The need for accurate and comprehensive pharmacovigilance reporting to monitor benefit vs. risk profiles throughout clinical trial phases and post marketing is a legal requirement.
Under EU directives, information regarding adverse reactions must be retained. The usual form of reporting adverse reactions by practitioners and the public is via the MHRA yellow card scheme, telephone call and now increasingly email.
As the extent of clinical data originating and retained in electronic format continues to grow, the systems used to hold and access to this data have a requirement to evolve too. It is already the case that electronic records under regulatory control (FDA 21 CFR part 11) must be available for inspection when required. Failure to find and produce a relevant email for example can result in an offence with as serious consequences as an FDA 'Warning Letter'.
Email: A common misconception
Standards and available resources vary widely from one pharmaceutical organization to another. Organizational email systems are frequently relied upon for storage, retrieval and protection of trial and regulated data. In most cases however, users' expectations far exceed what is possible with commonly deployed email systems. Even allowing for good standards of network access security and data backup, most organizations have an unexpected and significant hole in their pharmacovigilance reporting. Honest answers to some of the questions below help reveal the problem:
- Can emails within your organization be deleted at will?
- If a newly received email is deleted before the nightly backup run, is there any record of it?
- Can data in your email system be modified in any way? If so, how do you plan to show at some future date that the email saved was not the original?
- Does your organization possess more than one email repository? (e.g. for regulatory affairs, safety, clinical and post marketing etc...) Can you reliably access and search all of these?
- What effort and amount of time does it take to search for data across all of your email archives?
- What controls do you have in place for auditing who accessed emails containing regulated and/or sensitive personal data?
Considering the above, are you in a position to confidently testify that:
- Trial data held in email was not omitted, altered or deleted?
- You have delivered up all evidence retained by your organization should an investigation regarding a particular case of adverse reaction call for it?
- You took reasonable steps to collect and safeguard original source trial data held in your electronic messaging systems?
Plugging the gap
At FORENSIC & COMPLIANCE SYSTEMS, our Pharmacovigilance Forensic Messaging Archive System helps address the issues of exhaustive retrieval of emails and other electronic communications by pharmaceutical and life science organizations working within regulatory frameworks.
FORENSIC & COMPLIANCE SYSTEMS's Cryoserver sealed appliances provide a permanent, tamper-evident repository of all emails sent to, from and around an organization, suitable for legal and regulatory compliance and for providing emails in court with high evidential weight. Cryoserver is often likened to a black box flight recorder for electronic communications combined with internet search engine-like performance and simplicity.
Using Cryoserver, your organization can find any email sent or received within seconds. Not only useful in retrieving electronic records when investigating a case of adverse reaction, but also for helping your organization in a wider capacity, such as with dispute resolution or more general records management requirements. Cryoserver is also invaluable in situations where you need to show that you were not sent something, for example in dealing with false claims from the public that a reaction was reported via email.
Cryoserver typically only takes a few days to install and is a completely separate standalone audit system which can operate without interference with the live flow of messages from an organizational email system.
For more information or to purchase the Cryoserver Pharmacovigilance Forensic Messaging archiving system, please contact us.