Comments for Rammell Consulting Ltd.

Comment on Is it OK to “manipulate” PDFs to improve records management? by Jim Kent

Jim Kent — Mon, 23 Jan 2012 12:29:23 +0000

Assuming one is not banned from such concatenation (the implication I saw attached to ONS data 4 – 5 yrs ago) why not attach its own simple provenance URL individually to each document in the concatenation? – standard scientific research practice (or at least it used to be).
With a signature, use the (again perhaps old) practice of signing just an Executive Summary (if such exists) or include the phrase “this is an interim report” and is “signed without fine detail or implications checked”. An alternative might be “application of statements in this report may give rise to unintended consequences; the user carries the responsibility to check”, that is, use the software OEM approach beloved of MS etc

The latter seems to be appropriate for much recent Government legislation!

Regards,
Jim

Comment on eTMF Vendors – Who Has the Largest Market Share? by rammellel

rammellel — Thu, 19 Jan 2012 14:57:16 +0000

Hi Chris,

Unfortunately, no responses have been posted. I will post any responses if I get any!!

Kind regards,
Eldin.

Comment on eTMF Vendors – Who Has the Largest Market Share? by Chris Cowger

Chris Cowger — Sun, 11 Dec 2011 16:03:23 +0000

Hello:
I had asked the question “Who has the largest market share” of eTMF solutions. I appreciate you posting the question and was wondering if you have gotten an answer, yet.
Thanks
Chris Cowger

Comment on Are Copies as Acceptable as Original Documents? by rammellel

rammellel — Mon, 28 Nov 2011 19:50:12 +0000

Thank you for the comment Jan. It would be very useful to have the specific reference/citation that prohibits the digitization of paper records for archival purposes so that this can be followed up with the EMA and by the DIA Working Group.

Comment on Are Copies as Acceptable as Original Documents? by Quality Business Support

Quality Business Support — Sat, 26 Nov 2011 11:44:43 +0000

I would be very interested in the framework and the discussion during the DIA. In the Netherlands the DARQA (www.darqa.org) is adressing this issue with the Dutch inspectorate. The inspectorate considers that the law on archiving applicable to govermental archives also applies to clinical studies. This legislation does not allow substitution.

Comment on Why Good Records Management Is Key by Pauline Patel

Pauline Patel — Fri, 07 Oct 2011 13:38:01 +0000

Good stuff from Eldin & Karen as usual!

Comment on Electronic Trial Master Files (eTMF) by Sarah Hitching

Sarah Hitching — Wed, 21 Sep 2011 10:25:40 +0000

Chiltern SAFE – Chiltern International

Comment on PDF/A Standard Now Uses PDF v1.7 by ISO 9000

ISO 9000 — Thu, 04 Aug 2011 13:17:54 +0000

I can see that you are putting a lot of time and effort into your post.I love every single piece of information you post here.Will be back often to read more updates! iso 9000