HPFM, Inc.

Formed in 1994, HPFM Inc. provides implementation and validation assistance for computerized systems in regulatory environments. All HPFM personnel have over 20 years of pharmaceutical experience and have implemented and validated several successful LIMS (Laboratory Information Management Systems). HPFM can participate in all phases of LIMS implementation and validation, including:

Strategy

• Defining the overall scope of validation and plans for each phase
• Defining the scope and phases of implementation
• Identification of SOPs required
• Requirements Definition

Design

• Technical system set-up (instances, naming standards, directories, security)
• Validation documention
• Implementation specifics
• Training: processes and documentation
• Reports
• Retrospective Analysis Systems (SAS-based)

Execution

• Database and configuration management
• SOP and validation plan writing
• Validation
• Report writing and installation
  
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