Changing a Form Template & Updating Records

A

adubu

#1
Good morning. I've got a unique situation. When our manuals were written, the form templates included the manual issue # & manual issue effective date in the header. Consequently, each record has "Manual Issue: 2" on the hard copy, and now the Manual Issue is #3.

I've eliminated the manual issue # & date from the forms header in the latest form version, but is it okay to go back and put the old record data (unchanged) into the new form, so that they're not tied with an actual manual issue # ?

Thanks in advance.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Are your referring to records which were made when manual 2 was in place?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Let the records remain as they are. They're old records and were made under the manual 2 form. It doesn't matter that they are "tied" to an old manual. It would be wise to have an archived manual 2, though.

Rule of thumb is never revise data/records.

Somewhat related: Modifying an old printed record
 
A

adubu

#5
Thank you for your advice.

What if I'd like to include those records in manual #3? #3 would be pretty bare without those records.

I suppose I need to research proper filing techniques for archived records with regard to our hard-copy manual (binder).

Any suggestions on how to file them for archival purposes in issue #3 binder? Perhaps just a section for "archived records"?

Thanks again for your help. I can't tell you how appreciative I am of having a little guidance.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
What is the manual you are referring to? A quality systems manual?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
Your system should be set up so that your quality systems manual is separate from records. Adding records to a manual is something I have never seen done.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Thank you for your advice.

What if I'd like to include those records in manual #3? #3 would be pretty bare without those records.
Each should have their own binder.

I suppose I need to research proper filing techniques for archived records with regard to our hard-copy manual (binder).
Just file them in a filing cabinet.

Any suggestions on how to file them for archival purposes in issue #3 binder? Perhaps just a section for "archived records"?
That sounds like a duplication of the records. Just file the old records in a binder and store it in a file cabinet or book shelf.

Don't over complicate things. Each is a separate thing and typically should be kept separate.
 
A

adubu

#10
Thanks for the info. Ours was done with the procedures manual, form templates and Records in the same binder, albeit, subdivided into sections. I assume it'd be good to separate as you said.
 
Thread starter Similar threads Forum Replies Date
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
D Clothes changing in pharmaceutical factory Manufacturing and Related Processes 8
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T AS9100 - Changing PEARs target AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
A IMDS - Changing the Locked Weight Value RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
P Romer Arm - Profile of a Surface Changing General Measurement Device and Calibration Topics 4
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
L MINITAB 17 - Changing Data Using Minitab Software 3
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Changing Registrars Registrars and Notified Bodies 15
MDD_QNA Changing the Layout of Medical Device Label(s) CE Marking (Conformité Européene) / CB Scheme 3
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
J Changing of our New Hire Orientation Training Records Training - Internal, External, Online and Distance Learning 12
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
shimonv Changing the Label of a Medical Device product in the field Other US Medical Device Regulations 5
E Information required about changing an off shelf part 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WCHorn Changing Sampling Accept Number to Zero, Arbitrarily AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
S Gage R&R on Potentially Changing Parts - Guidance Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
R Changing CE Mark on Documentation ISO 13485:2016 - Medical Device Quality Management Systems 2
K Changing the Auditor within a Notified Body ISO 13485:2016 - Medical Device Quality Management Systems 4
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 6
M Changing Notified Body - Anyone have stories to share CE Marking (Conformité Européene) / CB Scheme 3
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4
W Depth Gage Spindle moved when changing Contact Point Calibration and Metrology Software and Hardware 6
M Changing a Chinese Legal Agent China Medical Device Regulations 5
B Changing dimensional tolerances to approve rejected product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Change Control Requirements when changing Suppliers IATF 16949 - Automotive Quality Systems Standard 4
P Changing from contract manufactured to self manufactured 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Document Control - Changing Company Logo Document Control Systems, Procedures, Forms and Templates 10
L Changing Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
P Changing the Trade Name of a cleared Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom