Storage of Electronic Backup Data?

K

keyplas - 2006

#1
#1
Storage of electronic Back up data?

Ok...I have been asked the question and need to find an "Official Sounding" answer...With regards to electronic data that has been backed up, is there ANY requirement as to how/where it is stored? I scoured and found no such statement, the QS requirement for a contingency plan may cover this but not this situation specifically....HELP the I.T. guy is driving me crazy
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
E Wall

E Wall

Just Me!
Super Moderator
#2
#2
The only requirement I am aware of is for Record Control. Since back-up data is your method of storing records it must be done in such a way that the data is retrievable when needed (an provided protection from degradation).

Other than that I would suggest that Monthly tapes (or whatever media used) be stored off-site to provide protection in regards to disaster planning.

We perform back-ups 1/day (updated/new files), 1/week (updated/new files & programs, 1/month (complete backup of entire system {files and programs}) with the monthly tapes sent out and stored for 3 years.

Best of luck, Eileen
 
A

Al Dyer

#3
#3
Keyplas,

I know the pain, and I would include it under either contingeny plan or record retention. Either is acceptable as long as it is addressed.

I don't know your IT person, but the schedule Ewall put forth sounds good. My only addition might be the following:

Have a fire-proof safe for the daily, weekly, monthly backups. Also, have a place to take a copy of the daily back-up, it might be your home. With the technology today, we can keep a daily copy on-site as well as keep an additional copy away from the "plant".

Just remember that no system is failsafe, only gradually trying to attain it. I know one company that backs up every night at 7:00 PM onto 3 tape drives. 1 person is responsible to take those tapes to 2 people in the company for stirage, the other one is kept in a safe on premise.

Overkill, that's a company by company choice.

MHO
 
D

db

#4
#4
Backup What?

keyplas, the big question is why are you backing up? It really makes no difference whether you are backing up data/records, or documents, the rules would still be the same.

ISO/QS doesn't care 'how' you perform your backup. If you have a 'need' for backing up data, then back it up. The method you choose must meet YOUR need. If on-site backup will work, then do it. If you need off-site backup then do that!

A company I work with electronically backs up all their records (in some cases requiring scanning) once a year. They then make three copies of the CDs. The first copy they keep at the site in Michigan. The second copy goes to their attorney and the third goes to their Mexico plant. They figure in order for all three copies to fail, then either there were three separate, simultaneous events (in which case they would be out of business), or one common event (in which case we would all be out of business)

The point is the rules: 1. must be yours and 2. must work. It all goes back to the question why do you need to perform backups?
 
A

Al Dyer

#5
#5
Dave B.,

100% agree, there are no method requirements, just a simple requirement that all businesses and (to a point) individuals should follow.

I don't know about you, but I have been caught with my hard drive down and don't want it to happen again.

Have a good day, and a good life to your hard drive!
 
J

JRKH

#6
#6
Keep It Simple

Keyplas,

I can't add much to what has already been said, except to keep it as simple as will work and the comapny is comfortable with.
I am informed by our consultant, (the venerable Marc Smith of Elsmar (nee Cayman) Cove fame) that some IT fellows back up their system and toss the tape in the back of their car. This seems to be perfectly acceptable with auditors.

James
 
K

keyplas - 2006

#7
#7
Thank You all...

