Electronic Laboratory Notebooks - ISO 13485 Regulations and Requirements

[blah1]

Hi,

I am new to medical devices and I have some questions concerning the use of lab notebooks.
Has anyone here used electronic lab notebooks in their company and been through an iso13485 audit? Were there any problems or issues?

Also, what would be the implications for electronic lab notebooks and its disadvantage/advantages over hardcopy lab notebooks in protecting against IP?

Any help is appreciated!

 

[Marc]

A quick "Bump". My Thanks in advance to anyone who can help with this one.

I'm not an ISO 13485 specialist by any means, but I doubt that it would be a problem in an audit if the electronic notebook was compliant with ISO 13485 electronic document requirements.

As to protecting against IP (intellectual property) theft or such, I would think it would be a moot issue unless you hook it up to a network.

 

[pkost]

Off topic slightly: the FDA require computer systems storing records to be validated (21 CFR 11). The requirement is enforced and there have been a few warning letters issued on the subject.

The requirement in ISO is not as explicit but you do still have to control your records i.e. "A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records."

From comments I have heard (no personal experieince), NB's don't have sufficient training/experience to handle electronic records appropriately and so a simple backup plan will commonly satisfy the auditor. I would imagine though that at some point they will see the risk of electronic records and start to head more towards the FDA approach.

with regards to protecting IP; the same issues arise as with hardcopy, if someone is determined they will steal/copy. You could password protect, but someone has to have access and you have to trust them. You have to trust all your employees!

 

[yodon]

Good feedback so far.

What aspect of complying with the regulation or the standard would you be showing with the electronic lab notebook? If you're saying those are your design documents, you might be in a less than defensible position since design docs are expected to be reviewed and approved.

If strictly used for documenting IP then you probably just need to consider Good Documentation Practices. Consider comparable issues with paper notebooks. If there's no linkage to date and author then it might not stand up well.

So generally speaking, determine what the 'paper' equivalent would be. How would you manage that? What is important? Translate those aspects to electronic media and control and you probably have a defensible case. If you're truly using them as electronic records (supporting a predicate rule) or electronic signatures are used then you need to consider the aspects of 21 CFR Part 11 (FDA) / Annex 11 (EU).

 

[v9991]

Has anyone here used electronic lab notebooks in their company and been through an iso13485 audit? Were there any problems or issues?

this is not exactly issues from ISO-audits, but info/knowledge based on interactions with regulatory auditors & specialists/consultants...
Apart from Part-11, validation requirements; the focus would be on managing/maintaingthe tool itself. (viz., training, authorizations, change control (patch/upgrades), audit trail, timelines )

Also, what would be the implications for electronic lab notebooks and its disadvantage/advantages over hardcopy lab notebooks in protecting against IP?

very boradly speaking,
I see that as an advantage because, this will drive the procedures of "verification/witness" signatures; + compliance to online documentation expectations. (no more possibilities of recording from memory recollect/rememberance..even if it is done, it would mean you lost advantage of date/time; or authenticity) (this would be taken opposite view from pure operations/scientist stand point..who might tend to see this as an constraint/hurdle )

 

[Ajit Basrur]

Hi,

I am new to medical devices and I have some questions concerning the use of lab notebooks.
Has anyone here used electronic lab notebooks in their company and been through an iso13485 audit? Were there any problems or issues?

Also, what would be the implications for electronic lab notebooks and its disadvantage/advantages over hardcopy lab notebooks in protecting against IP?

Any help is appreciated!

I feel you should be comfortable with ISO 13485 but could be more challenge with ISO 17025. Refer "Regulatory and Legal Aspects" from Electronic_lab_notebook.

The main advantage of Electronic Laboratory Notebooks (or ELN) is that it could be stored electronically for longer periods and occupies less storage space.

 

[somashekar]

1. Records are a special type of document (from 4.2.3 of ISO13485)
2. The documentation can be in any form or type of medium (from 4.2.1 Note 2 of ISO13485)
3. The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements. (from 4.2.4 of ISO13485)

If the ELN can meet the point 3. above and you can demostrate it as required in 6.3 (Infrastructure) you are all OK ....

Under 6.3 note this :
The organization shall establish documented requirements for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality.
Records of such maintenance shall be maintained (see 4.2.4).

So records again are essential to show that ELN is good for you.

See Wiki link above from Ajit for more support on the use of ELN

 

[v9991]

Also, what would be the implications for electronic lab notebooks and its disadvantage/advantages over hardcopy lab notebooks in protecting against IP?
Any help is appreciated!

2nd part of my earlier response was with a assumption that IP = intellectual property; Hope that was correct.