Treatment system data analysis - Subject to CFR part 11? Entire system?

M

mbeuget

#1
Hello everyone,


I am engineer in computer science and I have to build a system that have to be compliant with CFR part 11. But it is hard to me to understand and interpret every point of the CFR, and if I am subject to certain point.

To explain : my company has developped some really efficient algorithms in signal processing for biological data, so they want a SaaS plateforme to automate the treatment and generate automatically some reports that are interessing for their client : biologist and labs.

So we do not produce any data, clients upload their files, choose treatments and visualize/download the result. We only proccess records and generate graphs, etc.

And I have to make the plateform compliant with CFR part 11, so I have some questions :

- If a client is not compliant with CFR part 11, predicate rules, then their records aren't compliant too, so in this case I haven't to be compliant too ?

- If a client is compliant with CFR part 11, and their records respect predicate rules, then if he uploads a compliant record, what I have exactly to ensure ?

-> for the record integrity I compute sha-512 both in client side and server side, then I compare the two, if equal, then it hasn't been altered by the upload.

-> for the record storage/access control/audit trail I store everything in a MongoDB database, and it is impossible to alter the record : the only permitted operation is download the file through the client account, the administrator cannot himself delete the record. (and I store the sha-512 also). My plateform logs everything, my database logs every access, my system logs also every system operation, and I am able to export it.

-> of course the plateform is secured.

Open source databases like MongoDB or MySQL is considered reliable by the FDA, isn't it ?

Am I subject to electronic signatures ??
-> If a record is not compliant then we haven't the goal to make it compliant, it is a client side problem and there are no signatures.
-> If a record is compliant then it has probably been submitted to the Agency so it has a signature attached ?

We don't need to register to FDA if we don't want to submit any file ?

For a compliant record do I need to let the FDA access the file through the plateform ? Or FDA access the file through the client system ?

The 'report' we generate are they subject to CFR part 11 ? It is the result of some treatments, it should not be submitted to the agency as if the record is compliant ?


I'm sorry but I'm a bit lost with all these questions, I think I am compliant with the part B but I don't know what is my scope exactly ...


Thanks to help me !!
 
Elsmar Forum Sponsor

JJ_FDA

Involved In Discussions
#2
If your client's records are subject to predicate rules, then your system must be able to respect the record-keeping requirements of predicate rules and the Part. It's really up to the client to make this determination; I'd think your role is to enable them to fulfill the requirements of part 11 (audit trails, e-signature functionality, access to their records by auditors, access and role-based controls, validatable by the client, etc. etc.).

In addition to Part 11 itself, have you taken a look at the guidance and articles like this? Are you familiar with validation frameworks like GAMP?
 
M

mbeuget

#3
Thanks for your answer.

When you say "If your client's records are subject to predicate rules, then your system must be able to respect the record-keeping requirements of predicate rules and the Part",
does that mean that if the record is subject to predicate rules and Part 11, all I have to do is to :
1) ensure that the record hasn't been altered during the upload (sha functions is usefull there);
2) ensure that the record has been correctly "recorded" in the database (sha functions usefull too);
3) periodically check that the record hasn't been altered "by the time" (sha functions too).
4) ensure the access control and general security ?

The electronic signature is inside the file, right ? So if SHA-512 hasn't change, the file hasn't changed and the signature too.

In my case we produce others document relying on the record but we never modify the original record. If we ensure that the transfert is correct, the storage too, and that we have a strong access control and security on the plateform, we should be compliant ?
The treatments and results of treatment aren't subject to part 11, are they ? Or they meet others requirements to ensure that the algorithms treat correctly the record, aren't they ?

I don't understand very well when you say : "I'd think your role is to enable them to fulfill the requirements of part 11 ", our goal is to treat records, and display the results of automated or supervised treatments, not to help the client to be compliant with CFR. We just want that if the record is cfr compliant, then we don't make it "uncompliant".


I have a last question, our client will most likely use some xCELLigence RTCA Instruments with its software, do you know if these kind of instruments are compliant ?
(can't post the link ...)


I'll read your links in detail, unfortunately we haven't the GAMP 5 ...

thanks
 

JJ_FDA

Involved In Discussions
#4
I have no experience with xCELLigence XTRA instruments, so I do not know if it is capable of compliance, but I'd like to point out a subtle distinction: equipment, instruments, or computer systems in and of themselves cannot be compliant to Part 11, but their implementations can be validated as compliant. In other words, they can be capable of compliance, but how they are being used determines the state of compliance.

