Software Validation & Compliance Services

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 & GAMP 5 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 validation implementation.

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.

Automated Manufacturing Equipment Control System Validation

  • Process Control System Configuration and validation.
  • Automated manufacturing software (SCADA) validation.

21 CFR Part 11 Compliance

  • Compliance assessment of laboratory, manufacturing, and support systems, with consideration given to FDA's Guidance document.
  • Configuration, remediation, and validation of deficient systems.

Procedure Development

  • Preparation of procedures for the operation and administration of computerized systems.
  • Development of change control policies and procedures.