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- TMF Reference Model Gains Momentum wp.me/p1ezQs-5v 3 weeks ago
- Do You Destroy Records Securely? wp.me/p1ezQs-5r 4 weeks ago
- Will ePub or HTML5 Be The New Standard for Electronic Records? wp.me/p1ezQs-5p 1 month ago
- DIA EDM Corner Has Moved wp.me/p1ezQs-5n 1 month ago
- GCP Records Management - How Are We Doing in Canada? wp.me/p1ezQs-5l 1 month ago
Author Archives: rammellel
Certification by a qualified person and batch release – Consultation
A concept paper on revising Annex 16 of the guide to good manufacturing practice: certification by a QP and batch release is currently open for consultation until 31/01/2012 using the following link to the EMA website: http://bit.ly/yTocBW The concept paper … Continue reading
Posted in Regulations
Tagged annex 16, GLP, gmp guidelines, good manufacturing practice, QP
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Are Copies as Acceptable as Original Documents?
This is a question that I seem to be hearing with increasing frequency! I think the reason for this is that an increasing number of companies and organizations are introducing electronic document management systems (EDMS). Where there are hard-copy records … Continue reading
Posted in Compliance, e-records, Litigation, Records management practice, TMF
2 Comments
MHRA Opens Public Consultation on Review of UK Medicines Legislation
On 25th October, the MHRA opened a consultation period of 12 weeks for their review and consolidation of UK legislation pertinent to manufacture and use of medicines. Many requirements relating to the creation, management and retention of medical records are … Continue reading
Posted in Regulations, TMF
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eTMF Vendors – Who Has the Largest Market Share?
This is a question just sent through to us….. which vendor has the largest market share of the eTMF solution vendors? I guess the answer will depend on whether we’re talking about most client licenses/seats or highest volume of sales and whether … Continue reading
Posted in e-records, TMF
2 Comments
Fire at Iron Mountain Facility in Aprilia, Italy
A large fire struck Iron Mountain’s document storage warehouse and headquarters in Aprilia, Italy late on Friday 4th November 2011. According to news reports, the entire building was enveloped in flames causing substantial damage to the building and, presumably, to … Continue reading
Posted in Document Storage
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Documentation Risk Adaptations in Clinical Trials
A paper has recently been published under the joint auspices of the UK Department of Health (DH), the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Research Council (MRC) describing risk-adapted approaches to the management of clinical trials of … Continue reading
Posted in Compliance, Records management practice, Regulations, TMF
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Why Good Records Management Is Key
Authors: Eldin Rammell & Karen Redding (Phlexglobal Ltd) The past year has seen significant consolidation of mid-size CROs, with many of them being bought or put up for sale. In particular, the top six or seven CROs seem to be … Continue reading
Posted in Records management practice, Technology, TMF
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Questions a Sponsor Should Ask a CRO
While I was browsing through my website analytics, I came across the above question that was entered into a search engine which in turn directed somebody to the website. It got me thinking what a great question it was! So, from … Continue reading
Posted in Compliance, Records management practice
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eTMFs from your Contract Research Organization (CRO)
I was recently asked what happens at the end of a clinical project when the CRO managing the study wants to hand over an electronic trial master file (eTMF). The sponsor may not have an existing eTMF to take the … Continue reading
Posted in e-records, Technology, TMF
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PDF/A Standard Now Uses PDF v1.7
The International Organisation for Standardisation has just released the second part of its standard for long-term digital preservation of documents, ISO 19005-2:2011. The first part of the standard (ISO 19005-1) was issued in 2005 and describes the file format PDF/A … Continue reading
Posted in Document Storage, e-records, Technology
2 Comments