What this means is that you cannot buy something that is capable of Part 11 compliance, use it right away, and say, presto!, I am Part 11 compliant.

With SaaS, this means that the system as a whole needs to be considered: the part that you are developing and that you are selling to the client, and the part at the client's end that interacts with your software (e.g., Web browser, I imagine, and whatever data storage they use at their end). All this, considered as one system, needs to be validated as Part 11 compliant.

For example, if they download some data processed by your SaaS, and then that instance of the data is sent of as part of their application to FDA, the integrity of that downloaded data probably needs to be assured. However, you have no control over what the client does with the data once downloaded. It could be stored on a shared drive with no access control, breaking one of the requirements of Part 11. So even if your SaaS piece is capable of Part 11 compliance, the system as a whole is not.

This is why I say your role is to enable them to fulfill the requirements of the Part for the SaaS piece of the system, there's no way that you can sell them something that is immediately compliant out of the box.

This is also sort of why I pointed you into the direction of GAMP (which is not a requirement, but only one way of looking at validation).

As for records, you need to make sure that the original entry and any subsequent changes to the entries can be recreated (audit trail functionality) in terms of what changed, who changed it, and when it was changed. The requirements are spelled out in the Guidance. If you're familiar with version control software such as SVN, it's sort of the same principle.

Requirements for e-sigs are also detailed in the Guidance.

Note also the record keeping requirements that the Part may impose on you, the software developer.
 
M

mbeuget

#5
Ok, thanks it seems more clear to me.

And do you know what could be the form of an electronic signature ? I know you need to validate a certificate so you possess a private key, and you can generate a signature with that and attach it to your document.

But what is it exactly ( generally for biological data like a big xls document ) ? a picture ? a token ? encrypted data ? watermarking ? (didn't find it in the guidance)

If I understand I may have to extract the signature of a client from a document he uploaded ( once I'm sure it's not altered with the upload ) and then paste it on documents we generate, and keep them ready for inspection by the FDA auditor, if the client want to submit it to FDA ?

So I have to create a special account for the FDA auditors ?

And last question, is the treatment in itself important for the FDA, if the results we generate are submitted to FDA for inspection ? The algorithms are really the intellectual property of my company there is no way we send them to the FDA, only the results.

Thanks
 

c.mitch

Quite Involved in Discussions
#6
Hi,
Electronic signatures don't have to be rocket science like biometrics or complex certificate systems.
An electronic signature can be a login + password. Then when a user signs a document, he/she enters his password.
A few set of basic functions need to be implemented to ensure a minimum of security and to avoid impersonation:
-one login per user
-disallow weak passwords
-password expire after a configurable number of days
-password needs to be typed when user logs in and for each document he has to sign (acceptable though for a group of documents at once)
-application disconnects after configurable idle time
-audit trail of logins logouts, password changes, failed logins attempts, documetd signatures, ...

Regarding the FDA, you may have a special account for auditors, to let them see the audit trail. But I don't think your software will be any data to the FDA for inspection. Hence FDA inspections are in the client premises, not remote.
 

JJ_FDA

Involved In Discussions
#7
As long as your implementation of electronic signatures satisfies the criteria of Subpart C of the regulations, FDA will not worry too much about how you implement e-sigs.

I would go back to the predicate rules as well to learn about the goals and purposes of electronic signature to be sure that your implementation fits the bill.

As for accounts, definitely plan on creating read-only accounts for FDA and other people that can see both the data, and the audit trail for the data. Make sure that they can be jailed to only the data being audited (i.e. they are auditing client A, so they should not be able to see data that belongs to client B).
 
