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Post-Market Compliance

After a product enters the market, there are still many areas to address to remain compliant. These areas include packaging, labeling, and of course, the manufacturing! And this could include a myriad of activities that range from warehousing and distribution to sterile vs. non-sterile environments. Our company has the knowhow and expertise to delve into the details of each of these areas and help companies STAY compliant throughout the life cycle of the drug or device.

An example for post market activities for Analytical Labs includes Stability Programs. Stability methods, the chamber qualification, and personnel all make up a good stability program. Not only does USDM audit stability rooms routinely for proper mapping of RH and temperature, but also the qualification data, stability-indicating methods, training and overall programs as well as provide guidance.

USDM is also highly experienced in Part 11 compliance in all types of systems including MES, HMI’s, PLCs, SCADAs, and other types of hardware, to SAP, CRMs, IVRS and desktop off-the-shelf systems.

Other specifics include:

  • Post Market Surveillance Programs, Pharmacovigilence/Data Management/DrugSafety/Adverse Events/Significant Adverse Event Programs/Suppliers
    • IVRS Data Integrity Audit
    • Post-Marketing AE Reporting
    • REMS/RiskMap Assessment
    • Specialty Pharmacy Inspection for REMS AE Reporting Compliance
    • Adverse Drug Experience Gateway Evaluation (tool evaluation, e.g. Oracle AER)
    • High Risk Drug Product Risk Evaluation & Mitigation Strategy (REMS) Programs including Elements to Assure Safe Usage (ETASU)
  • Analytical Laboratories
    • Microbiology Laboratories/Programs
      • Microbiology Laboratory Systems: analytical techniques, methods qualification, etc.
      • Stability Program Design
    • Particle Size / Surface Morphology Analytics
      • Particle Reduction Size Laboratory Audit
      • Particle Morphology Data Audit
  • Stability Programs
    • Stability Method Validation
    • Stability Room Qualification
    • Stability Test Assessment
    • Stability Test Result Evaluation
  • Computer Systems
    • Computer Systems Validation Governance/Methodology
    • Computerized Systems Used in conjunction with Production or Quality Systems used to satisfy predicate rule commitments
    • 21 CFR Part 11 & Annex 11 Compliance
    • Software Suppliers/Developers & Software Quality Assurance/Engineering Programs/Practices
    • Pre-UAT, Pre-Go Live Readiness Audits & Post Go-Live Audits
    • Software-As-A-Service (SAAS) Hosting Vendor Audits including SAS 70 Type II Audits
    • IT Disaster Recovery Program/Site Audits including Recovery Time Objective (RTO) & Recovery Point Objective (RPO)
    • IT Infrastructure/Governance Audits