Using a wiki for Document Control

Pancho

wikineer
Super Moderator
#1
As mentioned previously, we had a good experience at Geometrica using a wiki for our management system.

Hoping that this experience will help others, we have written a new article on it: Using a Wiki for Document Control. It starts like this:

Change happens and successful organizations embrace it as a spark for improvement. Yesterday’s “way we do things” may be ineffective today, or perhaps even damaging. Work methods must be quickly adapted to condition shifts and knowledge gains. A key component of embracing change is document control, which lies at the heart of any business management system.
Hope y'all will find it useful, and any comments will be appreciated!

Regards,
Pancho
 
Elsmar Forum Sponsor
M

MeredithMay

#2
Do you know if wikis might offer the security required for medical devices? ISO 13485 differs from 9001, and the additional FDA/CFR requirements could throw a wrench in the wiki document control.

How do you handle the required approval of documents?

I am glad to see this concept being discussed!

Meredith
:thanx:
 

Pancho

wikineer
Super Moderator
#3
A

ab001

#4
As mentioned previously, we had a good experience at Geometrica using a wiki for our management system.

Hoping that this experience will help others, we have written a new article on it: Using a Wiki for Document Control. It starts like this:



Hope y'all will find it useful, and any comments will be appreciated!

Regards,
Pancho
:thanks:

very useful. when i get the time and the strength to take on the "old-school" i really want to try something like this.
i've already done the bug tracker to manage our non-conformances.

i like your point about "content is the key" - that's where the money lies. not in formatting arguments.
 

Pancho

wikineer
Super Moderator
#5
i like your point about "content is the key" - that's where the money lies. not in formatting arguments.
Indeed.

Controlling documents by forcing readers to download uncontrolled pdfs is kinda like bringing cookies to a Weightwatchers meeting.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
Thanks for the article, Pancho.
I'm going to pass this on to my DC guy.
The company is balking on an expensive electronic document management system right now. But we already have the intranet to support a wiki.
This might be a good alternative to a bunch of procedures in a folder on a network drive.
 

Pancho

wikineer
Super Moderator
#7
There are many wiki engines that are free, and others cost a really small amount. We started with a program for about $150 dollars per year and it is only recently that we have upgraded to one a bit more expensive (the "enterprise" version) because we are now using wiki spaces for many more applications, including project coordination with our clients.

The page that serves the article is a "static view" of our wiki.
 
M

MeredithMay

#8
I was just speaking with a tech friend of mine about this, and here is some information she gave me:

MLM,
We are looking at purchasing a Wiki to run on our own server vs a "hosted" wiki.

I've been using the WikiMatrix site to look at the possible wiki's we might want. Use the Wiki Choice Wizard to walk you through what you do and do not want/need (EX: Do you want/need Page History?) do you want/need
WYSIWYG, what server operating system are you running if you don't want a hosted wiki, etc.

Use the matrix, it's really helpful!

A

P.S. We used PHP Wiki and Twiki (I think, will look) and didn't like these at all. Not sophisticated enough, etc.
 

Pancho

wikineer
Super Moderator
#9
This might be a good alternative to a bunch of procedures in a folder on a network drive.
Yep. At the risk of sounding like a scratched record, "Blind" files (those that are not immediately visible to a user) go against the spirit of document control because every time a user must consult the file, he or she needs to generate an uncontrolled copy in his or her hard drive.
 
M

machrk

#10
As mentioned previously, we had a good experience at Geometrica using a wiki for our management system.

Hoping that this experience will help others, we have written a new article on it: Using a Wiki for Document Control. It starts like this:



Hope y'all will find it useful, and any comments will be appreciated!

Regards,
Pancho
:applause:Pancho

as we've chatted in virtual space off line from Elsmar Cove ... it seems to me that your wiki approach is really interesting for smaller orgs where team members are all fairly equally competent at using the wiki systems - html/wiki markup language etc

however even on much larger sites I reckon that it provides an innovative approach to doing document review

cheers
KerrieAnne:cool:
 
Thread starter Similar threads Forum Replies Date
C Document Control using Wiki - Cannot Create all Documents as Wiki Pages Document Control Systems, Procedures, Forms and Templates 10
Pancho Interesting Discussion Using a Wiki to implement a Quality Management System (QMS) Document Control Systems, Procedures, Forms and Templates 273
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
J Using ring gauges General Measurement Device and Calibration Topics 2
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
P Can Neoprene be Cleaned Using Isopropyl Alcohol (IPA) Manufacturing and Related Processes 4
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
chris1price Sterilization using beta radiation Other Medical Device Related Standards 2
M Using the phrase "herein referred to" Document Control Systems, Procedures, Forms and Templates 8
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
C Importer shell game - Using a third party logistics provider (3PL) in the EU EU Medical Device Regulations 5
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
Tagin Evaluating nonconformances for escalation using Bayesian methods? Statistical Analysis Tools, Techniques and SPC 2
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Clause 7.7 Replicate, Recalibration and Intermediate checks using Artifact ISO 17025 related Discussions 1
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
A Using Arduino based sensors for Poke-Yoke Manufacturing and Related Processes 6
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
B Using non CE parts in a machine CE Marking (Conformité Européene) / CB Scheme 1
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
A Hospital IT expectations for connected medical device using WIFI Medical Information Technology, Medical Software and Health Informatics 0
Proud Liberal Cp / Cpk on position using multiple MMC bonuses Capability, Accuracy and Stability - Processes, Machines, etc. 2
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
M Raw stock material testing discrepancy using an XRF (x-ray fluorescence) analyzer Manufacturing and Related Processes 7
Z Using FMEA for Knowledge Management FMEA and Control Plans 6
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
J Including Repeats in DoE using Minitab Using Minitab Software 5
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom