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.
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.
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.