Program Features:                                                                                                                     Screen Shots

• Easy step by step process for completing and documenting corrective or preventive actions.
• Simple navigation using a "wizard" style interface, tabbed pages, or  menus
• Thorough documentation of the CAPA process from identification of the problem through verification and validation of the resolution
• Includes all essential elements of a fully compliant CAPA system: identification, evaluation, investigation, analysis, implementation, follow up and approval.
• Contains appropriate control and security tools for implementing current FDA Part 11 Compliance requirements:
  • Security: Users are assigned a unique UserId and password
  • User management: Four permission levels are available (Read only, User, Approval, and Administrator) which can be assigned by the Administrator. Appropriate functions and features of the program are available to the user based on the level of access assigned.
  • Audit Trails: A complete audit trail is maintained tracking additions, changes, and deletions. Includes time,date, user and changes made.
  • Electronic signatures can be applied to approve a completed Action.
• Multi-step Investigation procedures and Action plans allow assigning responsibility, due dates, progress, etc.
• Follow up Action items with implementation details: actions taken, documentation created or changed, completion dates, etc. 
• Link or import relevant documents to the specific Action or to individual Investigation Activities and Action Plan Tasks.
• E-mail Investigation Procedures and Action Plans to responsible parties or other recipients as necessary.
• Valuable forms and reports can be printed, emailed, or saved to popular formats. (see below for details).
  • Data collection forms
  • Identification, Remedial Actions, Investigations, Action Plans and various Action summaries are available for printing.
  • A complete hard copy documentation of the Action can be created.
• Spell Check data entry fields.
• Information is maintained in industry-standard XML format using customizable database model
• Export reports in PDF, MS Word, MS Excel, or text formats
• MS PowerPoint  training  program is included with the system, and also available for download
• Includes extensive online help

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System Requirements:

Computer: Intel® Pentium II 400MHz (or equivalent), 256Mb RAM, 10Mb free HDD space
Operating system: Windows® 98, ME, NT, 2000 or XP
Microsoft .NET Framework v1.1

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