SBS - the best value in QMS software

Acceptable methods to store and archive records

X

xtaticblue

#1
#1
This may have been discussed before but I have a simple question.
I think I know the answer, but wondered if anyone had there own opinion before I start shredding paper!!

The question is;

Is it acceptable to pdf/scan records and store them electronically (remote server obviously) rather than store boxes and boxes of hard copies?
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
Jim Wynne

Jim Wynne

Staff member
Admin
#2
#2
xtaticblue said:
This may have been discussed before but I have a simple question.
I think I know the answer, but wondered if anyone had there own opinion before I start shredding paper!!

The question is;

Is it acceptable to pdf/scan records and store them electronically (remote server obviously) rather than store boxes and boxes of hard copies?
Click to expand...
ISO 9001:2008, 4.2.4, in part:
The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.
Records shall remain legible, readily identifiable and retrievable.
Click to expand...


Those are the requirements and they can be easily satisfied by electronic storage.



 
X

xtaticblue

#3
#3
So it's as I thought. If we say that's what we do, and it satisfies the standard, we're ok to start scanning and shredding!

Thanks for the confirmation.
 
P

prady2581

#4
#4
Hi
I agree, Standard says that it can be any medium and shared some guidance as an example. As far as you satisfy all elements of control of records clause you are compliant.

But remember - PDCA ? you have to evaluate continously for any improvement opportunities.
 
M

Mark Meer

Trusted Information Resource
#5
#5
Before you fire-up that shredder...

Although this thread is in the ISO 9001 forum, I would caution you to also consider regional regulatory requirements as well.

For example, it has been debated in these forums before as to whether a scanned signature is still legally valid from an US FDA perspective (my position is that it is, though others would disagree).

So, while this may be ok as far as ISO, there may be regulatory bodies that still might want to see the "originals"...
 
I

Illek

#6
#6
:2cents:

We just had to change our disposition of records because of a customer requirement. May want to check those too.

Illek
 
X

xtaticblue

#7
#7
Good points made. Thanks all for the input. It has made me think I'd better check on other standards that may 'influence' our system. TS16949 springs to mind but I'm not to hot on it without a bit of research.
 
E

Eredhel

Quality Manager
#8
#8
It would be interesting to know about the regulation side. I did a trademark about 9 years ago and I digitally signed everything with the government office. Obviously a different branch but I'd hope a decade later that would make it's way around.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Comparing Two Test Methods - Acceptable Difference(s)? Statistical Analysis Tools, Techniques and SPC 3
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
M Measurement Error - How to determine what is acceptable? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
M Are Fungal counts acceptable in class 1000 clean rooms? Other ISO and International Standards and European Regulations 2
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
samer Acceptable limits for Spills - Tracking Hydraulic Spills ISO 14001:2015 Specific Discussions 3
V Acceptable maximum RSD (relative standard deviation) for an sample size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B Gage R&R Acceptable (10-30%), deduct Total Variation from Tolerance Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Q Acceptable calibration accuracy of a 60" linear measuring device General Measurement Device and Calibration Topics 16
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
Q Is it acceptable to mix components from two different lots into an assembly? ISO 13485:2016 - Medical Device Quality Management Systems 1
C Acceptable NDC for %GR&R part inspection to Tolerance (%Tolerance) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Operator Checks - How to show that they were completed on a checklist as acceptable IATF 16949 - Automotive Quality Systems Standard 2
C Example Work Instruction/Procedure for AQL (Acceptable Quality Level) AQL - Acceptable Quality Level 4
S Dates on Labels acceptable to the USA - GS1 General Specification 3.4.4 Other US Medical Device Regulations 3
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
W Unattached (stand-alone) Forms acceptable for AS9100C? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
V Why Gauge R&R 10% is acceptable for variable instruments ? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
M Is it acceptable to audit to the Nuclear Principles? Quality Manager and Management Related Issues 9
I Is it acceptable it is to list new products under an existing 510(k)? Other US Medical Device Regulations 14
S If this EN ISO 11137 certificate acceptable for Contract Sterilization? ISO 13485:2016 - Medical Device Quality Management Systems 2
D What is satisfactory & acceptable for Coliform - Staphylococcus - Hands and Surfaces Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Is a Dynamic Controlled Form acceptable per 21CFR820 Document Control Systems, Procedures, Forms and Templates 3
C Lowest Acceptable Grade for Master Gage Set Calibration and Metrology Software and Hardware 1
B Digital Signature Solutions acceptable to use in an FDA Medical Device Environment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Is a ndc less than five is also acceptable? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
T Technical regulations that determine the acceptable limits of cigarettes General Measurement Device and Calibration Topics 4
L IEC 60601-1 3rd edition Clause 9.2.2 Trapping Zone (Acceptable Gaps) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is it acceptable to sterilize products without claiming and labeling "sterile" ? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Quality Objectives - Acceptable Levels and Functions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
D Is embedding documents within a Contract an acceptable practice ? Contract Review Process 9
B Non Acceptable % Tolerance Result - Decrease Sorting Limits Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
F ANSI ASQ Z1.4 - Is the following process acceptable? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
C Maximum acceptable Tolerance - Uncertainty Ratio (TUR) General Measurement Device and Calibration Topics 2
S Is it acceptable to have an ASL for Critical suppliers alone? Supplier Quality Assurance and other Supplier Issues 4
S Is this Quality Policy acceptable in the context of ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 24
A Help with acceptable screw gage values per standard BS 919 for Go/ No Go gage General Measurement Device and Calibration Topics 4
S What are typical Acceptable Quality Levels (AQL) adopted in Food industry? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
somashekar Who can provide a WHO GMP certificate in India acceptable to the CDSCO Other Medical Device Regulations World-Wide 6
D Root Cause and Corrective Action - Is our Practice Acceptable? ISO 13485:2016 - Medical Device Quality Management Systems 5
W Application of AQL (Acceptable Quality Level) Concept AQL - Acceptable Quality Level 15
H Acceptable Time to provide proof of CAR (Corrective Action Report) Nonconformance and Corrective Action 4
A Sample Size for Mathematical Model with acceptable Confidence Level Using Minitab Software 7
M AQL (Acceptable Quality Level) for Mixed Part Defect IATF 16949 - Automotive Quality Systems Standard 1
S AQL (Acceptable Quality Level) Report Form example wanted AQL - Acceptable Quality Level 1
M What is an acceptable PPM for large volume fasteners? APQP and PPAP 6
K How do you determine what is acceptable base on an FMEA RPN FMEA and Control Plans 6

Similar threads

Top Bottom