Computer System Validation Services

Valoit  provides a suite of validation services for GMP, GCP and GLP applications used  in pharmaceutical,  biopharmaceutical and medical device industries.  Valoit  has built a reputation in  the field of  computer  validation. Our expertise in automation and information technology, equipment, processes and  regulations makes us uniquely  suited for developing  and validating  integrated manufacturing systems and hence provide you with a TOTAL SOLUTION.

We excel in both technological and regulatory fronts, which puts us in an advantageous position to meet our pharmaceutical clients’ computer validation needs. 

Our Computer Validation Group can tailor a solution to meet your needs, whether you have a simple PLC system, complex ERP, EDMS (Electronic Document Management Systems) MES or DCS systems. We are leveraging our know-how in technology and regulations to provide 21 CFR Part 11 or Electronic Batch Records and Electronic Signatures (EBR and ES) solutions for our clients.

We use a "systems" approach to validation, integrating validation needs in the short and long term, hence providing a cost effective and robust solution. This integrated approach to validation, which is based on our collective expertise in technology, processes and regulations, adds value to our clients.

Prospective & Retrospective Software Validation

Valoit has the technical expertise and the regulatory insight required to provide cost-effective and time-efficient validation solutions for today’s computer systems:

  • Quality Documentation Systems
  • Laboratory Information Management Systems (LIMS)
  • Programmable Logic Controller (PLC)
  • Chromatography Data Systems
  • Distributed Control Systems (DCS)
  • Facility Monitoring Systems (FMS)

cGMP Compliant Documentation

Our validation specialists understand the level of documentation and testing required for cGMP compliance, and are proficient in protocol and procedure development, and validation plan execution.

  • Standard Operating Procedures
  • Installation Qualifications
  • Operational Qualifications
  • Performance Qualifications

Validation Master Plan & Audits

The Valoit, Inc. validation team has extensive experience auditing existing systems and formulating, prioritizing, scheduling and implementing Validation Master Plans at the system, department and corporate levels.

  • Quality
  • Regulatory
  • Laboratory
  • Research
  • Production

Support for System Designers

Our validation services extend beyond users of purchased systems. We provide validation assistance to system designers and manufacturers to ensure the production of a validatable and compliant product.

  • Life-cycle Approach
  • Validation Training
  • Documentation Development
  • Certification Procedures
  • Qualification
  • Audits

Prior to Production Startup Equipment Validation Facilities Validation Computer System Validation

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