for Regulatory Correspondence and Commitments
Correspondence and Commitment management made simple
Over 70% of regulatory activity focuses on maintenance of existing products and submissions. A time consuming and business critical part of this is managing interactions with Agencies and Post-Marketing Commitments.
Contacts with regulatory authorities involve metadata being captured, with intelligent inheritance / pre-population from existing / template forms, together with value assistance across multiple fields, with dependencies based on the process of users. Additionally, contacts often have associated content (emails, documents, faxes, multi-media) which needs to be attached, and routed together.
Being able to then plan and manage Post-Marketing Commitments in the context of the agency interactions and also the submission documents, tied together with CARA IDMP and RIM modules, is very valuable.
- Form configuration including tabs, columns, grids (table of data)
- Complete the forms using browser or mobile device
- Values from queries, value lists, dictionaries and Master Data
- Full range of controls including text, dates, integers, picklists, radio buttons, checkboxes
- Set fields to be visible, mandatory and/or editable based on conditions
- Inter-field dependencies
- Full CSS / HTML formatting
- Field validation such as date ranges, text string masks and regex validation
- Import or attach documents directly onto forms
- On saving the form, automatic relationship are built between the form and attachments
- Clone metadata from forms to attachments
- View, edit and otherwise work on attachments from the form on in the repository
- Extract attachments from emails, and extract metadata from documents and emails on import
- Use Documentum BPM workflow or CARA workflows to route the form and attachments
- Full lifecycle (Documentum standard lifecycle)
- Dashboards to report (BAM not required)
- Synchronise lifecycle state and metadata across forms and attachments in the background
- Multiple form handling for workflow, status, annotations and more
- Tie the correspondence to the original submission documents