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VALIRA LLC
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  • Information Technology
  • Quality Compliance
  • Regulatory Operations/Publishing
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Quality Compliance

 In a rapidly changing Quality and Compliance regulation landscape businesses need to maintain compliance and follow guidance’s with innovation and agility. Staying healthy ahead of that change and making long-term success in your business needs ongoing Quality and Compliance transformation.
VALIRA Validation Consulting Services provides highly experienced professionals and delivers integrated, end-to-end Quality and Compliance solutions and services that satisfy all types of quality & validation requirement needs across the globe. Our Quality, Compliance and Validation professionals have deep experience applying technologies with applicable regulations to help you achieve business goals and objectives.

Validation Consulting Services: 
  • Computer System Validation
  • Equipment Validation
  • Process Validation 
  • Cleaning Validation
  • Method Validation
  • Supplier Quality
  • Design History Remediation
  • Vendor Audits
  • Third party vendor audit support for FDA 483, Warning Letter & Consent Decree activities
  • Retrospective Remediation Validation Services
  • Enterprise Resource Planing System Validations (SAP, JD Edwards, Agile, LIMS, Enovia, Argus Safety, CTMS, HPQC, PLC Systems and etc.,)
Useful Links:
  1. GAMP Good Practice Guides - ISPE
  2. US Food and Drug Administration
  3. Quality System Regulations
  4. ISO - International Organization for Standardization
  5. Sarbanes-Oxley Law 
  6. ​Health Insurance Portability and Accountability
  7. ​21 CFR Part 11
  8. 21 CFR 210

LOOKING FOR A FDA 483, WARNING LETTER OR CONSENT DECREE SUPPORT?
CONTACT US IMMEDIATELY! WE CAN HELP.

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