validation, cgmp, current, good, manufacturing, practice, compliance, service, services, consultancy, project management, process rationales, user requirement specifications (URSs), traceability matrices, reviews, assessments and audits, compliance reviews by email, remedial action plans, site validation packages, good engineering practice, GEP, policies, policy, validation master plans, VMPs, validation, plans, VPs, design, installation, operational performance qualification, DQ, IQ, OQ, PQ, computer systems process validation, cleaning validation, CGMP and validation training, standard operating procedures, SOPs
  ABOUT US
 
SERVICES
Our project staff and contract personnel have successfully demonstrated time and again their skills in delivering all manner of validation and CGXP compliance services including:

  • Consultancy
  • Project Management
  • Process and Production Rationales
  • User Requirement Specifications (URSs)
  • Traceability Matrices
  • System Definitions
  • Risk-based Compliance Guidance
  • Compliance Advice by Email
  • Gap Analysis and Remedial Action Plans
  • Site Validation Packages
  • Validation and Good Engineering Practice (GEP) Policies
  • Validation Master Plans (VMPs) and Validation Plans (VPs)
  • Design, Installation, Operation(al) and Performance Qualification (DQ, IQ, OQ, PQ)
  • Computer Systems Validation
  • Process Validation
  • Cleaning Validation
  • CGXP and Validation Training
  • Standard Operating Procedures (SOPs)

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