Christopher Townsend
Data Integrity Specialist
Validation Consultant
Pharmers LLC
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
Leverage
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.
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