Legal requirement for archiving technical manuals

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  • Legal requirement for archiving technical manuals
  • peterfile
    Member

    Do you mean manuals for equipment which you have provided to customers?

    What sort of equipment is it? What sort of manuals are they? (e.g. do the manuals have any sort of calibration data, signatures etc in them?) Do you provide any service to your customers after the sale (e.g. is there anything in the contract about maintenance, support etc?)

    Generally, you’d be wanting to keep manuals etc (in one way, shape or form) for at least the statutory period of limitation (6 years) in case you end up in a dispute with your customer.

    Usually your obilgations contractually are simply to supply the customer with manuals, however, where equipment is particularly high value or specialised, it’s not entirely uncommon to have an additional requirement that the manufacturer is able to “make available” a copy of the manual for a set period of time (often 6 or 12 years, or longer if the equipment warrants it and the contract is negotiated in that way).

    The other issue you have, aside from contractual or statutory obligations, is customer service. if your equipment lasts for 25 years on average, it would seem prudent to hang on to copies of user manuals for at least that long.

    As for the method of storage, again it will depend on what the contract says, however if there is no obligation to store an original hard copy (which I would be surprised if there was, particularly if its your contract/T&Cs which form the basis of sale!), I can’t see why an electronic reproduction would be an issue, even for the courts in the event of a dispute. One thing we use is the idea of a data “custodian”, an independent company which will verify and securely store electronic data for 25 years. However, this is primarily so that both parties to our contracts know that the data will remain unamended.

    irelanst
    Member

    In all of the companies I have worked in recently the operating manual has been part of the technical file (I’m assuming your products are CE marked). The technical files have all been electronic and when audited (ISO and FDA audits) have been acceptable.

    Premier Icon wwaswas
    Subscriber

    My wife needs access to copies of her payslips from 10 years ago due to a pensions dispute.

    The employer kept copies on cd but only had one pc that could read the cd’s. A bright spark in IT decided to throw the pc out and replace it with a ‘nice new one’.

    So now she has no access to any payslips other than (and I kid you not) the few on a sheet of microfiche that the bloke ‘found in the back of my drawer a week or two back and kept out of interest’.

    So, by al means keep an electronic copy but bear in mind that in 20 years time it maybe difficult to access whereas a piece of paper is likely to be human readable for at least that long if stored sensibly.

    peterfile
    Member

    In all of the companies I have worked in recently the operating manual has been part of the technical file (I’m assuming your products are CE marked). The technical files have all been electronic and when audited (ISO and FDA audits) have been acceptable.

    Good point. You don’t mention where the rest of your tech data is stored, is it possible to kill two birds with one stone and store them together?

    Premier Icon Drac
    Subscriber

    If you can keep patient records electronically and legally for 21 years then I can’t see it being a problem for a piece of machinery.

    The employer kept copies on cd but only had one pc that could read the cd’s. A bright spark in IT decided to throw the pc out and replace it with a ‘nice new one’.

    Sounds like a cop out to me.

    peterfile
    Member

    If you can keep patient records electronically and legally for 21 years then I can’t see it being a problem for a piece of machinery.

    Patients don’t really make a habit of neogtiating specific terms relating to the storage of their data though 🙂

    It’s not much of an issue from a statutory perspective, but contracts can be pretty prescriptive about stuff like this. Often, the more significant in terms of cost and complexity of the equipment, the more complex the terms which sit along side it. That said, I would still be surprised to see a provision which required you to keep an original hard copy of a user manual, unless there was a specific reason for it (i.e. manuscript calibration data which need to be signed off)

    Don’t get me started on BIM (try sorting out a user manual for a £600m building) 🙁

    Premier Icon Drac
    Subscriber

    Patients don’t really make a habit of neogtiating specific terms relating to the storage of their data though

    No but governing bodies and legal parties do.

    Our company currently spends a few grand a year archiving hard copies of our operation and maintenance manuals.

    Is this a legal requirement or could we PDF everyhing and stow it on a server? Surely if we are able to completely reproduce a manual if, for example a customer orders a new copy, that is sufficient?

    Your advice and any links to guidance very much appreciated

    peterfile
    Member

    No but governing bodies and legal parties do.

    Aye, my point was that just because something isn’t a legal requirement under statute or guidance etc, doesn’t stop one party from requiring it in a contract. You could agree to have a dancing midget deliver a bunch of flowers with your user manual if you so desired.

    irelanst
    Member

    is it possible to kill two birds with one stone and store them together?

