Alternative to keeping hard copy records that is 21 CFR part 11 compliant

#1
I'm looking for an alternative to keeping hard copy records that is 21 CFR part 11 compliant, where records can be scanned, indexed, retained for specified intervals and be readily available when needed. Our current (validated) software platform is nearing its end of support period from the vendor and we are looking for alternatives. Thanks for any info/feedback.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
M Informational US FDA – MDR Data Files – Alternative Summary Report Data Since 1999 Available Medical Device and FDA Regulations and Standards News 0
H GHTF and IMDRF - Alternative for the STED format EU Medical Device Regulations 5
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Management Review - Alternative methods Management Review Meetings and related Processes 20
P Alternative To PT/ILC (Inter-Laboratory Comparison) Requirement General Measurement Device and Calibration Topics 3
E Looking for an alternative to a decade box that is unavailable everywhere right now. General Measurement Device and Calibration Topics 7
T Corrective Action Reports - Alternative Formats Nonconformance and Corrective Action 1
P Alternative Procedures to DOA: How to start? EASA and JAA Aviation Standards and Requirements 3
V Alternative to Microsoft Office - Open Office vs. Google Docs After Work and Weekend Discussion Topics 26
somashekar Regulations on Alternative Medicines and Therapy Other Medical Device Regulations World-Wide 1
S ADOA (Alternative Procedures to Design Organisation Approval) Procedures EASA and JAA Aviation Standards and Requirements 1
R TS 16949 Alternative Risk Assessment FMEA, Apendix C Requirements FMEA and Control Plans 5
B Supplier Categorisation - Alternative Systems for Categorisation of Suppliers Supplier Quality Assurance and other Supplier Issues 4
Q Alternative QC tests Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
J Quality Assurance for Complementary and Alternative Medicine (CAM) Hospitals, Clinics & other Health Care Providers 4
Y An alternative title (term) for Quality Policy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
P A slightly alternative Turtle Diagram Process Maps, Process Mapping and Turtle Diagrams 1
M Alternative term for Nonconformance - Finding Nonconformance and Corrective Action 21
A Alternative Selection Excel .xls Template - ISO 9001 and CMMI (DAR Process Area) Excel .xls Spreadsheet Templates and Tools 1
H Achiever Plus - Are there alternative products that are better than Achiever Plus? Quality Assurance and Compliance Software Tools and Solutions 5
M Alternative to AVG - ClamWin After Work and Weekend Discussion Topics 13
F Seven Quality Tools diagrams and charts software - Excel alternative? Quality Tools, Improvement and Analysis 9
T AWS or Other Alternative Welding Spec for HSLA 590 Steel (2mm thick)? Misc. Quality Assurance and Business Systems Related Topics 1
J Run Charts and Alternative Process Control Parameters Statistical Analysis Tools, Techniques and SPC 5
C Alternative Internal Audit Methods - Seeking Enlightenment General Auditing Discussions 68
S Telecommuting as an alternative to relocation Career and Occupation Discussions 3
G Chlorine dioxide for medical use - Alternative for the disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 5
C Another Browser Alternative After Work and Weekend Discussion Topics 10
S Alternative to polishing aluminum castings that we machine and polish Manufacturing and Related Processes 9
Marc Digital Universe - Wikipedia alternative aims to be 'PBS of the Web' After Work and Weekend Discussion Topics 1
Claes Gefvenberg What about alternative fuels? Coffee Break and Water Cooler Discussions 74
R ROHS and Prop 65 regulated materials: Alternative to the mdsystems database? RoHS, REACH, ELV, IMDS and Restricted Substances 13
Marc Outlook and Viri - An Alternative After Work and Weekend Discussion Topics 0
G Unbiased Estimators for Sigma? Is 's' an alternative to RBar/d2? Statistical Analysis Tools, Techniques and SPC 7
M Sample size of SQRT(n)+1 an alternative to AQL? AQL - Acceptable Quality Level 2
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
Sidney Vianna Are the Accreditation Bodies doing their job? Keeping CB's accountable Registrars and Notified Bodies 0
S Employee Training Matrix - Keeping track of employee training on various SOPs ISO 13485:2016 - Medical Device Quality Management Systems 4
M Keeping up with "State-of-the-Art" & updated Standards EU Medical Device Regulations 11
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
S Corporate Quality Manager keeping me out of the Management Review Meeting Management Review Meetings and related Processes 28
S Is not keeping inspection record an ISO 9001 nonconformity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K Keeping the test samples in after market nlight alloy wheel production Manufacturing and Related Processes 2
A What is the definition of Installation that requires Record Keeping vs Set-up 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Implementing ISO 3834-2 - Keeping the organization informed Other ISO and International Standards and European Regulations 3
L Keeping current on new/revised MEDDEVs EU Medical Device Regulations 8
S Requirements for keeping Records in Electronic Format Records and Data - Quality, Legal and Other Evidence 15
D Keeping Same Medical Device Name but Changing Classification Medical Information Technology, Medical Software and Health Informatics 3
M Keeping Packaging Material and Photographs in Sync with Inventory Manufacturing and Related Processes 5

Similar threads

Top Bottom