Electronic Paperless Documentation Software Discussion

D

delia628

#1
We are doing paperless project in company, as ISO documents generate a lot of paper jobs. We are think that to do E-documentation.

The function of this software is control internal & external documents which include ISO 9001, 14K & 18K. Control forms and records, engineering change control, etc.

At first I was thinking using lotus notes. But due to some other reasons. It may not be applicable in my company.

May I know what kind of software you are using? Can anyone recommend a software for ISO Document Control? How to put it in practice? does each computer need to install a software?

Or we also can open discussion about the strength and weakness of e-documentation. Wish everyone here share expierence about this.

Thank you!
 
Elsmar Forum Sponsor

PE-2011

Quite Involved in Discussions
#2
Re: E-Documentation Software Discussion

Dear Friend,
I don't think there is any particular software for ISO documentation. But e-documentation (paper less work) is possible. We are maintaining e-documentation. Earlier ISO was like as you stated and people frustrating due to specified documentation. However nowadays it is changed and you can keep your documentation softcopies in computer.

What we have done is, whatever software using by each department for their work purpose, that is their record (I mean real routine work, real record). This system I established in my company and all are happy with this system. There is no specified format recording for ISO particularly. But document control is there i.e. document numbering, revision, date etc. all are included in computer system.

Regards
Maheswari
 
T

The Specialist

#6
The company I am with at the moment use 'Achiever Plus' from Achiever Business Solutions Limited.

All documentation including Test Protocols, SOPs, Change Controls, NCRs etc... are generated, stored and controlled using this system.

There are, of course, many other packages out there... but if you are after specifics; this is one you can look at.
 

somashekar

Staff member
Super Moderator
#7
Re: E-Documentation Software Discussion

Dear Mr.Somashekar,

I do not understand your question. Can you explan.
I just mentioned about a perticular company who offer IMS solution. You may visit the link and find more if what software solution they offer suits your requirement. Remember that these are customized for every client.
 

PE-2011

Quite Involved in Discussions
#8
Re: E-Documentation Software Discussion

Thanks Mr.Somashekar.

I just mentioned about a perticular company who offer IMS solution. You may visit the link and find more if what software solution they offer suits your requirement. Remember that these are customized for every client.
 

Pancho

wikineer
Super Moderator
#9
We are doing paperless project in company, as ISO documents generate a lot of paper jobs. We are think that to do E-documentation.

The function of this software is control internal & external documents which include ISO 9001, 14K & 18K. Control forms and records, engineering change control, etc.

At first I was thinking using lotus notes. But due to some other reasons. It may not be applicable in my company.

May I know what kind of software you are using? Can anyone recommend a software for ISO Document Control? How to put it in practice? does each computer need to install a software?

Or we also can open discussion about the strength and weakness of e-documentation. Wish everyone here share expierence about this.

Thank you!
Hi Delia,

Take a look at wikis. Wikis allow easy, quick and inexpensive conversion of paper to web-based documents, and provide many benefits. For more info and links, see the discussion Using a Wiki to Implement a QMS.

Good luck!
Pancho
 
D

delia628

#10
Re: E-Documentation Software Discussion

Dear Friend,
I don't think there is any particular software for ISO documentation. But e-documentation (paper less work) is possible. We are maintaining e-documentation. Earlier ISO was like as you stated and people frustrating due to specified documentation. However nowadays it is changed and you can keep your documentation softcopies in computer.

What we have done is, whatever software using by each department for their work purpose, that is their record (I mean real routine work, real record). This system I established in my company and all are happy with this system. There is no specified format recording for ISO particularly. But document control is there i.e. document numbering, revision, date etc. all are included in computer system.

Regards
Maheswari
Dear Maheswari:

Currently we are using Lotus Notes as Web-based documentation. but there are some limitation. As I need to scanned all approved documents as pdf copy and upload into database. Everyone can access to database to view documents. We still need to print out hard copy and get signatures from management. As well as other official documents.
 
Thread starter Similar threads Forum Replies Date
M Moving to a Paperless Electronic Documentation System - Seeking Ideas Document Control Systems, Procedures, Forms and Templates 45
C Paperless Electronic Documents and Records - Softcopy to Electronic Document Control Systems, Procedures, Forms and Templates 8
K Paperless Electronic Records in a Machine Shop Records and Data - Quality, Legal and Other Evidence 8
kmyers Question about paperless signature - Electronic signatures in outlook emails ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R Electronic Storage of Documents - Paperless System Document Control Systems, Procedures, Forms and Templates 7
A Transition to Electronic Paperless System - How is Record Retention Addressed Records and Data - Quality, Legal and Other Evidence 11
M Paperless Electronic Document and Records Systems Software Records and Data - Quality, Legal and Other Evidence 19
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 3
Q 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 9100, Nadcap and related Aerospace 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
P Moving from a Paper based Quality System to an Electronic Quality System Manufacturing and Related Processes 14
Similar threads


















































Top Bottom