Reliable documentation – in all areas
Business processes in the pharma industry generate a large number of complex documents, complex because of their interrelation with other documents:
- The composition of pharmaceuticals found in the patient information also occurs on the artworks for packaging. (Labeling and artworks documents)
- A feature described in a functional specifications document links to an item in a user requirements specifications document and must be referenced in the relevant test documents. (GAMP documents)
- Clinical study reports contain data that must be kept up to date with the latest information from the lab information systems until the reports are released. (eCTD documents)
Collaboratively created, these documents are often edited in relation to one another. The usual method of editing documents individually with Microsoft Word and then checking them into a document management system (DMS) is inadequate for this working process.
SCHEMA and its XML editing and content management system offer tried and tested methods and tools for collaborative document creation and editing. The requirements of established standards such as GAMP, QRD, or SPL/PLR can be implemented with SCHEMA ST4.
- SCHEMA ST4 supports collaborative work on text and content. Role-based permissions ensure that information modules are not edited simultaneously and unreleased data remains unavailable for production.
- The integrated publishing framework allows for parallel publishing according to regulatory Word documents as well as print-ready artworks.
- System-based correction and release workflows, as well as automatic data updating, ensure comprehensive process safety. Creation processes are documented continuously. An audit trail for each information unit or document contributes to the transparency of the process. Changes to product descriptions may be viewed at any time.
- Integrating SCHEMA ST4 into existing IT landscapes makes it possible to create a central data repository containing all product descriptions, information and master copies. Interfaces with Documentum, Oracle Agile or SAP, among others, have been implemented for numerous customer projects.
- Processes for creating and managing information in the pharma and life sciences industries are highly complex and cost-intensive. SCHEMA ST4 offers efficient workflow functionality.
- Processing times are reduced and errors during updates minimized.
As SCHEMA is already used in the pharma industry, we understand your need for
- On-site auditing
- Project delivery according to GAMP
- CFR 21 Part 11 compliance.