Additional Controls for processing the raw data on different computers (processing system)

v9991

Trusted Information Resource
#1
its conventional and general practice to process the data on the same instrument where the data is generated;

generally for client-server or network systems the data is hosted on central computer and the client systems access the same data from server; thus avoiding the technical problems; however, in this case, instrument system has capability of acquiring data + processing; and processing system is intended for processing alone; and both will be operational in the lab.

what are the additional controls required to be put in place for processing the data on a different system; (i.e., data generated on instrument-computer - and data processed and reported from different computer)


thank you for your thoughts and guidance.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I would think this should be covered in your validation work. A conservative approach would be to validate on each system in use. You might be able to make a case for similarity of systems (thus not having an effect on the processing) but it may be a hard sell. A practical approach might be to fully validate on one system and do partial validations on the other systems.
 

v9991

Trusted Information Resource
#3
I would think this should be covered in your validation work. A conservative approach would be to validate on each system in use. You might be able to make a case for similarity of systems (thus not having an effect on the processing) but it may be a hard sell. A practical approach might be to fully validate on one system and do partial validations on the other systems.
we do have same approach ;
so, having the 1st system with instrument to analyse (acquire data); and using 2nd (duly validated) system to process the data is acceptable.:)
 

v9991

Trusted Information Resource
#5
Should be, as long as you provide the rationale for why you believe it's acceptable.
So., apart from validation... Are tgere any otger criteria to be cinsidered.


We have controls and reconciliation yo ensure that there is no redundancy/duplication in processing data
 

yodon

Staff member
Super Moderator
#6
Without being more intimately familiar with your system, I can't think of anything. As with pretty much everything, it's all about risk. If you've done due diligence to ensure the operations are not compromised, you should be in good shape.
 
Thread starter Similar threads Forum Replies Date
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
J CE Certificate and additional processing EU Medical Device Regulations 4
dgrainger Informational Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 EU Medical Device Regulations 1
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
K Letter to file vs Special 510 for additional accessory in orthopaedic kit Other US Medical Device Regulations 1
W FAIR to AS9102 additional documentation Document Control Systems, Procedures, Forms and Templates 5
C Additional Training for CCT (Certified Calibration Technician) Recertification Training - Internal, External, Online and Distance Learning 5
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
Q Additional KPI to Top Management beside Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Risk Management - Additional Process in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Changes in MDSAP regarding to CMDCAS - Are there any new additional requirements? Canada Medical Device Regulations 1
L How document an additional software of my main device software?? IEC 62304 - Medical Device Software Life Cycle Processes 3
B Additional requirements for selling Class I Medical Device in Poland EU Medical Device Regulations 3
A Special Characteristics -> Any specific additional requirements to be met? IATF 16949 - Automotive Quality Systems Standard 7
J Example of additional Audits of Remote Supporting Functions IATF 16949 - Automotive Quality Systems Standard 2
F Additional Isolation Required? Doppler Probe Desktop Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
B Airbus & Boeing Standard and Additional Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
Z Getting Charged for AS9104/1 Additional Audit Time General Auditing Discussions 6
C AS 9102 Form 0 "Additional Information for High Risk Characteristics" AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
M Additional Procedures required for QA Department Document Control Systems, Procedures, Forms and Templates 10
P Does a 'recommended' additional Audit need to be conducted? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
A Additional Control Measures for Outsourced Processes under ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P ISO13485 Clause 7.2.1 (d) Additional Requirements - Need advise ISO 13485:2016 - Medical Device Quality Management Systems 2
G MDLA - Extensions allowed for 60 day Request for Additional Information? Canada Medical Device Regulations 4
G Additional Intended Use Predicate 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Shipping Additional Product ("Bundle") with a Class 2 Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B CMDCAS versus ISO 13485 - What are the additional requirements Canada Medical Device Regulations 21
A TS 16949 5.6.2.1 - Input to Management Review - Additional Management Review Meetings and related Processes 7
B Additional Handset added to System - Additional 510(k) Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Adding an additional site to our current TS 16949 registration scope IATF 16949 - Automotive Quality Systems Standard 5
M Refurbishing a Medical Device - Any additional information needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P CMDCAS Checklist with the additional requirements for Health Canada Canada Medical Device Regulations 4
B Additional site to be included in TS Cert. (Common owners & some functions) IATF 16949 - Automotive Quality Systems Standard 5
J Restructuring and Additional Responsibilities - Need New Quality Title Quality Manager and Management Related Issues 15
C Allowance for Slip Fit - Additional Allowance applied to GO NO GO Plug Gage General Measurement Device and Calibration Topics 26
Govind Additional discount on certification fee Professional Certifications and Degrees 4
S EC Official Journal Harmonized Standards - Additional requirements? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Number of copies for an FDA additional information request? ISO 13485:2016 - Medical Device Quality Management Systems 3
J RoHS Compliance - Steel - Customer wants additional samples tested RoHS, REACH, ELV, IMDS and Restricted Substances 32
G Sample Report to justify additional Document Control workforce Document Control Systems, Procedures, Forms and Templates 3
W Additional Regulatory Requirements for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
K Lead Internal Auditor Training - Does the lead auditor require additional training? Internal Auditing 6
H Additional sources for ASQ CQT exam sample questions Professional Certifications and Degrees 6
A EN 9100 - interpretation of additional requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
P Unreasonable FMEA request? Customer requests additional Steps in our FMEA FMEA and Control Plans 5
Y New Japanese EMC/electrical safety standards - Additional product testing required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Additional Calibration needed for C-Frame Rockwell Hardness Tester? General Measurement Device and Calibration Topics 2
H CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audits? Canada Medical Device Regulations 22
M 7.2.1 (d) - "Any additional requirements determined by the organisation" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
J ISO 9001:2000 - Transition Audit time? A full additional audit day will be required Registrars and Notified Bodies 8
Similar threads


















































Top Bottom