Direct or Subcontract to Pharmaceutical Clients


  • Data Integrity Analysis
  • Software QA/CSV Consultant
  • Laboratory Instrument Validation
  • MES Configuration/Quality Reviewer

“Are your electronic records

trustworthy and reliable?"




"Is your GxP system's documentation complete?”


My key achievements


  • Experience on Consent Decree, Warning Letter, and Refuse to File Remediation Teams


  • Certification in GAMP® 5 Guide: a Risk-based Approach to Compliant GxP Computerized Systems by ISPE


  • Data Integrity training from industry leaders


  • Controlled gowning instruction by the Military and Commercial leaders


  • Laboratory System Representative for Pre-Approval Inspection by Federal and Foreign Regulators


  • Making systems better


My past achievements

guide my busines

making decisions. 


Let me protect you

and balance your

business needs.


Some of the help I can provide:

Part 11 / Data Integrity Consultations

 Data Integrity must be engineered into your systems.  I will perform the following tasks on your data producing equipment:

- assess current configurations with concise documentation

- provide recommendations on system's development and upgrade advice

Data Integrity Corporate Representative


I have experience assisting global corporations increase their data integrity maturity level while harmonizing policies across multiple sites.

Deep Data Dive / Data Integrity Authentication


I can trace your original data and the associated audit trails on multiple systems. 

Equipment Configuration Consultations  


Millions of dollars can be wasted by choosing the wrong path.  I provide advice when you are in the early stages of equipment purchase or setup.  I can help compare vendors and configurations with a full Risk Assessment and Mitigation report.

Get the best technology fit for your system use. 


Emergency Team Member and Additional Resource 


I can take on multiple roles rounding out your needs.  My diverse experience allows me to hit the ground running.  I can provide standalone documents, take on a project role or execute your internal validation documents and procedures.  I can get your project done in a lean and efficient way.

Validation Resource 


Computer System Validation - Author, executer or reviewer roles


I have experience with Manufacturing Execution Systems (MES), Enterprise Learning Management Systems (ELMS), Enterprise Resource Planning (ERP) Systems and their associated databases and interfaces.


Periodic Review - Computer System / Instrument


The frequency of performing Periodic Reviews should be dependent on the Complexity, Criticality, Novelty and Operating History of the computerized system.  I can help you establish a periodic review or perform it for you.


Instrument Validation Packages


Full system validation, and additional supporting documents.


Custom Documentation


I can capture a system's adherence to Data Integrity and Part 11 considerations


Corrective Action Remediation


I can help you draft corrective responses to address the root cause identified and help you assess the impact on your company's current procedures.

Serving the Greater Philadelphia area on a daily basis and available for travel.