Moving to a Paperless Electronic Documentation System - Seeking Ideas

#11
energy said:
You know, the old "If it ain't broke. don't fix it." Just make sure it is worth it and not an attempt to look more efficient. Just another viewpoint. :agree:
Very good point Energy. I agree. We had an extensive computer network alreay in place when we opted to do away with most of the paper documents (We have cut the paper mountain down to perhaps 5-10% of what it used to be). So we are not entirely paperless even today. We have a "mixed" system, with most people accessing the documents via computer and just a few via paper.

/Claes
 
Elsmar Forum Sponsor
M

Marla Diaz

#12
Guys,

Thank you very much for replying to my query!


Dear Energy,

Our ratio of computer to user is 1:1 so I guess there will be no additional purchases. There would be little or no resistance at all because all would be users are pc users.

So as Randy said, I really need our IT guys to help me map out our documentation before I even present the idea to management.

Would you give me a rough estimate on how long this process would take? Our docs are all in word and powerpoint.

Thanks,
Marla
 

SteelMaiden

Super Moderator
Super Moderator
#13
Marla, if your docs are all in MSOffice, it should be relatively easy to just save them as web pages. I believe that there are ways to convert entire directories, once again IT should be able to assist you. I have always created everything in html, and even that goes quickly because you can just reformat your .doc .xls and import powerpoint web files. It all depends on the amount of documentation and how much time you can dedicate but you should be able to set up some sort of web based system and get your conversions done in 4-6 weeks easily even if you have a fairly large amount of documentation.
 
R

Randy Stewart

#14
Marla,
The main reason to map it out is so you don't set up links and databases that once transfered, to the web page, lose the links. Using Excel for flow charts and links to forms can be a real value, plus conversion to HTML is simple.
 

Wes Bucey

Quite Involved in Discussions
#15
Documents can stay in native format.

Here's an intro to one of my presentations on the topic:

Document Management Software



Background:

An organization wants to improve efficiency of document management by “grafting” a program over current legacy files and all newly-created files which will provide the following minimum benefits:



  • Ease of Search & Retrieval (on different fields/characteristics)
  • Ensure only the most recent revision is available on standard Search menu
  • Automate the procedure of notifying pertinent parties a document is ready for redlining
  • Maintain an audit trail for the status of documents (released or waiting for checking/approval [and by whom])
  • Allow “full preview” of documents without opening native programs – i.e. AutoCAD documents can be viewed without latest revision of AutoCAD being resident on user’s computer.
  • Permit “group printing” of documents, regardless of native file format.
  • Maintain up to 30 security levels on any document, determining whether user has authority to create, modify, redline, view, print, copy, etc.

How do they work?

The primary feature of Document Control Software is a relational database which manipulates very small files called “metatags”, which relate to certain attributes of documents. Basic attributes are file name, revision level, author, topic, key words, type of file format, etc. which are used for field headings in the database.



By querying the database, a user retrieves a “menu” of documents which meet the search criteria. Self-contained viewing software permits a user to view and print documents, regardless of the native file format. The views can be scrolled, zoomed, and cropped (i.e. user can print an enlarged detail of a document.)



Users who have redline authority can markup documents without invoking the native file program (the redlines are saved as “overlays” in separate files without changing the original document.)



Users who have checking/approval/redline authority can be automatically notified via email when a document is ready for their review. The program will track when and whether the review is completed and maintain an audit trail for “real time” status reports on any or all documents in the review process.



By keying on the attribute “Revision level”, the program can ensure only the most recent, authorized revision is available to most users, reserving authority to view “superseded” documents to special categories of users.

An important consideration in grafting legacy documents into the new system is choosing fields pertinent to the organization. Many documents, like autocad and word documents have features which provide automatic tags (create date, author, department, etc.) [click on "properties" under File in a Word document to get an idea of already available fields.]

The problem is most users write documents which still show "valued customer" as the author because they have never explored the Properties feature.

An expense to consider is going back into each legacy document and adding the meta tags which allow for sorting and retrieval.

I hope this helps - there are many consultants like me who would come in and give your organization background on choosing the best brand for your organization. Caution is "Are they truly independent or do they have bias toward one brand?"
 
C

cyd_k

#16
We use the properties window (avalaible in Excel & Word) to list the reason for change and the effective date. A disclaimer is on the bottom of documents mentioning it is the users responsibility to ensure their hardcopy matches the softcopy published...The publish date is in the document header which is then posted to an intranet site (as a pdf file) that is write locked to all the company but myself and the IT group to ensure security. Employees can retrieve original format documents and save them to their PC to make changes then route to others for approval before submitting the revised document. I then pdf and post the new document along with a company wide email containing a brief message about the change and the link as well. This avoids purchasing any kind of software and only needs a simple web page design eliminating huge amounts of IT time.
 

Raffy

Quite Involved in Discussions
#17
Paperless System

Hi Kel,

Woh....its been two weeks the last time I logged in. Well, basicallly
in your case, Paperless in the System, is very helpful. In our case,
our IT manage to set-up a database using Access database.
Try to study the value of setting up a paperless system, in terms
of cost, so that the management would try to evaluate your proposal.

Hope this helps.

Best regards,
Raffy
 
G

gheghe

#18
I have seen one company with a very good computerized documentation system, we can benchmark their system. Goin through Paperless not necessarily totally mean paperless, we still need to have a hard copy and it will need a study as raffy said. Need to consider a lot of things.
 
