Distribution of controlled documents through e-mail, is it ok?

A

amyisosec

Registered
#1
#1
Hello,
Need advise.
This is regarding control of documents about the distribution of
controlled documents to different areas which we can only reach
through e-mail.

Would it be possible to email controlled documents to designated
document control custodian who is responsible for handling
the said documents and they are authorized to reproduce the said document for distribution as needed.

Issuance and retrieval shall be followed accordingly with the control of document procedure.

Thanks for any advise.

Amy
 
Download Free White Paper
Elsmar Forum Sponsor
Zero_yield

Zero_yield

"You can observe a lot by just watching."
#4
#4
indubioush said:
This works fine as long as you have a method for ensuring out-of-date (or obsolete) revisions are not used.
Click to expand...
Yup. It's audit bait, but it's doable. Make sure the custodian knows where all the copies went. When the forms are updated, make sure the custodian retrieves all the copies for destruction.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
N Controlled Documents Distribution Query - Home Care Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
W Electronic Distribution of Controlled Documents: Validation required? Qualification and Validation (including 21 CFR Part 11) 5
S Distribution List of Controlled Documents Document Control Systems, Procedures, Forms and Templates 5
C Ensuring Documents of External Origin are Identified and Distribution Controlled ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N Does a Document Distribution List need to be a Controlled Document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
H Distribution of Controlled Copies - Document Control Document Control Systems, Procedures, Forms and Templates 10
A Distribution of Controlled Copy vs. Uncontrolled Copies Document Control Systems, Procedures, Forms and Templates 4
C Controlled Documentation Distribution Log Document Control Systems, Procedures, Forms and Templates 3
P Distribution of "CE" Declaration of conformity under MDR EU Medical Device Regulations 3
M Supplier Evaluation for Cold Chain Distribution of Human Tissues Supplier Quality Assurance and other Supplier Issues 3
I Importing medical device into Canada for exclusive distribution in the U.S. Medical Device and FDA Regulations and Standards News 1
S IEC 60601-1-11 Requirements related to Storage and Distribution IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
JoCam Responsibility for Distribution Agreement EU Medical Device Regulations 2
A How to control distribution list? Document Control Systems, Procedures, Forms and Templates 2
A Need to calculate tolerance Intervals with a set of non-normal data and 3-Parameter Weibull distribution Using Minitab Software 0
D Distribution Center mandatory addition to Certificate? IATF 16949 - Automotive Quality Systems Standard 3
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 6
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
D Private Label Distribution - US Other US Medical Device Regulations 2
D Question regarding "storage and distribution" ISO 13485:2016 - Medical Device Quality Management Systems 1
M Proof of distribution - FedEx/UPS tracking numbers Manufacturing and Related Processes 2
O Are power distribution units Multiple Socket Outlets (MSOs)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
JoCam Medical Device Distribution in the UK EU Medical Device Regulations 6
M Prescription medical device distribution licenses in the U.S US Food and Drug Administration (FDA) 3
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M US distribution Medical Device Medical Device and FDA Regulations and Standards News 8
0 Interesting Discussion Analysis of half normal distribution in minitab Using Minitab Software 11
Marco Bernardi Finding a flat or not modeling distribution: how to manage it? Capability, Accuracy and Stability - Processes, Machines, etc. 24
T Was Just told we could ONLY buy material for AS9100 customers if the DISTRIBUTION house is AS9100 / AS9120 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Medical Device not on commercial distribution but installed in the establishment. 510k? Other US Medical Device Regulations 10
M How do you Audit an Distribution Facility according to MAQMSR IATF 16949 - Automotive Quality Systems Standard 8
K Inspection Certificate EN 10204 2.1 - Distribution company Other ISO and International Standards and European Regulations 4
S Medical Device Software Distribution for a CE-marked medical device via a USB memory stick EU Medical Device Regulations 8
L How to evaluate the process capability of a data set that is non-normal (cannot be transformed and does not fit any known distribution)? Capability, Accuracy and Stability - Processes, Machines, etc. 14
K Distribution medical devices to US Embassies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P AS9120B Control of External Providers for Franchised Distribution AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
C IATF 16949 - RSL - Distribution Center Clasification IATF 16949 - Automotive Quality Systems Standard 3
S Ways to attract clients - Flyer distribution in Toronto, Canada Service Industry Specific Topics 1
N Apply control limits to a non-normal distribution Statistical Analysis Tools, Techniques and SPC 13
G Plotting capability study data - I have a bimodular data distribution Capability, Accuracy and Stability - Processes, Machines, etc. 4
Sidney Vianna ISO 13485 Certificates Distribution around the World - 2018 ISO 13485:2016 - Medical Device Quality Management Systems 4
F Definition Commercial Distribution - Definition - Scope of Commercial Distribution Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
R Non-normal Distribution Selection where the system is constantly being corrected Capability, Accuracy and Stability - Processes, Machines, etc. 11
J Distribution and PPAPs for products they do not manufacture APQP and PPAP 3
G Uncertainty Experts - ISO 17025 - If the Distribution is Rectangular Measurement Uncertainty (MU) 2
D Distribution of a Class 3 Medical Device EU Medical Device Regulations 4
K Distribution Centers - NSF Audit Qualification and Validation (including 21 CFR Part 11) 1
A Not all characteristics follow a Normal Distribution - How do you do SPC Chart Capability, Accuracy and Stability - Processes, Machines, etc. 5
F Distribution Records required by FDA - 21CFR820.160 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Process Capability for parameters with non-normal distribution. Capability, Accuracy and Stability - Processes, Machines, etc. 16

Similar threads

Top Bottom