Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

Posted in Compliance, Regulations | Leave a comment

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

Posted in Compliance, GMP, Regulations | Leave a comment

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

Posted in Regulations | Tagged , , , , | Leave a comment

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 | Leave a comment

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