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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