It turns out my assumptions (in agreement with all of you) were correct, The majority of their (the I.T group herewith referred to as the MIA when ya need em group) concern was driven by the finance department and the need to have money matter documents/history stored and safe (no I don't work for ENRON) I let them know that as long as the storage container/area was protected from theft,damage,deterioration etc. it didn't matter where they kept it (thats when I was informed the CAD department backups are stored in employee x's garage) but that's another battle...Tha nks Again:frust:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Supplier Approval of electronic document storage service ISO 13485:2016 - Medical Device Quality Management Systems 8
D Centralizing the Receiving and Storage of Electronic Customer Data Document Control Systems, Procedures, Forms and Templates 1
V 21 CFR Part 11 Electronic Data Storage Requirements vs. Paper Records Qualification and Validation (including 21 CFR Part 11) 2
J Storage analysis up to 18 months - Electronic equipment Various Other Specifications, Standards, and related Requirements 3
F Electronic Media Storage - What is the shelf life of recorded CDs? Records and Data - Quality, Legal and Other Evidence 7
R Electronic Storage of Documents - Paperless System Document Control Systems, Procedures, Forms and Templates 7
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
Anonymous16-2 Dietary Supplement Raw Material/Component Storage and Production Manufacturing and Related Processes 1
C Ambient temperature_how we claim storage condition in label? Other Medical Device Related Standards 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
D Cleanroom Cleaning Products and Storage Other Medical Device and Orthopedic Related Topics 18
S Medical device storage conditions Other Medical Device and Orthopedic Related Topics 1
E OSHA - 1926.252(e) - Oily Rag Storage Occupational Health & Safety Management Standards 22
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
T QMS - Documentation Cloud Storage EU Medical Device Regulations 0
K How to verify the Storage and Transport environmental condition for Medical Device Miscellaneous Environmental Standards and EMS Related Discussions 3
T 5ºC Storage Temperature Validation - Urology disposable devices EU Medical Device Regulations 3
Q Weigh Scale Electronics - Suggested Storage Humidity and Temperature Manufacturing and Related Processes 7
S Document Storage/Archival Procedure Document Control Systems, Procedures, Forms and Templates 18
shimonv Storage Conditions of 5-40 Celsius - Accelerated and real time aging - Dilemma EU Medical Device Regulations 3
O Storage of Calibrated Tools General Measurement Device and Calibration Topics 12
T Validation of Dropbox for File Sharing, Storage, and Retrieval ISO 13485:2016 - Medical Device Quality Management Systems 10
M SOP or template for a study to Define Storage Conditions of Orthopaedic Implants EU Medical Device Regulations 3
R Saudi Arabia - Temperature Storage Requirements Other Medical Device Regulations World-Wide 4
D Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements EU Medical Device Regulations 5
Y Process Characteristics for Inspection and Storage FMEA and Control Plans 4
R Medical Device Storage Temperature Tests and Requirements EU Medical Device Regulations 14
D Requirements for Storage of Food Allergen Ingredients Manufacturing and Related Processes 1
T Sterile Medical Device Storage Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
A Hazardous material storage shed flooring material Miscellaneous Environmental Standards and EMS Related Discussions 6
R Digital Storage of ITAR Controlled Documentation Other ISO and International Standards and European Regulations 7
L Intellectual Property Protection - Storage, Access, Distribution, etc ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B IEC 60601-2-24 - Defining Storage Volume IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Determining the "storage volume" (ISO 8536-8:2004 clause 6.14) Other Medical Device Related Standards 4
A FDA guidance for MDDS, Medical Images Storage, Medical Image Communications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
A Calibration/Verification of thermo-hygrometer in storage areas ISO 13485:2016 - Medical Device Quality Management Systems 9
W Micrometer Storage while not in use General Measurement Device and Calibration Topics 4
shimonv Storage of finished medical devices per 21 CFR Part 820.150 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A Cleaning of Medical Device Storage Areas ISO 13485:2016 - Medical Device Quality Management Systems 1
E Empty Test Tube Storage - Suggestions Please Manufacturing and Related Processes 8
A Outsourced Processes Control (Finished Medical Device Delivery, Storage) ISO 13485:2016 - Medical Device Quality Management Systems 10
S Package Storage Direction in an I.T. Warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Storage Temperature Marking for something Temperature Degrades IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Storage Symbol for Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
M Critical Limits for CCP in a food storage warehouse Food Safety - ISO 22000, HACCP (21 CFR 120) 4
S Insulin Pen Injector Storage Requirements Other Medical Device and Orthopedic Related Topics 1
AmandaMusser How are Storage Requirements Determined for Epoxy, Paste, Solder, etc. ISO 13485:2016 - Medical Device Quality Management Systems 6
M Temperature and Humidity requirements for Raw Material Storage and Quality Labs IATF 16949 - Automotive Quality Systems Standard 13
S Checklist for a Chemical Storage Audit Document Control Systems, Procedures, Forms and Templates 12

Similar threads

Top Bottom