Skilled professionals.

Motivated team through good company/HR practices including regular training,

Professionally managed company with a top team having good experience

 

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 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.
  • Development of SOPs for operation of laboratory equipment and manufacturing equipment.

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  Validation & Compliance Services

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