Compliance Management Systems
Compliance Management Systems, Inc. is a consultancy focused on enabling the life sciences sector since 2007. Headquartered in Orange County, California, the company specializes in GxP compliance assurance, data integrity, and validation services for pharmaceutical, biotech, and medical device companies worldwide. They offer CSV subscription services, data integrity assessments, remediation planning, and training, supporting organizations of all sizes to meet regulatory requirements and improve quality systems.
Industries
Nr. of Employees
small (1-50)
Compliance Management Systems
Products
Data integrity gap-analysis tooling
Tooling used to efficiently generate gap analyses between regulatory expectations and an organization's policies, procedures and practices to support remediation planning.
Pre-configured GxP cloud CRM application solutions
Pre-configured cloud-hosted CRM/application components tailored and validated for use in regulated environments to provide interim and long-term controls.
CSV Program Subscription
Outsourcing model for CSA and GAMP 5 SE aligned Computer Software Validation (CSV) activity, supporting program establishment, system inventory, risk assessment, and remediation planning.
CSA/CSV Program Development
Program development services providing support to build and improve internal programs governing and controlling system life cycle processes.
Data Integrity Assessment and Remediation
Consultancy and tooling service to assess data integrity programs, perform gap analyses between regulatory expectations and internal procedures, and provide remediation planning.
CSA/CSV Project Services
Project-level validation services designed to right-size validation efforts with appropriate, documented, and tailored risk-based approaches.
Data integrity gap-analysis tooling
Tooling used to efficiently generate gap analyses between regulatory expectations and an organization's policies, procedures and practices to support remediation planning.
Pre-configured GxP cloud CRM application solutions
Pre-configured cloud-hosted CRM/application components tailored and validated for use in regulated environments to provide interim and long-term controls.
CSV Program Subscription
Outsourcing model for CSA and GAMP 5 SE aligned Computer Software Validation (CSV) activity, supporting program establishment, system inventory, risk assessment, and remediation planning.
CSA/CSV Program Development
Program development services providing support to build and improve internal programs governing and controlling system life cycle processes.
Data Integrity Assessment and Remediation
Consultancy and tooling service to assess data integrity programs, perform gap analyses between regulatory expectations and internal procedures, and provide remediation planning.
CSA/CSV Project Services
Project-level validation services designed to right-size validation efforts with appropriate, documented, and tailored risk-based approaches.
Services
Gap analysis versus regulatory expectations, remediation planning and execution to address audit or inspection observations.
Design and implement CSA/CSV program SOPs, templates, and training to govern system lifecycle and validation activities.
Subscription model to maintain validated state of systems including inventory updates, periodic reviews, minor change support and continuous program maintenance.
Risk-based supplier qualification, vendor QMS assessment, and lifecycle documentation review to support validation reliance and reduce validation effort.
Provide subject-matter expert auditors to plan and execute internal audits focused on CSV, QRM and data integrity in accordance with client SOPs.
On-site CSA/CSV and GAMP5 training, program improvement workshops and project-level documentation workshops for stakeholders.
Gap analysis versus regulatory expectations, remediation planning and execution to address audit or inspection observations.
Design and implement CSA/CSV program SOPs, templates, and training to govern system lifecycle and validation activities.
Subscription model to maintain validated state of systems including inventory updates, periodic reviews, minor change support and continuous program maintenance.
Risk-based supplier qualification, vendor QMS assessment, and lifecycle documentation review to support validation reliance and reduce validation effort.
Provide subject-matter expert auditors to plan and execute internal audits focused on CSV, QRM and data integrity in accordance with client SOPs.
On-site CSA/CSV and GAMP5 training, program improvement workshops and project-level documentation workshops for stakeholders.
Expertise Areas
- Data integrity assessment and remediation
- Computerized system validation (CSV) and Computer Software Assurance (CSA)
- Risk-based validation and system risk assessment
- Supplier qualification and vendor auditing
Key Technologies
- Computerized System Validation (CSV)
- Computer Software Assurance (CSA)
- GAMP5 framework
- Risk-based validation methodology