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Tweets from Rammell Consulting
- http://t.co/ZVaQC55y They've not heard of compliance with retention policies then? Or costs of e-discovery if you keep everything? 1 week ago
- Ensure Your Informed Consent Forms Comply With New Requirements http://t.co/i9aEJH2a 1 week ago
- Received email today from Dept for Bus. Innovation & Skills. Sent to 726 people. All email addresses visible! Worrying... 2 weeks ago
- GMP Directive (2003/94/EC) to cover active substances? http://t.co/0JOmtxib 4 weeks ago
- Is it OK to "manipulate" PDFs to improve records management? http://t.co/Smbl4YQe 1 month ago
Author Archives: rammellel
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
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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
Posted in Compliance, GMP, Regulations
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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
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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 annex 16, GLP, gmp guidelines, good manufacturing practice, QP
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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
Posted in Regulations, TMF
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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
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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
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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
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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
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