Do Memos have to be under Version (Document or Record) Control?

Elsmar Forum Sponsor
U

Umang Vidyarthi

#2
Re: memos

What do you mean by 'version control'? Is your question about internal memos or external?

Umang :D
 

qusys

Trusted Information Resource
#3
Re: memos

Hi,
Do memos have to be under version control?
It depends on what your procedure for documents control says and establishes. So, it is up to you . However it is fundamental to respond to the clauese of that part of ISO standard :bigwave:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Re: memos

I would venture to say that the content of the memo and its purpose would also be a factor.
 
#5
Re: Do memos have to be under version control?

Hi,
Do memos have to be under version control?
It depends what 'memos' are used for, in the lab...tell us more. We really can't give you much of a reply without some more information from you about this.
 
M

MIREGMGR

#6
Re: Do memos have to be under version control?

If the subject of the memo is "please don't wear shorts and flip-flops next Tuesday--the bankers are coming in to meet with us", that one (probably) doesn't need version control.

If on the other hand it's a memo-to-file discussing how you reconcile the FDA's requirement for English text on labels with the EC's preference for standardized symbols and mandate that most text be translated into 28 languages, then yes, the memo has regulatory significance and should be version controlled.
 
S

samsung

#7
Re: Do memos have to be under version control?

If the subject of the memo is "please don't wear shorts and flip-flops next Tuesday--the bankers are coming in to meet with us", that one (probably) doesn't need version control.

If on the other hand it's a memo-to-file discussing how you reconcile the FDA's requirement for English text on labels with the EC's preference for standardized symbols and mandate that most text be translated into 28 languages, then yes, the memo has regulatory significance and should be version controlled.
A memo is a sort of record (minutes) and I'm not convinced if it requires a version control. Any record is a history that can have only one version, e.g. minutes of a meeting. How & why should it be changed to cause a change in it's previous version? Or if one likes to treat it as a 'document', why should it then be called as a 'memo' at all?

I don't deny that these shouldn't be controlled. They must be but in the same way as other xMS RECORDS are controlled w.r.t. their "identification,
storage, accessibility, protection, retrieval, retention and disposition".
 
M

MIREGMGR

#8
Re: Do memos have to be under version control?

"Memo to File" is traditional terminology in US FDA regulatory compliance, to refer to a record of a determination of one's forward-going regulatory position or stance in a circumstance where rules and guidances are incomplete, imperfectly applicable or conflicting.

A Memo to File provides substantiation in a later audit/inspection circumstance that difficult decisions and actions have been based on a compliance rationale rather than a lack of compliance effort.
 
S

samsung

#9
Re: Do memos have to be under version control?

"Memo to File" is traditional terminology in US FDA regulatory compliance, to refer to a record of a determination of one's forward-going regulatory position or stance in a circumstance where rules and guidances are incomplete, imperfectly applicable or conflicting.

A Memo to File provides substantiation in a later audit/inspection circumstance that difficult decisions and actions have been based on a compliance rationale rather than a lack of compliance effort.
The 'memo' you referred to here is a specific legal terminology given to a method of recording some critical information for one's own defense so that it can be used to protect oneself (usually in a court of law) if the situation turns out to be against him, e.g. a doctor may write a 'memo to file' if the patient declined the course of treatment he prescribed to the patient or a lawyer might note a 'memo to file' for the legal advice which his client chose to decline to.

Aren't these records of what happened at a point of time in past? Does it need to have a version control as the traditional 'document' do? As I already said, these can be controlled but only in accordance with 4.2.4. Further, IMO, what OP is asking is probably about the 'conventional office memos' used to communicate (pass on) some kind of information within the organization, to another person/ group or to customers/ suppliers / contractors etc.
 
Last edited by a moderator:
M

MIREGMGR

#10
Re: Do memos have to be under version control?

A doctor's memo to file pertains to a single event. Probably many other types of businesses have a similar requirement.

Our manufacturing, on the other hand, tends to be a stream of batches. Our legal and regulatory stances sometimes change because we learn something about how the product behaves or is used. Or, there might be a running design change or materials change, with regulatory or legal implications. Or whatever.

To address those kinds of changes, we need to track when (date and batch number) our stance was X, and when it changed to Y.

Thus, versioning of our regulatory files, including memos to file.
 
Thread starter Similar threads Forum Replies Date
V Memos - Nonconformance as illegal posting of work instruction Document Control Systems, Procedures, Forms and Templates 15
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 1
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
J Reusable surgical Instrument is under class IIa? EU Medical Device Regulations 4
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
F Plastics cans shelf life determination under static load Manufacturing and Related Processes 1
L Classification under MDR EU Medical Device Regulations 1
K Biological indicator system classification under MDR EU Medical Device Regulations 2
K Advertising and promotion of device under investigation China Medical Device Regulations 1
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 3
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
H Incomplete IVD kit under IVD Regulation EU Medical Device Regulations 1
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 2
F Is there such a thing as 'Critical supplier' status under the Dept. of Health (UK)? Medical Device and FDA Regulations and Standards News 2
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
T API Q1 - Will I be able to maintain Q1 if I have products that fall under 6A Oil and Gas Industry Standards and Regulations 5
W Issuing reports under ISO 17025:2017 ISO 17025 related Discussions 2
JoCam Software Translation under MDR requirements EU Medical Device Regulations 5
M MDR - Under what circumstances is a PMCF not required? EU Medical Device Regulations 1
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 11
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
R Breast Pump under MDR classified as medical device? EU Medical Device Regulations 9
E Under MDR is a medical workstation a medical device or an accessory? EU Medical Device Regulations 5
E Can we still use MEDDEV 2.4/1 rev. 9 when classifying a medical device product under MDR? EU Medical Device Regulations 4
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
C Sterility and Bioburden Testing - LAL passed under 0.5EU/mL Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
A EAR costs and recommendations under MDR CE Marking (Conformité Européene) / CB Scheme 0
M Informational EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational EU – New notified body designated under the MDR – NB 1912 – DARE!! Services B.V. – Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational Is my device a Reusable Surgical Instrument under the EU MDR(2017/745)? Medical Device and FDA Regulations and Standards News 0
B Accredited laboratory or not under MDD 93/42/EEC IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
M Informational BSI UK notified under the IVDR Medical Device and FDA Regulations and Standards News 2
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3

Similar threads

Top Bottom