Document Composition software vendor with >350 customers in central Europe (SAP)
Our client is the well established business unit of a large software company. This business unit has developed a robust, industrial strength document composition engine, which differs from typical document output vendors’ solutions, due to its focus entirely on ERP systems users and, in particular, SAP. 70% of their customers deploy the solution, tightly integrated with SAP, which is the catalyst for their extensive SAP certification (BC-RDI, BC-XSF, BC-XFP). In addition, they provide full Unicode support, which enables customers to deploy the software worldwide, in any language, from one central location.
Their solution is used for document production, multi channel delivery, postal optimization (bundling), centralized printing and handling across all known printers, without losing format, distributed printing plus automatic archiving back into SAP-ArchiveLink.
More information can be obtained from your Regional Manager at Document Boss or via our European Manager, Geert Kruiter at firstname.lastname@example.org.
Solution Vendor, specializing in the Pharmaceutical/Life Sciences sector
Our client is a well established, software development company, which specializes in providing advanced solutions for the Pharmaceutical industry and Life Sciences sector. Their flagship product is a fully configurable web solution, conforming to all regulatory and compliance standards for the global management of electronic records, documents and processes in a collaborative environment. Their platform meets or exceeds compliance requirements, including FDA 21 CFR #11, cGMP, ISO 9001 and many other international standards. The solution can be deployed within any pharmaceutical company to comply with the requirements for:
• Research & Development
o Planning, Formulation development, Pilot development, Manufacturing procedures, Process validation, etc.
• Quality Assurance and Quality Control
o Quality Policies and guidelines, SOP and CAPA Management, Validation, Audits, etc.
• Regulatory Affairs
o Support of all dossier publishing formats, including NTA 98, CTD, eCTD or other country specific submission formats (CIS region, ASEAN countries, etc.)
o CTD (PDF) and eCTD Publishing from the same structure
o All of the technical controls for 21 CFR Part 11 compliance are built in
o Many more capabilities to meet all regulatory requirements
o Electronic submission of Individual Case Safety Reports (ICSR/eICSR)
o Automatic update with MedDRA
o Knowledge Base etc.
• XEVPRM (The new reporting standard Extended EudraVigilance Product Report Message)
o Structuring and collecting XEVPRM data
o Creation of XEVPRM
o Creation of submission etc.
The company signed up many new pharmaceutical clients last year, one of whom has already decided to roll out the solution enterprise-wide and across all their locations worldwide.
More information can be obtained from your Regional Manager at Document Boss or via our European Manager Geert Kruiter at email@example.com.