Project

Snapshot
Syntel Takes Over
Records Management
for Global Pharma
A global pharmaceutical
company needed help
reconciling records from
multiple sites. Record
collection was time
consuming and expensive
and the lack of standards
made it impossible to
scale operations and meet
regulatory requirements.
They turned to Syntel for a
solution.
Solution
Syntel established an on-
site operation to work with
the client to standardize
clinical and regulatory
records and scan them
into a secure networked
file system an Electronic
Document Control Center.
An offshore team of
quality control specialists
conducts quality checks
on the record, ensuring
the established standard
format and naming
conventions are applied.
They fulfill all requests
for records from internal
clinical and regulatory
groups.
Continued on Page 2
Successful organizations need to reduce risks, work more efficiently
and constantly innovate to stay competitive. Whether you need
to manage an inventory of records, comply with global records
management trends or increase work transparency, youre going to
need professional help. Syntels shared service model of operations
is the ideal partner to manage your enterprise-level records.
Syntels Record Management solution helps life science organizations gain
the capability they need to manage their records more proficiently. The
solution provides powerful features that help organizations retrieve and
track their records, quickly and easily.
Focused Approach to Pharmaceuticals Industry
Records Management is one of the most important functions of todays
pharmaceutical organizations. However, many organizations still maintain records in
physical format, relying heavily on overworked staff to manage them.
Syntels Records Management solution for the pharmaceutical value chain
covers all areas ranging from drug discovery and preclinical, drug development,
manufacturing and operations as well as sales and marketing process.
Improve Records Management
Compliance and Accelerate
Records Retrieval
Drug Discovery
and Pre-clinical
records
Clinical
Development
Records
Manufacturing
and
Oerations Record
Sales and
Marketing
Records
Pharmaceutical Ecosystem
I
N
D
N
D
A
P
M
S
Enterprise F&A, HR Records
IND - Investigational New Drug Application
NDA - New Drug Application
PMS - Post Marketing Surveillance
Results
The customer is pleased
with the quality scalable
model Syntel implemented
and is enjoying the
following benefits:
TCO reduced 16% in
the frst year
Increased operational
efciency by 15% in frst
year
Compliance to industry
standards
Easier access to records
Faster reconciliation of
records from global sites
Scalable resource model
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
Improve Records Management Compliance and Accelerate Records Retrieval
2011, SYNTEL INC. 072011
The Syntel Approach: A Three-Tier Records Management
Strategy
Syntel understands that most life sciences organizations have records in many formats
paper, EDC, scanned, etc.
Our three-tier portfolio offering was designed to accommodate this fact as well as to provide
end-to-end coverage.
To transition from your current paper based formats to electronic versions, Syntels solution
fosters an integrated, collaborative approach that can help you track and retrieve your
records faster.
PHYSICAL RECORDS SCANNED RECORDS ELECTRONIC RECORDS
Catalogue Management
Source Document Reconciliations
Metadata Management
Query Management
Stakeholder Communications
Quality Management
Final Repository Control
Physical Copy Reconciliations
Scanning Vendor Management
E-Cataloguing
Metadata Management
Query Management
Quality Management
Final Repository Control
E-Categorization
E-Cataloguing
Metadata Management
Query Management
Stakeholder Communications
Quality Management
Final Repository Control
Offshore Center of Excellence
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Features
Skilled, experienced resources in handling clinical / regulatory documents
Standardization of operation by creation of SOPs / SOIs through project experience
End-to-end project management inclusive of vendor scanning
Labor arbitrage helps realize savings of 20 percent
In-house tools for attribute mapping result in 30 percent increase in efficiency
The Syntel Solution: Best-in-Class Business Practices
Syntels dedicated offshore Records Management Center of Excellence (CoE) was built
specifically to meet the need for highly secure and controlled records transactions and
access. The CoE is a shared-service center that delivers quality outcomes to records
managers across regions, managing complex access and diverse category of records.
Advantages of the CoE include:
Operates in 24x7 mode
Caters to varied records needs of authorized stakeholders
Staffed with authorized and trained Records Managers who are physicians,
pharmacists and GXP-certified professionals
MHRA audited secure facility
LEAN and Six Sigma compliant processes for improving production timelines
Flexible engagement models offer solutions under many models including on
consultation basis