Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

What solution for my eTMF?

We often get asked what technology solutions are available for the management of electronic trial master file content. There are countless companies that provide bespoke IT development services to build your own system, often based around Sharepoint or Documentum. However, … Continue reading

Posted in e-records, TMF | 1 Comment

Search FDA Warning Letters

Did you know that the FDA have recently (26th May 2011) provided an advanced search capability on their Warning Letters web pages? The advanced search page now gives you the ability to search for company name (including wildcard), date range … Continue reading

Posted in Compliance | Leave a comment

Guidelines for GP Electronic Patient Records

The Department of Health have recently (21 March 2011) revised their good practice guidelines for GP electronic patient records. I’ve just been browsing through the document and whilst much of the content is not directly applicable to me, I was … Continue reading

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Financial Disclosure to FDA – New Draft Guidance Available

Yesterday, 24 May 2011, the Food & Drug Administration (FDA) released for public review and comment a draft revision of the guidance for financial disclosure by clinical investigators. This will replace the last guidance issued back in 2001. The revised … Continue reading

Posted in Regulations, TMF | Leave a comment

NIST Releases New Draft Cloud Computing Synopsis

The National Institute of Standards and Technology (NIST) has released a very interesting (but long!) document (click HERE to download) that explains cloud computing technology in plain terminology. At 84 pages and 1.9Mb, it is not a brief document but … Continue reading

Posted in e-records, Technology | Leave a comment

Retention schedules – Finding your way through the maze

The development and use of records retention schedules is fundamental to good records management practice. However, it is a topic that is often misunderstood and one that frequently poses a challenge to records managers and archivists. The records manager has … Continue reading

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Use of the DIA TMF Reference Model by CROs

Here’s a quick plug for a great article about the use of the DIA TMF Reference Model by CROs. The Reference Model is a standardized model for the structure and content of the essential documents that comprise the trial master … Continue reading

Posted in e-records, Records management practice, TMF | Leave a comment