Projects

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IT/QUALITY DOCUMENT SYSTEM (QDOCS) ​ APPLICATION LEVERAGING ​ COMPUTER SOFTWARE ASSURANCE (CSA) CONCEPTS

CASE STUDY

A privately held biotechnology company developing transformative cell therapies needed to build the technology foundation to be IT, Quality and Computerized Systems compliant. Goals included: ​

Emerging Technologies and ​ Process Improvement​

CASE STUDY

Goals included: Establish a “new” technology platform in which to assess, evaluate and respond to demand in a more effective, efficient, and responsive manner. The objectives were to:​

Computer Software Validation (CSV) Implementation

CASE STUDY

Computer Software Validation Implementation Goals:

Quality Control (QC) Equipment Validation ​

CASE STUDY

A large Drug/Pharma Contract Manufacturing Organization (CDMO) selected RCM to provide a solution to their Quality Control (QC) Equipment Validation challenges.

Clean Room Assessment and Compliance ​

CASE STUDY

A major pharmaceutical selected RCM to provide advisory services to senior management on how to prioritization GMP activities and related tasks.

Quality Remediation Program

CASE STUDY

A North American Pharmaceutical Company engaged with RCM to assist in developing a Quality Remediation Program to address current quality issues. The objectives were to improve processes, integrate new methods and techniques, and build a Quality Culture of continuous improvement. 

Validation and Compliance Assessment

CASE STUDY

A digital marketing and technology company selected RCM to assess their validation and compliance methods in relationship to the new FDA Computer Software Assurance (CSA) Guidance.

Governance and Data Protection

CASE STUDY

A digital marketing and technology company selected RCM to assess their validation and compliance methods in relationship to the new FDA Computer Software Assurance (CSA) Guidance.

Validation and Compliance Assessment

CASE STUDY

A digital marketing and technology company selected RCM to assess their validation and compliance methods in relationship to the new FDA Computer Software Assurance (CSA) Guidance.

Bill Gargano

Group SVP