SPI - Systems Pros

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Systems Pros

Medical

Systems Pros Medical is a premier staffing provider for the pharmaceutical, bio-technology and medical device industries. We specialize in Quality Assurance, Quality Engineering and Validation of manufacturing, process, and software systems. Our staffing professionals are veterans in their field, ensuring all our clients needs receive the expertise they require.

Validation

  • Equipment Validation
  • Facilities Validation
  • Cleaning Validation
  • Process Validation
  • Analytical Method Validation
  • Computer System Validation
  • Design Qualification- (DQ)
  • Installation Qualification- (IQ)
  • Operational Qualification- (OQ)
  • Performance Qualification- (PQ)
  • Standard Operation Procedures- (SOPs)
  • Validation Master Plans- (VMPs)

Quality Assurance

  • Remediation
  • Gap Assessment
  • Risk Management
  • CAPA
  • Complaint
  • Auditing
  • Compliance
  • Quality Systems
  • Software Quality Assurance

Regulatory Affairs

  • Strategy/ Submissions
  • Pre & Post Market Approvals (PMAs)
  • 510(k)
  • Investigational Device Exemptions (IDEs)
  • Investigational New Drug Applications (IND)
  • New Drug Applications (NDAs)
  • Biological License Applications (BLAs)
  • Chemistry, Manufacturing & Controls submissions (CMC)
  • Adverse Event Reports (AERs)
  • Registrations/Filings