SharePoint Records Management for Pharma
Montrium’s SharePoint Records Management for Pharma is a cost effective alternative to traditional records management systems. It is based on the core Records Management functionality within SharePoint and fully integrates with SharePoint Workspaces for Pharma. Montrium’s approach to records management is based on a central file plan. This file plan outlines document hierarchy and record classification attributes. This file plan is used to manage document management organizational structures and automated central filing in the product or trial master file. In addition to the document hierarchy, the file plan also contains attribute data which is used by Montrium’s Document Lifecycle process to route documents for review, approval and archiving based on document type.
Document Lifecycle Process Components
Managing document status and versioning as it moves through review and approval can be challenging. Montrium’s Document Lifecycle Process (DLP) can help. Our DLP module is a series of interactive workflows and components which facilitate the authoring, identification, review, approval and archival of documents and records. These workflows have built in flexibility to route documents to the relevant reviewers and approvers based on document status and characteristics defined in the file plan. The document lifecycle process has a built in state model which manages document status. This allows users to know who is currently working on and the current status of any given document. The DLP is typically used for all controlled documents and can be integrated with all SharePoint workspaces.
Integrated Submission Ready PDF generator
Montrium has partnered with Adlib Software to provide an integrated Submission Ready PDF generator within its workspaces and records management system. This generator is capable of automatically producing PDFs and applying relevant regulatory publishing options and characteristics based on document type. These options are defined in the central file plan to individual document types or groups of documents. The PDF generator is also capable to converting InfoPath forms directly into PDF format based on predefined PDF templates. These PDF renditions can then be digitally signed and stored as records.
Integrated Digital Signatures
Montrium has partnered with Arx (Algorithmic Research), the life sciences industry leader in digital signatures, to integrate CoSign digital signature technology into its records management system. Documents and records can be digitally signed directly within the document, from a SharePoint library or within a SharePoint workflow tasks. These signatures can be used with mainstream document authoring software such as Adobe Acrobat, MS Word and MS Excel as well as MS InfoPath forms.
Records Centre / Product & Trial Master File
SharePoint has a built in records management feature which can be configured to organize final records into meaningful document libraries. It is possible to apply retention and information management policies to records based on content type and in line with SOPs and regulatory requirements. Strict security is applied to the records management SharePoint site to ensure that records cannot be modified or deleted.
Montrium has built a custom records center site structure which allows the automatic classification of product master file records based on their classification in the file plan. Records are automatically routed to the relevant sections and sub-sections from the various different document management workspaces based on status. This approach allows for documents to be developed, reviewed and approved within separate departmental workspaces and then be archived in one central file structure in the form of a Product or Trial Master File (eTMF).
Montrium SharePoint Enhancements for Records Management
Montrium has developed a series of SharePoint enhancements which improve on the baseline SharePoint functionality within the context of regulated document management and ensure compliance with 21 CFR Part 11. These enhancements integrate with our SharePoint workspaces and have been fully tested and are accompanied with full technical and validation documentation. These enhancements include:
- Automatic document identifier generation based on document type and other relevant metadata
- Automatic document classification based on the file plan
- Automatic submission ready PDF generation and metadata transfer from source documents to PDF renditions
- Automatic document archiving to the product / trial master file in the records center
- Filtered cascading lookup columns for metadata
- Metadata default value inheritance for bulk document uploads
- Audit trail reporting
