Synt_BR_ Document Management-One Pager

 

Centralized Global Partner to Support Scalable Model for Future Generation e-DMS Dealing with multiple Document Management Systems (DMS) across multiple teams around the globe is a challenge for the Pharmaceutical industry. In order to realize tangible benefits from their current DMS, organizations need to address issues such as complicated infrastructure, scalability and regulatory compliance. An integrated, scalable and centralized DMS is the need of the hour. Life science companies across the globe need to align their DMS to multiple teams and business processes, while addressing quality and regional requirements. Mergers and acquisitions further complicate the process and infrastructure with new systems, formats and procedures. Organizations not only need technology partners who can build such a DMS, but also implement the DMS to capitalize on their investment.

SOLUTION HIGHLIGHTS

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• Syntel’s Solution

Syntel has developed an end-to-end clinical DMS solution with a team of experts with hands-on experience in DMS while working with clients in the life sciences space. Our solution addresses the needs and challenges associated with DMS and helps implement harmonized business processes within the organization. With our integrated IT-KPO services approach, the centralized DMS support team publishes and manages documents and supports end-to-end documents management services. Integrated audit and inspection-ready platform ensures 100% compliance to regulatory requirements. The DMS services also address cloud-based DMS requirements including flexible deployment, workflow management and helpdesk support among others and help reap cost benefits. This solution provides services across: • Business process • eDMS application support/management • System infrastructure infrastructure including cloud

Business process management • Scanning/Indexing • Documents QC • Naming Convention • Archival/Retrieval • Security Management • Documents Migration

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eDMS application support

Infrastructure management

• Electronic Trial Master File (eTMF)/Electronic Common Technical Document (eCTD) software management

• Cloud Services • Validations/Compli Validations/Compliance ance • Application Support • Third-party Management

• eTMF Tool Services • Scanning/Optical Character Recognition Tools • Helpdesk Management • Request Management

End-to-End DMS Solution’s Services

Business Benefits • eRegulated content content always in an inspec inspection tion and audit-ready state • 35% faster turnaround turnaround of document proc processing, essing, owing to impro improved ved quality gates and proce process ss accelerators • Overall DMS process process standardization and harmonization • 34% savings in managing managing DMS activities activities over three three years • Consistent 99.96% quality quality score over five years and counting • Supported EMEA and FDA inspections with no major observations

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3500+ person-years’ experience in DMS Over 550 dedicated employees for DMS, with a commitment of 50% ready team for new clients Audit and inspection-ready platform Processed over 20 million documents for top three life sciences organizations End-to-end DMS support, including: • Paper trial master file (TMF) and eTMF support activities • Scanning and indexing • Quality control and compliance support activities Application support, migrations, infrastructure support, etc. Dedicated CoE for Regulatory Affairs and Compliance, for solutioning and ensuring compliance to industry regulations Leveraging strong partnership with industry leaders for major eDMS applications for the life sciences domain Dedicated Health Care and Life Science University for continuous training programs A GxP complaint environment for clients to support any project audits, project specific documentations and training

For more information, visit Syntel online at www.syntelinc.com or call us at US/+1 (248) 619-3503, UK/+44 (0) 207-636-3587