FDA or CE requirements for periodic checks of data backups and retrievals

#1
Does anyone know if the FDA or CE require periodic checks of the backups and retrievals even if the company's documents are hosted in the cloud by a resptable cloud host (e.g., Amazon, etc.)? If the company handles its own backups and retrievals, it is understood that there will be periodic checks. The questions relates to using the cloud as the host.
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
I'm not aware of a specific regulatory requirement to maintain back-ups or have disaster recovery plan; however, it's up to each company to determine if having DR is an appropriate control based on the risk, but in most cases I would say it is.

For service providers like AWS, you can ascertain high confidence that they have DR in place and it's being periodically checked based on the certifications and reports AWS maintains, e.g. ISO 27000, SSAE 16, etc.
 
#3
Thanks. That is my take of this also. I wanted to know if there are any regulatory requirements as such and not just best practice in the company.
 

Mark Meer

Trusted Information Resource
#4
I'm not aware of a specific regulatory requirement to maintain back-ups or have disaster recovery plan;
FDA 21 CFR 820.180 requires backups.

"Those records stored in automated data processing systems shall be backed up."

As far as criteria, I don't know if there are any policies with respect to what inspectors expect. Given the requirement is so general ("shall be backed up"), I suspect that as long as you've considered it, and documented the means by which backups occur and are maintained, you should be fine.

In other words: documenting that Amazon maintains automated reliable backups (e.g. in your supplier approval) should be sufficient as evidence of compliance to this requirement.

MM.
 
Thread starter Similar threads Forum Replies Date
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C FDA Registration Requirements for Multiple Sites 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
K FDA Lot Code format requirements Other Medical Device and Orthopedic Related Topics 1
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
E FDA Supplier Labeling Requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
M Different websites for different markets - FDA, Health Canada or other requirements Medical Information Technology, Medical Software and Health Informatics 4
M Informational FDA Panel Recommends New Postmarket Requirements for Breast Implants Medical Device and FDA Regulations and Standards News 1
C FDA Medical Device Label Requirements - serial numbers Other US Medical Device Regulations 2
N FDA Traceability Requirements - Component lots ISO 13485:2016 - Medical Device Quality Management Systems 2
D FDA Requirements for First aid kits US Food and Drug Administration (FDA) 1
R FDA Requirements - Printing Equipment Software Validation Qualification and Validation (including 21 CFR Part 11) 1
S FDA requirements and CAPA's Qualification and Validation (including 21 CFR Part 11) 2
J FDA regulations vs. IEC 60601-1 Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
F MDSAP vs "Full" FDA Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A FDA Sub contractor Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S New clean room change submission - FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Sample of an end-use-letter for drugs according to FDA requirements US Food and Drug Administration (FDA) 2
J PMA Device - Lot # change in New ERP Software - What are the FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
T FDA Design and Development Planning Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S FDA Class I Medical Device Safety and Efficacy Data Requirements Other US Medical Device Regulations 5
I FDA Class II Medical Device Clinical Trials and and FDA IDE Requirements US Food and Drug Administration (FDA) 3
R Customer Complaint - Samples vs. Removal - FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N FDA Requirements for Animal Laboratory Testing (Harmonic Scalpel) Other US Medical Device Regulations 1
S COTS (commercial off-the-shelf) Validation FDA Requirements Software Quality Assurance 4
T Inspection Form Review And Approval - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
cscalise FDA requirements for Servicing and Refurbishment of Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 21
V Differences between ISO 13485 & FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
T Document Review And Sign Off Second Person Review - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
A Products for Design Validation - FDA Requirements US Food and Drug Administration (FDA) 3
R FDA Shelf Life Requirements for EO Surgical gown 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S Certificate of Need (CON) and FDA Requirements US Food and Drug Administration (FDA) 6
S IEC 62366 vs. FDA Human Factors Requirements Human Factors and Ergonomics in Engineering 2
T FDA Requirements - Class 1 Exempt Medical Device Recall ISO 13485:2016 - Medical Device Quality Management Systems 2
P FDA requirements for Exempted Class I Medical Devices Other US Medical Device Regulations 5
J FDA Microscope IQ (Installation Qualification) Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A FDA Blood Pressure Monitoring Equipment Measurement Requirements US Food and Drug Administration (FDA) 1
Q FDA Requirements for Contract Manufacturers and OTC products US Food and Drug Administration (FDA) 4
J Exporting Add-On for Medical Devices to the US - FDA Requirements Other Medical Device Related Standards 3
A FDA 510(k) Payment requirements for a Small Company US Food and Drug Administration (FDA) 3
K UDI (Unique Device Identification) requirements of US FDA US Food and Drug Administration (FDA) 4
pbojsen FDA Medical Device Materials Requirements US Food and Drug Administration (FDA) 4
I FDA Cleanroom requirements for class II in vitro medical devices US Food and Drug Administration (FDA) 1
S FDA Requirements about a Notified Body Change US Food and Drug Administration (FDA) 2
S Are there any new FDA requirements on Record Retention ? US Food and Drug Administration (FDA) 4
M Any new or revised EU or FDA regulatory requirements for IVD diagnostics in 2013? ISO 13485:2016 - Medical Device Quality Management Systems 4
F FDA Device Labelling/Packaging Information Requirements Other US Medical Device Regulations 3

Similar threads

Top Bottom