QMRC Implementation
ARD Scientific LLC offers services in the areas of Quality Management and Regulatory Compliance systems design, implementation and re-engineering. We work with the client to determine the scope, exigency, and complexity of the project. Then, the client is offered a choice of several packaged services that range from the full- service Quality Management and Regulatory Compliance Systems design and Implementation to the economical Standard Operating Procedures (SOPs) development and writing. Also, the client may choose services a la carte, or create a custom package consisting of any services/packages listed bellow:
ARD-DI1: GLP System Design and Implementation
Full-service project that is designed to assist research and development organization to transition into GLP environment. The following are included services:
- Development of strategic and detailed transition plans
- Writing of critical policies, SOPs, and guidelines
- Training of all staff members (all applicable to GLP Training plus management, study director, and IT training)
- Interim QA management (during and up to 1 year after implementation)
- Auditing and qualification of key vendors and suppliers during and up to 1 calendar year after implementation)
- 21 CFR Part 11 assessment Validation and CSV management (during and up to 1 year after implementation)
- Permanent QA staff recruitment assistance (during and up to 1 year after implementation
ARD-DI2: GCP System Design and Implementation
Full-service project that is designed to assist research and development organization to transition into GCP environment. The following are included services:
- Development of strategic and detailed transition plans
- Writing of critical policies, SOPs, and guidelines
- Training of all staff members (all applicable to GCP training plus management, monitors, IT, and investigator training)
- Interim QA management (during and up to 1 year after implementation) more>>
- Auditing and qualification of key vendors, suppliers, and selected investigators during and up to 1 calendar year after implementation) more>>
- 21 CFR Part 11 Assessment Validation and CSV management (during and up to 1 year after implementation)
- Permanent QA and monitoring staff recruitment assistance (during and up to 1 year after implementation)
ARD-DI3: GLP or GCP QA System Design and Implementation
Limited-scope project that is deigned to assist research and development organizations to implement GLP or GCP compliant Quality Assurance organization. The following are included services:
- Development of strategic and detailed QA plans
- Writing policies, SOPs, guidelines for QA Training of QA staff
- Interim QA management (during and up to 1 year after implementation) Auditing and qualification of key vendors, suppliers, and selected investigators during and up to 1 calendar year after implementation)
ARD-DI4: GLP or GCP SOPs
Limited-scope, most economical design and implementation project that is designed to assist research and development organizations to implement critical policies, SOPs, and guidelines that are required /expected by the FDA/ICH. The following are included services:
- Review and assessment of existing policies, SOPs, and guidelines (if available)
- Writing/revising policies, SOPs, guidelines
ARD-RDI: GLP/GCP System Re-design
Limited-scope project that is designed to assist GLP/GCP regulated organizations to re- resign and streamline their processes. The following are included services:
- Review and assessment of existing GCP/GLP systems
- Development of strategic and detailed re-design plans
- Revising/writing policies, SOPs, guidelines, as applicable Training/re-training of staff, as applicable
- Auditing/re-auditing and qualification/requalification of vendors, suppliers, and investigators, as applicable.