Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

Document Storage Industry Suffers Another Fire

Despite making significant investments in fire protection facilities, it seems our records can still be at risk. Metrofile, a large commercial document storage vendor based in South Africa, suffered from a devastating fire last week at their Westmead, Pinetown facility. The … Continue reading

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Retention Scheduling? Don’t Forget Data Protection Laws!

Research recently conducted by PwC on behalf of Iron Mountain suggests that more than a third (35%) of small European companies are risking prosecution by “hoarding” data beyond the scope and period required by data protection legislation. When these companies were … Continue reading

Posted in Compliance, Data protection, Records management practice | Leave a comment

Is an eTMF Standard Needed?

This is a question that many of us in the clinical document management space are currently asking ourselves following the announcement by CareLex of their intention to develop and launch an industry eTMF standard under the auspices of OASIS. There already … Continue reading

Posted in e-records, Records management practice, Standards, Technology, TMF | 1 Comment

Proposed EU Clinical Trial Regulation – Update

Well, my optimism from our meeting with one of the UK MEPs a short while ago was misplaced! It appeared a possibility that the intention was to only retain the clinical study report indefinitely and not the whole of the … Continue reading

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When Is a Photocopy Not a Photocopy?

It appears that the answer may be when you use a Xerox scanner to produce the copy! According to a story reported today, the “normal” scan settings on at least two models of Xerox scanner actually change the characters that … Continue reading

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Where Are We With ‘Digital By Default’?

The UK eGovernment Interoperability Framework (eGIF) was established over 10 years ago to include a range of different initiatives to make Government more efficient by introducing standardisation. Part of this strategy included the goal of moving towards the digitisation of … Continue reading

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When is a CSR a TMF?

It appears that the anxiety within the industry regarding the proposed Trial Master File retention requirements in the draft EU Clinical Trial Regulation may be unfounded. Earlier today I had the pleasure of meeting Mrs. Marina Yannakoudakis MEP at her … Continue reading

Posted in Regulations, TMF | Leave a comment