• 1230 Colombia St, San Diego CA 92101
  • Free Consult(619) 770-9000

Validation Engineering

BCVS professionals possess a group of highly experienced professionals in validating medical device, pharmaceutical and biotechnology manufacturing processes. By partnering up with the Product Development, Supply Chain, R&D, Operations, Quality Assurance, Regulatory Affairs personnel, BCVS will ensure that all regulatory requirements and specifications are met.

We understand the importance of complying with regulatory guidelines and BCVS has a proven track record of excellence by developing Validation master plans, validation protocols, and validation reports. We strive to personalize our services to cater to your company standards by working closely with your validation, engineering, quality assurance and regulatory affairs department. Computer Systems Validation

  • 21 CFR Part 11
  • Data Integrity
  • GAMP5
  • Risk Assessments and Regulatory Scope Determination
  • Validation Plan
  • URS /FS /CS/DS
  • IQ/OQ/PQ Protocols and Reports
  • Disaster Recovery
  • Business Continuity

Process Validation (21 CFR Part 820, 21 CFR Part 210, 211)

Manufacturing Equipment / Lab Equipment Validation

  • Factory Acceptance Testing FAT
  • Site Acceptance Testing SAT
  • DQ/IQ/OQ/PQ Protocols and Reports
  • Development and modification of Standard Operating Procedures (SOPs) and Forms for equipment and systems
  • Training materials- Job Aids / Work instructions
  • Structured writing method for SOPs & Templates developments

Cleaning Validation

  • Cleaning Techniques
  • MAC and MACO Values
  • Bioburden
  • Endo-Toxin
  • TOC
  • Riboflavin Testing
  • 24-hour Hold time study
  • 24 Hour Recovery Study
  • Clean-in-Place (CIP) cycle Development and Executions
  • Sterilization-in-Place (SIP) cycle Development and Executions

How can we help?

Schedule a free, no obligation consultation with one of our experts. With over 700+ employees dedicated to this industry across different regions in the world, we offer full time, part-time resources as well as managed services offerings to address your needs.