System and Process Validation or Qualification

Lachman Consultants is available to help evaluate the adequacy of products, equipment, and facility. Lachman’s consultants provide expert, unbiased assessments that help ensure that strengths are recognized and weaknesses are addressed.

Lachman delivers both strategic recommendations and tactical, front-line support through services, including programmatic assistance, validation/qualification activities, and computer systems validation.

Programmatic Assistance

  • Validation/qualification policies, procedures, protocols, and master plans
  • Technology transfer programs—including processes, analytical methods, and changes
  • Staff training for ongoing validation programs
  • Program assessments
  • Process simulation programs (i.e., aseptic processing media fills)

Validation/Qualification Activities

  • Validating/qualifying computerized systems and electronic records; manufacturing, packaging, and labeling processes; cleaning, sanitation, and sterilization systems and processes; and facilities, critical utilities, and equipment
  • Validating analytical methods
  • Qualifying analytical equipment

Computer Systems Validation and 21CFR Part 11 Compliance

Development and/or implementation of:

  • Validation of process, equipment, instrumentation, analytical methods, utilities, facilities and computer applications
  • Risk-based validation strategies
  • User requirements, functional and design specifications
  • Protocols, reports and test cases for IQ, OQ, PQ
  • Data migration and verification
  • 21 CFR Part 11 System compliance assessments and training, including electronic signatures
  • Infrastructure (LAN and WAN) qualification
  • Specific requirements for analytical methods validation
  • Electronic tracking systems for validation

Development of support systems affecting validation, including:

  • Change control
  • Configuration management
  • Retrospective validation
  • Electronic signature certification and policy
  • IT security procedures
  • Patch installations, including virus/security
  • Periodic reviews
  • Electronic data integrity assessments