Motivated team through good company/HR practices including regular training,
Professionally managed company with a top team having good experience
Validation & Compliance
We provide complete validation suite for automated manufacturing
practices used in pharmaceutical industries. Having
exceptional Exposure to various processes and undertaken
several automation, Software &
validation projects of the automated manufacturing
systems makes us proficient to
take care of validation
requirements and US FDA21CFR Part 11 related issues.
We use an efficient systematic, risk based, quality system approach to developing protocols. We also employ a very pragmatic approach to protocol execution, which allows us
to fulfill all regulatory documentation requirements
efficiently and with minimum of delay and with a minimum of interference with our
customer's operations. We have distinctive
expertise in validation documentation and
Computer System Validation
Laboratory Information Management System (LIMS) validation.
Custom Database and spreadsheet development and validation.
HPLC, GC, SAS software,
Chem Station, WinNonlin, Volunteer Database
Software, LCMS and other Chromatography equipment
software validation, including configuration and validation of
network data systems.
Preparation of validation master plans.
Development of requirement specifications, documentation, traceability matrices and other GAMP documentation.
Equipment Control System Validation
Process Control System Configuration