When eCTD was introduced more than a decade ago, the implementation of a new Submission Management Solution (SMS) was primarily a technical challenge and an adventure. Tool vendors were focused on creating submissions using documents from Document Management Solution(s) (DMS) and then publishing eCTD sequences compliant with agency specifications. From a process perspective, this was a new clean step without technical connections to the legacy – either paper or electronic submission of other formats. Project work on legacy submission migration was not needed.
With SMS now in production for several years a legacy exists as a larger stock of submissions in eCTD format. Due to the kind of application processing in nearly all ICH countries, all historic submissions must remain managed and technically connected for the life cycle of a pharmaceutical product.
Organizational and technical developments occurring over many years in pharmaceutical companies sometimes necessitate replacing existing DMS and/or SMS. This creates a new challenge in managing a large scale migration process while continuing existing regulatory activities.
When adopting a new SMS, a larger stock of submitted eCTD sequences must be processed (validated and imported) in a controlled environment. When adopting a new DMS, a larger stock of documents must be migrated and relinked to existing SMS.
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