If you look through my blog posts and LinkedIn updates over recent years, you’ll be forgiven for thinking that all I do is support pharmaceutical companies with their trial master files (TMFs). It is true that this has taken up a significant proportion of my consulting time in the last 5-7 years, largely because of the heightened focus on these records by regulatory authorities. And it is always enjoyable to work with my TMF colleagues…. we joke that “TMF” actually means “Too Much Fun”!
However, I’d like to take this opportunity to remind you that we do much more than this! Let’s run through the scope.
In terms of the industry sectors that I support, my main experience and expertise is in health sciences…. so that is the pharmaceutical and biotechnology industry and other organisations that work on health, medical devices and medicines development. However, I also have experience in other sectors, such as financial services, education and engineering services. Many of the records management principles that are applicable in health sciences are transferable to other sectors.
What aspects of records management do I support? I guess the right question to ask is what aspects of records management do I NOT support! I actually cover most, and this would include:
- Policy development, for example: records management policy to comply with GDPR and other requirements; legal hold policy to prevent the inappropriate destruction of records during litigation or other disputes; IT acceptable use policy; employee exit policy to ensure the orderly management of records prior to employees leaving the company. Do you have all of these in place?
- Process development, for example: processes to support the identification, classification and correct disposition of records; processes to support creation and management of an archive (on site, off site or digital); optimisation of record keeping processes in specific business functions; alignment of record keeping processes with applicable regulatory requirements to ensure compliance and efficiency.
- Record classification, including the development of taxonomies that support effective management of records in the business, in records centres, in archives and that support defensible destruction. Associated with this is the review and/or development of records retention schedules…. having in place an approved document that describes how long specific types of records are to be retained for (for most companies, this is a requirement of GDPR).
- Training, including development and (if needed) delivery of training to support your records management policies and procedures, record clean-up days, GDPR requirements.
- Strategy development, providing advice and support in areas such as deployment of electronic signature technology, organisational models for records management support, outsourcing of record keeping activities, and risk management.
And the list goes on! In short, if your organisation has records management issues that you are struggling to manage because of a lack of experience, expertise or resource, please reach out to me. I’m here to help!
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