Electronic Doc Control Software Packages

  • Thread starter Brenda Mundroff
  • Start date
B

Brenda Mundroff

#1
#1
I have been tasked with comparing doc control software packages. Specifically, Qualtraxx vs. ISOXpert. Anybody got info on these that might help?
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 29
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
D Question on electronic signatures and initials on batch records ISO 13485:2016 - Medical Device Quality Management Systems 3
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
blackholequasar Price Gouging? (Electronic components) Manufacturing and Related Processes 9
H Prodigit DC Electronic Load - Drawing current but showed 0 on the screeen Manufacturing and Related Processes 0
M Design Control - Management of Electronic CAD files Design and Development of Products and Processes 14
M Correcting Electronic QMS Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Electronic forms QMS Document Control Systems, Procedures, Forms and Templates 12
S Reporting REACH - Electronic components distributor REACH and RoHS Conversations 5
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 6
D Advice on capturing electronic signatures ISO 13485:2016 - Medical Device Quality Management Systems 8
C Shelf life electronic components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Cleaning of electronic transmitter Other Medical Device Related Standards 2
D Preservation of Electronic Data / Information Technology ISO 13485:2016 - Medical Device Quality Management Systems 5
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
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 11
QIE Electronic IFU - new project, need input Other Medical Device and Orthopedic Related Topics 1
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 2
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

Similar threads

Top Bottom