Electronic Storage of Documents - Paperless System

R

Rockanna

#1
Our company is moving to a paperless system. We are scanning our qualtiy documents, contractual documents, supplier documents, etc.

What software system does your company use to index these type of documents? H
Have you elminated all offsite storage of documents?

We are not looking for Vendors to call upon us; we want some advice from USERS of the software.
 
Elsmar Forum Sponsor
M

mshell

#2
I went through the same thing about 2 years ago. It is a lot of work (good luck). We stored all of our files in PDF (Adobe) format. It is a program that most organizations have and if they do not have it, they can download it at no charge. Hope this helps. :bigwave:
 
Last edited by a moderator:
D

David Hartman

#3
Rockanna said:
Have you elminated all offsite storage of documents?
But have you given consideration to offsite storage of the computer files? (For disaster recovery) :bigwave:
 
R

Rockanna

#4
Reply - CD & DVD's Stored In Bank Vault

In response to CD or DVD's, we store a copy offsite in a bank vault along with our network backup tapes.
Since 9-11, we have attempted to ensure we are covered in that area.
 

Wes Bucey

Quite Involved in Discussions
#5
Rockanna said:
Our company is moving to a paperless system. We are scanning our qualtiy documents, contractual documents, supplier documents, etc.

What software system does your company use to index these type of documents? H
Have you elminated all offsite storage of documents?

We are not looking for Vendors to call upon us; we want some advice from USERS of the software.
I've tried a lot of different software over the past five years (working copies and demo copies.)

I've never found the perfect one which meets all criteria, but several which have fit pretty well with my organization at that time.

I have been using paperless systems since 1992 when I wrote my own tracking system using Access and a lot of macros to generate needed shipping documents and labels without having to re-enter data. I confess now that I thought I needed "my own system" to keep control. What I ended up with was a "Tiger by the tail" which had me constantly tinkering as I discovered new things to address.

My philosophy has now changed 180 degrees to buying everything off the shelf from a company I hope can stay in business to give me updates as they become available.

Look at my post
http://elsmar.com/Forums/showthread.php?p=63324#post63324
to get some idea of how our system operates. I am sorry, but I make it a personal policy never to praise or bash a commercial organization by name in a forum like this, so I won't give you a company name of the software provider.

If you are curious about my ideas of criteria to consider in choosing document management software, send me an email or private message. If I get too many replies, I'll post the criteria for the Cove.
 

Wes Bucey

Quite Involved in Discussions
#6
Rockanna said:
In response to CD or DVD's, we store a copy offsite in a bank vault along with our network backup tapes.
Since 9-11, we have attempted to ensure we are covered in that area.
Might I suggest you explore an automatic nightly (or more frequent) backup to one or more offsite servers via a Virtual Private Network? If any one server fails, you can always connect to one of the remaining ones and have a practically seamless transition. Servers can be bought and placed in branches or you can contract for server space at a commercial "server farm" with 24/7 maintenance of server and "backbones" to the internet.
 

bpritts

Involved - Posts
#8
We use IQS as our doc't distribution system. It provides all of the controls
that you need to meet ISO 9000. I'm not thrilled with its user interface, but
it works. We looked at a number of other systems at the time (4 or 5 years
ago) and this was the best for its price range. When we purchased you
had to commit to the whole product suite but I believe that it now can be
unbundled.

One other neat little product is called QuickView Plus. This is a general purpose
file viewer program. If you need to be able to view files from a zillion different
formats (autocad, MS Word, Excel, Word Perfect, JPG, BMP, etc...) this one
program can do them all. It doesn't do the control functions but it allows you
to read any file from any workstation without installing the applications.
This is important if you need to have lots of PC's reading files from different
applications. It was very cheap to get on a site license basis (again, this
was about 5 yrs ago; not sure what their terms are now. For a while,
it came free with Word Perfect. ) This would save you the trouble of converting
a bunch of old files to PDF's. You work out the cost benefit; it will depend on
how many files and app's you have.

Regards,

Brad
 
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
K Storage of Electronic Backup Data? Document Control Systems, Procedures, Forms and Templates 6
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
R Electronic and hand-written footnotes for GDP Document Control Systems, Procedures, Forms and Templates 1
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
qualprod 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, NADCAP and Aerospace related 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

Similar threads

Top Bottom