Copy0right 2003-2004
Miller Regulatory Consulting, Inc.
Last updated: 08/15/2009
              

 

  
  Miller Regulatory Consulting, Inc.
Services
Recent Computer Validation Projects
  Laboratory Information Management System (STARLIMS)  
  Chromatography Data System (Waters Empower and Waters Millennium32)
including the development of custom equations and reports		  
  Adverse Reaction Information System (ARISGlobal ARISg, ORACLE AERS)  
  Calibration management software (Blue Mountain Calibration Manager)  
  Electronic document management system (First Consulting Group FirstDoc)  
  UV-Vis and FTIR spectrophotometers (Thermo Electron VISIONSecurity, WinFIRST)  
  Microbiology Information Management System (Compliance Software Solutions MIMS)  
  PK/PD Modeling and analysis (Pharsight WinNonlin)  
  Clean Room HVAC monitoring and controls (Johnson Controls Metasys)  
  Scan-TVS Document Comparator  
  Spray dryer HMI (custom)  
  Server Qualifications for SAS operations  
  Network Infrastructure Qualifications  
  Embedded microcontroller systems (for custom systems)  
  Inventory Management System (for a custom-written system)  
Computer Validation
  Services cGxP QSR
Turn-key validation projects + +
  User Requirement and Functional Requirement Specifications + +
Vendor / Supplier Selection + +
Vendor / Supplier Audits + +
Risk Analyses + +
Design Documentation for existing systems + +
Perform code review for custom systems + +
Installation Qualification protocols +  
Write and Execute OQ/PQ (Operational and Performance Qualifications) +  
Installation documentation   +
Assist with writing and executing SDLC testing (unit, module, integration, stress, alpha, factory acceptance, site acceptance, user acceptance)   +
Prepare operational SOPs + +
Validation Summary Reports + +
Manage complex projects including all of the above tasks + +
 
All adapted to meet your SOPs and compliance culture  
21 CFR Part 11 Services
  Services  
  Part 11 Training  
  Compliance Assessment Plans  
  Risk Analyses  
  Remediation Plans  
  Compliance Review and Recommendations - GAP Analyses  
  Project Management  
     
Compliance Management
  Think about your company's compliance culture for a few seconds...  
  Is your company:  
 

  • ultra-conservative and willing to address and mitigate every possible risk regardless of cost?

  • operating under "zero 483 tolerance" and changing operations based on anything any investigator has ever said?

  • performing a risk analysis and committed to resolving risks with a proportional response in a clear timeframe?

  • watching the FDA Warning Letters and making changes based on what other companies are doing wrong?

  • waiting for the FDA to tell you what you are doing wrong?

 
  Every company has its own compliance culture, for better or for worse.  Too little attention to compliance can bring the FDA charging in, but going overboard in the name of compliance can be outrageously expensive! Some companies spend three times what most others are spending in the desire for more detailed computer validation documentation. Are they getting three times the value?  
  Where do you stand? 
Will your consultants be attentive to your existing culture? 
Will they recognize destructive behaviors in either direction and advise you accordingly? 		 
  Contact MRC to:  
  Evaluate compliance culture to industry norms or desired traits.
Report findings and recommendations.
Work with management to achieve the desired compliance cultural changes.		  
     
Seminars and Training
  Training may be performed in classes ranging from 30 minutes to all day training seminars or in multi-day hands-on workshops.  Some typical examples are listed below.  Contact us to discuss how MRC can meet your specific training needs. info@miller-rc.com  
     
  Part 11 for Senior Management (Pres. VP, Dir.)  
  Part 11 for Assessment and Compliance Teams  
  Why SOP Compliance is Critical to Part 11 Compliance (for all staff)  
  Regulatory Issues for Life Sciences Customers (for Vendors / Suppliers)  
  Constructive and Destructive Regulatory Compliance Corporate Cultures  
  Computer System Validation for Senior Management (Pres., VP, Dir.)  
  Computer System Validation for QA Professionals  
  Computer System Validation and Regulatory Issues for IT Professionals  
  Overview of Computer System Validation  
  The System Development Life Cycle and FDA Expectations  
  SOPs You Can Live With  
  Reducing Validation Testing Time Using a Chromatography Peak Simulator  
     
  All seminars and training sessions may be scaled to suit the target audience, available time, and desired interaction levels.  MRC will customize seminar and training sessions to meet your needs.