Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

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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

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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 | 2 Comments

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 | Leave a comment

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 | 1 Comment