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Preparing for Validation

Our standards have been utilized throughout the industry and are kept up-to-date with the US and European Regulatory Agencies’ latest Regulations and Guidelines, along with supporting agencies publications and Industry practices.

Our Compliance Group can support you in the many areas of validation:
Equipment and Utility Validation
Cleaning Validation
Computerized Systems Validation
Sterilization and Sanitization Validation
Process Validation


1.Validation Master Plan
  A properly validated system starts with the introduction of the Validation Life Cycle described
  in our Validation Master Plan.  Our Standard Validation Master Plans are structured,

     a.to clearly define proper Validation/Qualification path for GXP relevant areas;
     b.to identify the background, facility, process, boundaries and critical systems;
     c.minimum requirements to assure a validated process;
     d.to define the specific test functions and acceptance criteria;
     e.and to define support systems and procedures to assure continued compliance
        throughout the systems validation lifecycle.

  Many Validation Master Plans have been developed by our compliance consultants and are
  available to apply to your process:

     a.Validation Master Plan - Facility & Equipment, Process
     b.Computerized Systems Validation (CSV) Master Plans
     c.Cleaning Validation Master Plan

2.Validation Procedures
  Our standard package of procedures includes basic procedures to assure compliance during
  the qualification.  These procedures are:

     a.Validation Overview,
     b.Good Documentation Practices,
     c.Protocol Review and Approvals,
     d.Preparing Qualification Protocols,
     e.Executing Qualification Protocols,
     f. Comments and Deviations,
     g.Preparing Summary Reports.

  Our compliance consultants have developed magnitudes of procedures for all processes,
  which are available for your review.

Preparing for Validation
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