Consulting Services to the Blood and Plasma Industry

//Consulting Services to the Blood and Plasma Industry
Consulting Services to the Blood and Plasma Industry2018-08-02T21:30:57+00:00
Focus Compliance & Validation Services provides engineering and consulting services to the human blood and plasma collection industry. These services include the implementation of systems, procedures, and documentation to meet the FDA Quality System regulations affecting the blood and plasma industry. Focus has extensive expertise in providing consulting services in the area of Quality System Regulation, Regulatory Compliance, Validation and Qualification Services, Computer Validation, and On-Site Training.

Quality Management System, Validation and Qualification Services

  • Donor Management System Validation
  • Standard Operating Policy and Procedure Development/Implementation
  • Equipment Qualification
  • Freezer Validation
  • Documentation Management
  • Internal Auditing Services
  • Corporate On-site Training
  • Computer and PLC System Validation

Donor Management System Validation

Focus capabilities include the development and implementation of Donor Management System (DMS) validation planning documentation, system configuration documentation, change control documentation, and validation protocols (IQ/OQ/PQs). During development of written procedures, Focus interacts with all stakeholders to ensure that written procedures adequately address regulatory requirements, customer requirements, system limitations, and risk to both donors and patients.

Standard Operating Policy and Procedure Development/Implementation

Focus capabilities include the development and implementation of standard operating procedures and other procedures required for daily production. During development of written procedures, Focus interacts with all stakeholders to ensure that written procedures adequately address both regulatory requirements and practical limitations or requirements of the affected equipment and systems.

Validation Gap Assessments

Focus capabilities include performing Validation Gap Assessments used to identify deficiencies in the validation programs.

Validation Master Planning

Focus capabilities include development of Master Validation Plans (MVPs) for an entire facility or project/system specific MVPs. To ensure proper development of MVPs, Focus works with both validation and quality team members to determine equipment, and/or systems that will require validation, evaluate risks associated with each component, determine when revalidation will be required, and develop a strategy to implement validation.

Equipment Validation

Focus capabilities include development of equipment validation protocols for various types of equipment including freezer validation. Focus provides development of validation plans, SOPs, and validation protocols. Focus also provides personnel, and equipment to execute validation protocols.

Documentation Management

Focus capabilities include the development of document management procedures for either paper or electronic records and the conversion of paper document management to electronic document management.

Internal Auditing Services

Focus capabilities include internal auditing services to clients including auditing of procedures, documentation, and records management.

Corporate On-site Training

Focus capabilities include providing onsite training material and onsite training sessions for a variety of topics, including site specific SOPs, cGMP, environmental monitoring, etc.

Computer and PLC System Validation

Focus capabilities include assisting clients with risk analysis, validation planning, documentation preparation, and protocol execution required to efficiently and effectively qualify computer and PLC systems.