SBS - The Best Value in QMS software

Software for handhelds (Palms, Clie') that has ISO internal auditing programs

B

Brad Serangeli

#1
Quick question for the "Covers"..
Anyone know of software for handhelds (Palms, Clie') that has ISO internal auditing programs? Thinking about trying this if available.:rolleyes:
 
Elsmar Forum Sponsor
B

Brad Serangeli

#3
Dave,
Thnks for the info. I think that when i get at least 20-35 posts I can classify myself as a "cover".
 
C

Craig H.

#4
Brad:

FWIW, my external auditor uses a handheld for our audits - actually for all of their audits.

During the audit, it takes him about as long to type his notes in as it does for me to jot mine down. Although his printer problems prevented him from doing this last time, he usually takes over my office after the audit for about 45 minutes, then he uses an IR connection to his portable printer, and he leaves me with a hard and soft copy of the audit report before he leaves.

It is much easier on everyone involved.

The software is propriatary, though.
 
G

Greg B

#5
Craig,

My guy takes notes. Transfers to a laptop and gives me the same (Hard/Soft Copy) before he leaves. It is much more practical and efficient. He does not use any fancy software, just forms he has designed as 'electonic' in word ie used the 'forms' button on the toolbar.
I've been thinking of getting a PDA but I do not know how practical they would be. Maybe we should start a Thread.

Greg B
 
Thread starter Similar threads Forum Replies Date
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
D Integrated Management System Software Quality Manager and Management Related Issues 2
B Sampling strategies/techniques for software QA Software Quality Assurance 2
K MDCG-2020-3 (about the software of UI) EU Medical Device Regulations 0
D PFMEA Software search IATF 16949 - Automotive Quality Systems Standard 6
C MDR software classification EU Medical Device Regulations 12
H Class II a vs "software safety class A" IEC 62304 - Medical Device Software Life Cycle Processes 3
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 3
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
Aymaneh UDI-PI Software CE Marking (Conformité Européene) / CB Scheme 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 7
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
L Micro-Vu InSpec Software Program Qualification and Validation (including 21 CFR Part 11) 6
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 5
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C SharePoint Contract Management Software General Information Resources 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
D Safety data sheets software REACH and RoHS Conversations 2
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
S Asterisk in DOE minitab software Using Minitab Software 23
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
bruceian Software Quality Metrics Software Quality Assurance 11
optomist1 How Secure Are Our Software Systems Software Quality Assurance 7
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
O Software for comparing text of PDF files Contract Review Process 2

Similar threads

Top Bottom