P

pthareja

#19
Paperless documentation

Bravo cove'rs,
The thread was very informative and thought provoking. Well! from the environmental angle: preserve trees. I believe pollution starts the moment you think of using a paper, unless the local stuff was made from non conventional raw materials.
Management of soft copies may be difficult if not properly done: retrievability relegated to software design ruggedness and maintenance, however it may be painless if done well. But the life of hard disk is not that predictable as the storage is. Backcopy in both places.
I think environmental angle should take up the score. If that wasn't there, the journey to easier storage through microfilming etc may not have seen light.
So Go for paperless.Marla Diaz

Wish you best of luck1
Thareja
 
W

WALLACE

#20
Paperless documentation?!

I am in the process of helping a client to convert to a paperless system using Mind mapping software.
Attached is a screen shot example of this kind of format.
Wallace
 

Attachments

Thread starter Similar threads Forum Replies Date
M Moving from physical signatures to a paperless QMS - Process and approval sign offs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
D Quality plan for moving locations ISO 13485:2016 - Medical Device Quality Management Systems 3
qualprod What do CB´s change when doing a partial moving ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Earthing of moving parts, designing tips IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S How MR (Moving Range) in Z-MR chart is calculated Using Minitab Software 5
A Moving and positioning of patient - Mechanical hazard IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
D Company Moving - Relabelling Question Medical Device and FDA Regulations and Standards News 0
Jen Kirley Moving on - I accepted an offer to be a Supplier Quality Engineer at GE Healthcare Coffee Break and Water Cooler Discussions 42
S Moving from client-server to cloud-based, is that a new submission? Medical Information Technology, Medical Software and Health Informatics 3
M How to calculate benefits? Moving some developed non controlled software/automation systems Service Industry Specific Topics 2
Ed Panek Moving from Contract Manufacturing to Production In-House ISO 13485:2016 - Medical Device Quality Management Systems 3
supadrai What to expect when moving to higher-risk medical devices? Other Medical Device and Orthopedic Related Topics 1
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
N How is documentation affected moving to an electronic system? ISO 13485:2016 - Medical Device Quality Management Systems 13
L Moving from ProArc to IFS Document Management Document Control Systems, Procedures, Forms and Templates 1
K Sister Company Moving to AS - First time "consultant" - Help? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
I Moving into Clinical Trials and need to find GMP Suppliers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Moving (Transition) From ISO 14001:2004 to ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
P Moving from a Paper based Quality System to an Electronic Quality System Manufacturing and Related Processes 14
S Validation requirement after moving labeling data base to different drive Software Quality Assurance 7
Q REACH due dilligence and meeting the ever moving SVHC target RoHS, REACH, ELV, IMDS and Restricted Substances 5
C Moving to a different Notified Body Quality Manager and Management Related Issues 5
R What Documentation is done by QA in FMCG (Fast Moving Consumer Goods) Misc. Quality Assurance and Business Systems Related Topics 2
T Risk Analysis for moving manufacturing equipment ISO 14971 - Medical Device Risk Management 17
C ISO9001: Moving from site certification to corporate certification Quality Manager and Management Related Issues 9
T Moving a Calibration/Test Laboratory to a new Location General Measurement Device and Calibration Topics 5
R Moving from ISO 9001 to AS9120A Document Control Systems, Procedures, Forms and Templates 2
Q Moving steps from ISO 9001 to TL 9000 TL 9000 Telecommunications Standard and QuEST 4
M SPC, Moving Range Chart and Weighted Graph Basic Questions Statistical Analysis Tools, Techniques and SPC 1
N Protective Earthing of Medical Device Moving Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
F Moving our Distribution Company - ISO 9001 Certification Impact ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N NCR and CAPA in the FMCG (Fast Moving Consumer Goods) Industry Nonconformance and Corrective Action 1
D A2LA Certification and moving to a new Facility General Measurement Device and Calibration Topics 6
S Moving to a New Company for a New Position Coffee Break and Water Cooler Discussions 3
D IMR (Individuals and Moving Range) Chart for Short-Run SPC - How much data to include Statistical Analysis Tools, Techniques and SPC 1
S Validation and Qualification when moving to another Facility Qualification and Validation (including 21 CFR Part 11) 2
L Moving SPC Data from Variables to an Attributes Chart Statistical Analysis Tools, Techniques and SPC 4
S Advice on moving QMS Documents and Maintaining Revision History Quality Manager and Management Related Issues 9
N Requirements when moving locations - Class 1 Medical Device Manufacturer in the US Other Medical Device Regulations World-Wide 4
D AS9100 Shop Moving to a New Location AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Moving On Coffee Break and Water Cooler Discussions 12
C Test Correlation - Moving Test Equipment to a New Location Manufacturing and Related Processes 7
W Moving M&TE (Measuring & Test Equipment) to New Facility General Measurement Device and Calibration Topics 3
E Moving Window Test - Is this test about determining the Threshold Voltage? Quality Tools, Improvement and Analysis 2
D Moving Manufacturing Equipment from USA to Europe - Is CE certification required?? CE Marking (Conformité Européene) / CB Scheme 12
R Moving to an Electronic System - Quality System Software Recommendations ISO 13485:2016 - Medical Device Quality Management Systems 5
S ISO 13485 - Moving towards common (single) certification for multiple locations ISO 13485:2016 - Medical Device Quality Management Systems 13
R Preventative Maintenance - Moving to a Predictive Maintenance Program Manufacturing and Related Processes 10
L Validation Plan Requirements when moving to a new Plant - Medical Device Industry Qualification and Validation (including 21 CFR Part 11) 19
V Supplier Moving Manufacturing Location after original PPAP APQP and PPAP 4

Similar threads

Top Bottom