Thread starter Similar threads Forum Replies Date
N EtO Sterilization Process Waste Treatment System Other Medical Device Related Standards 1
R MSA studies for Heat Treatment Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
K Please help identify appropriate statistical treatment Statistical Analysis Tools, Techniques and SPC 13
1 ISO Registrar with waste water treatment experience Registrars and Notified Bodies 1
J GLP Animal Study - Change number of treatment sites Other US Medical Device Regulations 2
Q Risk Analysis - Same Risk Treatment for Context and Interested Parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Nonconformance Raw Material Treatment in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M API 6D-2014 24th Ed. Pto 6.10 - Heat Treatment Equipment Qualifications Oil and Gas Industry Standards and Regulations 4
E RF Energy Treatment Devices for CFDA Registration China Medical Device Regulations 1
A Is Risk Identification and Treatment a Process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
S Heat Treatment - Soaking time interpretation Manufacturing and Related Processes 5
elkel CQI 9 (Heat Treatment) Assessment Requirements - Company and Customer Requirements Customer and Company Specific Requirements 1
S Paperless Temperature Recorder for Temperature Surveys on Heat Treatment Ovens General Measurement Device and Calibration Topics 6
G SPC in Heat Treatment Workshop Statistical Analysis Tools, Techniques and SPC 2
B FDA Product Classification - Self Treatment Software Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q 8.3 Control of NC product and 7.4.3 Verif. of purchased product, same treatment? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A NADCAP AC 7101/03 Heat Treatment Process Acceptance Tests AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Risk Register, Risk Analysis and Risk Response/Treatment IEC 27001 - Information Security Management Systems (ISMS) 5
A Aesthetic Treatment Medical Devices in Japan Japan Medical Device Regulations 2
S Quality Objectives for Aerospace Chemical Conversion & other Surface Treatment Plant AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R CQI-9 Heat Treatment Process Table C question IATF 16949 - Automotive Quality Systems Standard 3
K Heat Treatment (Softening) on Cast Iron before it can be drilled to form Thread? Manufacturing and Related Processes 4
N Dental Treatment Unit (aka Dentist's Chair) requirements EU Medical Device Regulations 7
P Risk Assessment and Treatment Plan for IT Company - sample wanted IEC 27001 - Information Security Management Systems (ISMS) 4
W What can be Root Cause Analysis Methodology - Heat Treatment of Carbon-based Products Problem Solving, Root Cause Fault and Failure Analysis 5
W Calculating Minimum Heat Treatment Quench Bath Size Manufacturing and Related Processes 2
S AS9100 REV B Sampling Requirements - Heat Treatment of Large Cylinders AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T Heat Treatment Process FMEA example wanted FMEA and Control Plans 5
T Use of Chlorine Dioxide for Water Treatment Hospitals, Clinics & other Health Care Providers 4
somashekar Information sharing: Week 27, 2010 (HEAT TREATMENT) The Reading Room 3
P Help on Treatment of Points Outside of Control Limits Statistical Analysis Tools, Techniques and SPC 4
A Ovality and Flatness generated after Heat Treatment of Rolled Rings Manufacturing and Related Processes 3
S Benchmarking of Capability, Accuracy and Stability analyses - In Heat treatment Capability, Accuracy and Stability - Processes, Machines, etc. 3
T Accounting Treatment for RMA Spares Inventory Misc. Quality Assurance and Business Systems Related Topics 1
C ID (Inside Diameter) Threads Shrinking due to Heat Treatment and Weld Manufacturing and Related Processes 11
N Lot Capability - Forging -> CNC Machining -> Heat treatment -> Packaging Statistical Analysis Tools, Techniques and SPC 3
A Austempering Heat Treatment Machine - Problem regarding Decarb (less carbon) Manufacturing and Related Processes 16
B Is Heat Treatment for Metal a Special Process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 87
M ISO14001 nonconformance - no proper treatment of wastewater prior to discharge ISO 14001:2015 Specific Discussions 6
J Heat treatment inspection and Process capability index Cpk Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
O CQI-9 #1.9 - Heat Treatment - Management shall review the furnace monitoring systems IATF 16949 - Automotive Quality Systems Standard 3
E Service or Production? Water treatment, monitoring, and testing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V Auditing Treatment, Storage and Disposal Facilities - Non-Visit Audit ISO 14001:2015 Specific Discussions 20
P AS 9102 requirement for parts that need further treatment such as Anodizing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B Design of Experiment (DOE) for Heat Treatment Process Statistical Analysis Tools, Techniques and SPC 4
S Design for Compact Wastewater Treatment Plant to Cater to a Healthcare Facility Design and Development of Products and Processes 6
K CQI-9 - Heat Treatment standard for Automotive Sector IATF 16949 - Automotive Quality Systems Standard 1
A Heat Treatment Validation - Titanium (6Al 4V) for 2 hours @ 700 Deg C Manufacturing and Related Processes 6
O Nonconformance Treatment Diagnose - Estimating how many nonconformances neglected Nonconformance and Corrective Action 1
A The Silent Treatment Funny Stuff - Jokes and Humour 0

Similar threads

Top Bottom