Expertise |
The Patni Life Science Practice is the global organization that can support your
processes and systems from conception and design through validation and support
across the entire drug or medical device life cycle. Capabilities include ERP,
safety and pharmacovigilance, SAP, LIMS, and lab informatics, clinical and
regulatory, MES, CAPA, EDMS and regulatory compliance.
Strategy and Planning Services: |
 |
Development and implementation of corporate policy, divisional standards, procedures, and training programs related to compliance with GxPs, QSR, pharmacovigilance, PDMA, and 21 CFR Part 11 |
|
Assessment and business process improvement related to drug safety reporting and pharmacovigilance; and compliance with recent FDA risk management guidances including “Good Pharmacovigilance Practices” |
|
Assessment and business process improvement of the laboratory environment to reduce total cost of ownership, identify return on investments, enhance service levels, and reduce risk |
|
Enterprise-wide assessment of processes and procedures related to computer system validation aimed at reducing annual spending and increasing compliance |
|
Program Management Office set-up and operation |
|
Development and implementation of methodology that supports multi-site
integration of CAPA, deviation, change control, and other quality systems |
|
| |
| Validation and Compliance Services: |
|
Computer system validation planning and implementation - for clinical, submissions, laboratories (R&D and manufacturing), drug safety operation, manufacturing, and sales / marketing systems |
|
Process control system validation / qualification - planning and implementation, including shop floor systems and equipment, building automation / building management systems, SCADA, PLC, DCS, and MES |
|
Vendor and System Audits |
|
Training |
|
| |
| System Implementation Services: |
|
System upgrades and replacements that support the entire drug development life cycle: discovery through post-marketing |
|
Support full development life cycle including project management; business process and requirements analysis; system evaluation and selection; system design, implementation and testing; validation; system retirement; maintenance and support; and training |
|
| |
| Patni Life Science Practice: |
|
Providing services to 18 out of the top 20 life science companies |
|
Business focus: Implementation of solutions that increase efficiency across the drug development life cycle while ensuring regulatory compliance and product safety |
|
Global delivery capabilities |
|
| |
 |
| |
