Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

Do You Destroy Records Securely?

When it comes to destroying records at the end of their retention period, I’m guessing that most records managers and archivists will have a well-established program to ensure such records are destroyed securely. There are industry standards for secure destruction, … Continue reading

Posted in Document Storage, Records management practice, Technology | 1 Comment

Use of Digital Signatures

I’ve just come across a White Paper from AIIM on the use of digital signature technology. As this makes for interesting reading, I thought I’d just share some highlights and provide a link to the full report: In 63% of … Continue reading

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Is Facebook a Validated System?

Well, of course the answer to the question posed in the title is a clear “No”…. at least as far as the pharmaceutical and biopharmaceutical industry understands and interprets validation. So why the question? My eye was drawn to an … Continue reading

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Ensure Your Informed Consent Forms Comply With New Requirements

For those sponsors conducting clinical trials that need to comply with FDA regulations, remember that from 7th March 2012 your informed consent documentation must comply with the new 21 CFR § 50.25(c) requirement. This requires the informed consent form to … Continue reading

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GMP Directive (2003/94/EC) to cover active substances?

The European Commission are proposing to extend the scope of Directive 2003/94/EC to cover active substances, including the manufacture of active substances. The intent is to bring cohesion of requirements for active substances and medicinal products. However, since all of … Continue reading

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Is it OK to “manipulate” PDFs to improve records management?

This is a question that I hear posed fairly frequently, I guess as a result of organisations managing electronic records rather than – or in addition to – traditional paper records. A typical scenario is an electronic document received into the … Continue reading

Posted in Compliance, e-records, Litigation, Records management practice, Regulations | 1 Comment

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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