Electronic Copies of previous versions of Controlled Documents in editable format

B

bonnieblue

#1
hello covers,

happy halloween to everyone!

i just had a question pop into my head as i am doing some cleanup of our system leftover from the previous system owner. a year in and i'm still doing cleanup!

do you keep electronic copies of previous versions of controlled documents in editable format? in my system, because we don't have an e-sig or e-doc mgmt system, i publish docs in pdf and keep an editable version for when we move to the next version.

the next part of this question is if we keep paper copies of previous versions of controlled docs, do we even need to keep previous electronic versions?

we are in the animal pharma world.

thanks in advance!
 
Last edited by a moderator:
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hi Bonnie,

The answer is, as so often is the case, a maddingly vague it depends.

In regulated industries like pharma, I wouldn't dream of keeping old copies in editable versions. In animal pharma I would think the protocol would be somewhat more relaxed than human pharma.

To answer the "why" question to the above, we look to the "it depends" factors.

The risk of having edited versions of old documents. This involves information loss, corruption, and/or tampering. The risk is in losing historical integrity. The consequence is whatever results, and the driver is the risk of someone, or something causing the information to be altered.

For this reason, an electronic storage could be set up using software that doesn't allow a document to be restored with changes. Paper copies could do the same thing. The FDA requires (I doubt you are required to go this far) that hand written records and test results are kept on file, probably to help assure the data's validity.

Neither document retention approach is fool proof, and both can suffice if done completely, safely and as planned.
 
Likes: db
#3
Probably the easiest way, and cheapest way to prevent old documents from being edited is to set them as "read only" and password protect them. Also, keep them in a separate file location that is not as easy to get to as the active revision. You can also password protect the folder through sharing.
 

jkuil

Quite Involved in Discussions
#4
Your regulations will provide rules for record retention. During the retention period you need to have a readable copy of your documents. That copy should demonstrate that it was an authorised and released version of the document (demonstratable through the required signatures). Through this copy you can demonstrate what quality system was applied to your product at the time it was manufactured. Frequently, in batch records there is a reference to which workinstruction was applied. If that WI is not available throughout the retention period of the batch record, you can not demonstrate the full quality of your product.

The copy does not need to be editable, preferably not, because this increases the risk of unauthorised changes. The controlled copy must be protected against any change once a signature is applied to it. Basically similar to paper records.
 
Thread starter Similar threads Forum Replies Date
M Original written signatures vs. Copies/scans/faxes/electronic documents US Food and Drug Administration (FDA) 24
B Controlled Copies of a Quality Manual in an electronic media (file/server) Quality Management System (QMS) Manuals 9
Q AIAG Manuals - Where to purchase electronic copies of AIAG Manuals APQP and PPAP 3
K Customer has requested electronic copies of our SOPs and WIs Document Control Systems, Procedures, Forms and Templates 4
Q Should electronic copies of Procedures show the approval signatures? Document Control Systems, Procedures, Forms and Templates 5
Marc Hard Copies from Electronic Media Document Control Systems, Procedures, Forms and Templates 1
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 3
Q From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J Integrity of electronic digital records - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
T Electronic ECO/ECR Process - Software recommendations Document Control Systems, Procedures, Forms and Templates 3
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
D Benefits of electronic QMS software Software Quality Assurance 5
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
R Electronic handwritten signatures for approvals - Signed with a Stylus or a Finger Document Control Systems, Procedures, Forms and Templates 2
WEAVER Electronic Weighing Scale Calibration Tolerance Manufacturing and Related Processes 1
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
P FDA inspections and electronic signatures Other US Medical Device Regulations 2
S Need Assistance in Visual Inspection - Tiny electronic components AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
G Looking to move to an electronic QMS software Software Quality Assurance 10
QIE Electronic IFU - new project, need input Other Medical Device and Orthopedic Related Topics 0
U Electronic templates for making paper control charts Reliability Analysis - Predictions, Testing and Standards 2
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
P Electronic component failure analysis turnaround time Reliability Analysis - Predictions, Testing and Standards 0
W Part Change Request - Standard (OTS) electronic parts (resistors, capacitors etc.) IATF 16949 - Automotive Quality Systems Standard 3
C In cases where users of an electronic system change their names Qualification and Validation (including 21 CFR Part 11) 6
A How a test flow can be build for a car electronic sunroof control Reliability Analysis - Predictions, Testing and Standards 6
M Electronic signature - name.lastname or equal to handwritten Document Control Systems, Procedures, Forms and Templates 3
N Electronic Instructions for use (eIFU) EU Medical Device Regulations 1
M Electronic Signature - Certificate Qualification and Validation (including 21 CFR Part 11) 8
I GMP 21 CFR Part 11 Electronic Records Compliance Project Help Qualification and Validation (including 21 CFR Part 11) 9
M Medical Device News FDA News - 12-09-18 - MD Submissions to Electronic Format to Improve Efficiency Other US Medical Device Regulations 0
Q Real Time Electronic SPC/Control Charting Statistical Analysis Tools, Techniques and SPC 4
M Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant) Qualification and Validation (including 21 CFR Part 11) 12
L Inspection Process for Electronic Parts from Brokers Supplier Quality Assurance and other Supplier Issues 1
N How is documentation affected moving to an electronic system? ISO 13485:2016 - Medical Device Quality Management Systems 13
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
W ISO 14155 - Electronic clinical data systems - Definition Other Medical Device Related Standards 0
D 21 CFR Part 11 - Electronic Signature Management SOP Other US Medical Device Regulations 0
G Auto electronic signature on Calibration Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S FDA electronic submission gateway (ESG): FAILED eMDR Submission Other US Medical Device Regulations 3
G What's your favourite method of Electronic Folder Filing? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M How to get an electronic version of IATF 16949:2016 which is Searchable IATF 16949 - Automotive Quality Systems Standard 8
J Quality Testing for Tea, Electronic Noses and Such Manufacturing and Related Processes 5
L Sources for Searching Old Electronic Parts Specs (Counterfeit Inspection) Quality Manager and Management Related Issues 3
R Electronic (Online Database) Calibration Records General Measurement Device and Calibration Topics 4
R IEC 60601-2-18 Endoscopic Medical Electronic Equipment question IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
I How much does an eQMS (Electronic/Software QMS) cost? Quality Assurance and Compliance Software Tools and Solutions 1
P Moving from a Paper based Quality System to an Electronic Quality System Manufacturing and Related Processes 14
M ISO 13485:2016 - IQ/OQ Requirements applicable to Electronic Component Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 4
Similar threads


















































Top Bottom