revision history, I will make mention that this revision is a conglomeration of other SOPs.

Thank you, Richard.

I believe both suggestions may work for me to some extent. The confusion is because I have the following situation:

- I merge SOP 1, 2, 3 under SOP 1 Version 2 (as you mentioned in 2)
- I merge SOP 4, 5 under SOP 2 Version 1, because of the shifting in the document coding having a note mentioning how the documents fused
- I have a totally new SOP, which I code under SOP 3 Version 1 (do I mention here that the old SOP 3 was withdrawn and that the new SOP 3 contains totally different information?)

Thank you for your reply
 

Richard Regalado

Trusted Information Resource
#4
Thank you, Richard.

I believe both suggestions may work for me to some extent. The confusion is because I have the following situation:

- I merge SOP 1, 2, 3 under SOP 1 Version 2 (as you mentioned in 2)
- I merge SOP 4, 5 under SOP 2 Version 1, because of the shifting in the document coding having a note mentioning how the documents fused
- I have a totally new SOP, which I code under SOP 3 Version 1 (do I mention here that the old SOP 3 was withdrawn and that the new SOP 3 contains totally different information?)

Thank you for your reply
Hello Cristina.

I suggest the following:

- Do not use the name SOP2 since it was already used (now merged into something else). Put a note somewhere that SOP 2 and SOP 3 are merged into SOP 1.
- For the merged SOP 4 and 5, you may use either SOP 4 or SOP 5 as the name
- The new document will be SOP 6.

This is how I will do it. I will not re-use the names/codes of withdrawn, or merged documents.

BUT, this is not in the Standard. So as long as we identify our document, we are good.

Let me know if I made sense, or confused you some more. LOL.

Regards,
 
Thread starter Similar threads Forum Replies Date
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
N Agile SOP for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 8
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
B How to apply external voltage to SIP/SOP IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Software SOP - Use and maintenance of an ERP system Software Quality Assurance 4
M What to do in SOP Phase of Head unit testing? IATF 16949 - Automotive Quality Systems Standard 0
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
W SOP examples wanted - Soil, Concrete and Asphalt testing ISO 17025 related Discussions 3
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 0
M SOP Sample for BC/ISO22301 (Business Continuity) wanted Business Continuity & Resiliency Planning (BCRP) 4
M Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind EU Medical Device Regulations 10
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 4
V Protocol, report or SOP for threshold analysis? Human Factors and Ergonomics in Engineering 0
V Nature of references allowed to be cited in the SOP US Food and Drug Administration (FDA) 2
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 3
M Charging consulting fees for SOP development and guidance Document Control Systems, Procedures, Forms and Templates 13
J Just Venting - Do you refer directly to MDR or you just refer to SOP's? CE Marking (Conformité Européene) / CB Scheme 3
E CSR SHIPPING - Need suggestions for making SOP/WI for our shipping dept (automotive)... Customer and Company Specific Requirements 11
S Should there be a SOP on Cybersecurity? ISO 14971 - Medical Device Risk Management 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
J Nonconforming product procedures SOP help :) Nonconformance and Corrective Action 2
G NIST SOP 29 - Assignment of Uncertainty - Question General Measurement Device and Calibration Topics 0
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
S SOP Training/Competence in 24/7 Operation contractor company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Video under Document Control SOP ISO 13485:2016 - Medical Device Quality Management Systems 2
J Business Impact Analysis SOP Business Continuity & Resiliency Planning (BCRP) 2
Jane's Do you have an SOP for communicating with regulatory authorities ISO 13485:2016 - Medical Device Quality Management Systems 8
D 21 CFR Part 11 - Electronic Signature Management SOP Other US Medical Device Regulations 0
A AQL Sampling Plan SOP / WI - Medical Device Industry Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
S Authorized (EC) Representative Contract and SOP EU Medical Device Regulations 12
M SOP or template for a study to Define Storage Conditions of Orthopaedic Implants EU Medical Device Regulations 3
J Does anyone have an example Authority Listing SOP example? Misc. Quality Assurance and Business Systems Related Topics 3
S Clinical evaluation standard operating procedure / SOP for medical devices Document Control Systems, Procedures, Forms and Templates 1
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Document Control Systems, Procedures, Forms and Templates 11
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1
S Post Market Surveillance procedure/ SOP Medical devices Imported Legacy Blogs 0
C Regulatory Authority Communication SOP ISO 13485:2016 - Medical Device Quality Management Systems 6
J Training SOP and Forms Training - Internal, External, Online and Distance Learning 3
R Review of "Key Data" for contract labs, but SOP doesn't define "key data". Problem? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
S Medical Device Reporting SOP (Standard operating procedure) example Other Medical Device and Orthopedic Related Topics 1
G SOP or Work Instruction for PFMEA? FMEA and Control Plans 5
R Supplier Process Review and Issue Communication SOP/Form help wanted Supplier Quality Assurance and other Supplier Issues 4
F SIP/SOP - Mains Power and Medical Device Ethernet Ports IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
Similar threads


















































Top Bottom