Quality Systems &

Regulatory Compliance

Define and establish a better road to compliance in manufacturing and laboratory operations including all Quality Systems (Process and Laboratory Investigation, CAPA, Change Control, Training, Document Management and Control)

Help our clients to accomplish the right balance of regulatory compliance and profitable business operations. We assure compliance by helping clients to establish a complete strategy in a regulated industry in areas such as:

  • Basic concepts in Cleaning Validation
  • Laboratory Analysts Certification Program
  • Trainings on Documentation & Quality Systems
  • GxP’s applied to functional areas
  • New Hires Certification

Facilities &

Utilities Qualification

  • Pre-Startup Check List
  • Documents Commissioning
  • Technical Support During Commissioning
  • Qualification Strategy
  • User/ Functional Requirements Specifications
  • IQ/ OQ Plans/ Protocols/ Reports
  • Maintenance and Operations
  • SOP’s development and on-site training

Quality Control

Labs

  • Methodology Transfer and Validation
  • Validation and Training in Chromatography software
  • System Configuration / Customization to reduce cycle time in documentation process
  • Data Migration
  • System support
  • SOP’s development
  • Documentation Review of analytical data in compliance with GMP’s, Federal and State regulatory requirements
  • SME in the most popular Chromatography Data System Software

Process &

Cleaning Validation

  • Process Validation Life Cycle
  • Gap Analysis and Audit validation protocols
  • Cleaning Validation programs for multi-product equipment
  • Development of Sampling Plans for cleaning processes
  • Provide laboratory services in the area of cleaning validation
  • Testing of samples including rinse/swab recovery and dirty equipment studies

Equipment

Qualification

  • 21 CFR Part 11 Assessment and Remediation
  • In-depth Computer Life Cycle Validation Strategy/Master Plan
  • User/Functional Requirements Specifications
  • IQ/OQ Plans/Protocols/Reports
  • Maintenance Validation
  • SOP’s Development, Training and Implementation
  • Backup, Security, Disaster and Recovery
  • Periodic System Review
  • Maintenance and Operations
  • SOP’s development and on-site training
  • Change Control
  • Vendor Audits
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