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: ​

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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:​

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Computer Software Validation (CSV) Implementation

CASE STUDY

Computer Software Validation Implementation Goals:

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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.

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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.

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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. 

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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.

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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.
A close-up photograph of a vibrant, glowing light bulb suspended against a backdrop of a clear blue sky

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.