In order to focus on their core competencies and reduce costs, medical device and pharmaceutical companies outsource functions to contract manufacturers, laboratories, and clinical research organizations. These outsource providers can produce documents and emails that are necessary to capture into a central repository in order to centralize the documents and data to build a regulatory submission.
Import and Migrate Documents
Documents can be delivered in a number of different ways and formats. Portford’s DocuNECT can:
- Capture emails that contain important information and decisions that need to be part of the formal record
- Bulk import documents received as part of a document transfer via FTP, secure FTP and/or drives into your document management system (DocuNECT Lifecycle, OpenText Documentum or Microsoft SharePoint)
- Setup a secure document delivery portal that allows outsourced providers to upload documents
- Migrate documents from a legacy document management system
Quality Assurance and Verification
During the migration process meta-data can be associated with the documents either manually or by applying business rules. The documents and meta-data can be reviewed and approved as part of a verification process before they are distributed to the document management system.
Complete Chain of Custody
As documents are migrated into the target document management system an audit trail is produced and stored so a complete “chain of custody” can be established of when the documents were received, to when they were migrated.
System Validation Reporting
A complete report can be produced that contains the documents migrated, the meta-data and associated audit-trail for system validation reporting.