Document management solution for young SME

[TUS 373]

I am currently consultant for a young SME, an R&D business who are developing for the pharmaceutical / medical devices markets.

I can see that they need methods to:
1. backup all information
2. manage storage of scientific measurements captured from their lab instruments
3. share filing, storage, retrieval of a variety of paper and electronic documents that they may have to preduce on demand to a regulatory body.

This may not be the end of their needs, and I have effectively highlighted some problems to them, but have no personal experience of what kind of system/software they should implement to solved this.

The company is an SME so money is tight, but better to spend some and protect all their data and share it more efficiently. At the moment, I would say a solution that can be installed on around 10 pcs networked together (equipment they already have) would do the trick. I have also recommended that they do back-ups rotated around 3 removable hard drives, with one being kept off site, and another in a fire proof safe.

Anyone suggest a suitable and economic solution to this kind of scenario that I can start looking into on their behalf please?

[roadsweeper]

Have you considered MS SharePoint? It's not the most powerful document management solution out there but it sounds like it would be fine for their needs and it integrates with MS Office quite nicely.

[aldi]

1) The removable hard disk - have a look at IOMega REV drives, they're basically removable HDD cartridges but the drive works well with all the common backup software (supplied software is no good). I've found them to be very reliable. If they're working with valuable commercial secrets maybe look at something that encrypts?

2) Dunno, I ran round fixing stuff at one of the big pharma-co's for a few years and they used a few different document managment systems, different ones for commercial, engineering and scientific. Some in-house and some bought in but they'l be a bit heavyweight for your needs I think... The point is it was more for the versioning, access control and audit-trail facilities than any other reason ISTR, tie-ing in with 3.

3) Regulatory bodies - what will they want to see? Are they going to be FDA inspected? Those guys are massively anal. ISTR the 21 CFR 11 requirements were pretty important, wasnt really my area though so I dont't know if it affects you TBH... not very helpful I know But basically whatever regulators they come under might well have an 'approved list', and if they might be trying for approval in the future they will want to start off with something that's compliant now.

HTH

Neil

>> Edited by aldi on Friday 21st October 18:28

[TUS 373]

Thanks guys. I'm not a regulatory expert, but the markets they are going for are headed up by the US, so FDA compliance is something that really needs to be considered,

Sorry, don't understand acronym "ISTR", what's that?

Will look at MS Sharepoint, it may be something to at least get them into the right way of thinking.

[aldi]

Sorry, I Seem To Remember

[jimothy]

Things like 21CFR part 11 are a right pain in the arse. If stuff like this is important, it's worth going to an expert. I can put you in touch with some friends of mine who are a pharmaceutical IT consultancy. Won't be cheap for their expertise, but it;d be right. One of their bods is well up on 21CFR/11

Mail me through my profile if you want more info.