    Yes, that’s what normally happens. The documents are converted to PDF or TIFF and uploaded to a server.

    The documents have been managed using using various tools, Agile in the last 2 places and Teamcenter at the moment.

    Our products are specialised: bespoke pharmaceutical manufacturing equipment. Also fairly high value £250k-£1m. It has a circa 25 year operating lifecycle.

    Peterfile – very useful response. Many thanks. I have a plan.

    Premier Icon geoffj
    Subscriber

    I have a plan.

    * hopes it involves dancing midgets with flowers.

    peterfile
    Member

    Our products are specialised: bespoke pharmaceutical manufacturing equipment.

    As well as the usual statutory requirements and any which may be in your contracts with customers – check the regulatory requirements too (e.g. anything which might apply to your industry specifically).

    Premier Icon footflaps
    Subscriber

    With the rate of change of technology and media it would be prudent to store hard copies on paper as that will be machine readable for decades. Anything else is much less clear e.g. BBC Micro floppy drive reader anyone or laserdisc reader? Even the Space Shuttle had problems sourcing floppy discs http://news.bbc.co.uk/1/hi/sci/tech/1985138.stm

    antigee
    Member

    did stuff on this with FAA and CAA (US and UK air authoriries) we had to demonstrate that we were competent to maintain and manage electronic documents and that we had adequate resources to manage migration to future systems and to maintain readability if technical obsolence became a problem – these were documents relating to batch traceability of materials/engineered components for recalls – think minimum required to maintain was 20years

    poly
    Member

    Our company currently spends a few grand a year archiving hard copies of our operation and maintenance manuals.

    Is this a legal requirement or could we PDF everyhing and stow it on a server? Surely if we are able to completely reproduce a manual if, for example a customer orders a new copy, that is sufficient?

    Your advice and any links to guidance very much appreciated

    Our products are specialised: bespoke pharmaceutical manufacturing equipment. Also fairly high value £250k-£1m. It has a circa 25 year operating lifecycle.

    Peterfile – very useful response. Many thanks. I have a plan.

    Are your products FDA regulated? Or do your customers stipulate in a Technical Quality Agreement the standards you must adhere to, retention periods etc.

    In principle you should be able to store your records electronically even if you or your customers are FDA regulated, but someone in your company needs to know what they are doing. If you are scanning files for archiving then you’ll be expected to have a documented procedure and records that prove that what you scanned represents the original. You will need to demonstrate how access to the archive is controlled (e.g. so unauthorised persons can’t accidentally delete data). You will need to have procedures in place for backing up any records and be expected to show that you have tested recovering the backups. You will need to have training records that show your staff know how to do all this and are competent. With a 25 yr cycle I would also think you need to consider future proofing, so that say every 3-5 yrs someone has to check that the file formats are not becoming obsolete and if they are converts to something better.

    Even if you / your customers are not FDA then all of the above is likely to be a sensible approach. It would be very easy to stick everything on a server and forget about it for 10 yrs then discover that its no longer accessible.

    If you have a quality person in house they will either embrace this, or more usually, tell you 100 reasons why it can’t be done. It is NOT impossible. When they tell you it can’t be done ask to see the relevant standard and have them explain where it says its not possible!

    sharkbait
    Member

    ….. Or just let us scan it for you (it’s what we do!).

    Realistically the only way forward is to scan the hard copy to PDF – the file format has been around for about 15 years and there’s nothing even vaguely as suitable on the horizon.

    Anything else is much less clear e.g. BBC Micro floppy drive reader anyone or laserdisc reader?

    To be fair these were media formats that became obsolete. Today the media might change (we used to supply everything to our clients on CD but now use USB sticks/drives) but the file format is the same. In fact we’re now starting to store scanned files in cloud storage (Amazon S3) but this is more for documents that are going accessed from our search facility.

    DS if you’re employer is archiving hard copy then they’re mad frankly. Giving your files to someone to store for you does not mean they’re safe – these places can, and do, burn down.

    If there is a worry over whether a scanned document is authentic then the PDFs can be digitally signed. This is inform anyone who opens the file whether it has been changed at all since its creation.

    Edit: Do NOT save files as Tiffs, no capability for the inclusion of colour and a 6 years old can make unseen changes to them.

    FAA and CAA are happy with PDFs (unsigned) – we’ve done loads for a company that manufactures/services engine parts.

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