Validation and Qualification Services
- Validation Life Cycle Methodology
- Standard Operating Policy and Procedure Development/Implementation
- Quality Assurance Planning
- Validation Gap Assessments
- Validation Master Planning
- Process Validation
- Equipment Qualification
- Validation Protocol Optimization
- Protocol Development and Execution
- Documentation Management (EQ, DQ, IQ, OQ, PQ, and Final Reports)
- Change Control
- Re-Validation Planning
- Critical Facility and Utility Qualification / Validation (Water, Steam, Gases, Compressed air, Temperature, Humidity)
- Environmental Monitoring Planning and Execution (Particulate Matter Control Planning, Sampling and Analysis Plans, Analytical Data Review)
- Cleaning Validation
- Corporate On-site Training
- Computer and PLC System Validation
Software Lifecycle Support
Focus capabilities include the development and implementation of Software Lifecycle Documentation, system configuration documentation, change control documentation, and validation protocols. 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 caregivers 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 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.
Quality Assurance Planning
Focus capabilities include assisting senior management with setting quality objectives, defining the operational and/or quality system processes and the resources needed to fulfill the objectives, establishing performance indicators, and the communication and implementation of the established objectives.
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 Qualification and Process Validation
Focus capabilities include development of equipment qualification and process validation protocols for various types of equipment including testing equipment, vision systems, CNC machines, packaging equipment, molding machines, and injection systems. Focus also provides development of equipment qualification and process validation plans, SOPs, protocols, and reports. Focus provides personnel and equipment to execute qualification and 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.
Response to Regulatory Body Actions
Focus assists our clients with their response to agency actions including inspection observations, 483s, warning letters, and notices of violation (NOV). Focus assists with identifying and addressing the underlying issue, developing approaches to resolve the issue, preparing the remedial action plan and schedule, monitoring progress and reporting of the selected solution, testing the solution, and evaluation of completeness.
Nonconformance and Complaint Management
Focus capabilities include assisting clients in the investigation, development of corrective action, and the management and tracking of complaints and nonconformance events.
Focus capabilities include the development of document change control procedures
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.
Focus capabilities include the development of design document control procedures.
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.
Risk Assessment / Risk Management Services
The FDA’s 21st Century Initiative is intended to integrate quality systems and a risk management approach into existing systems. Focus provides services and tools to assist clients in implementing a Risk Assessment / Risk Management Program within their company. In addition, Focus can help develop quality policies on risk assessment for your company, and then revise any necessary existing guidance documents and SOPs.
Corporate On-Site Training / Seminars
Focus Compliance & Validation Services personnel are experienced trainers and provide training courses on-site for numerous topics. A Focus CVS consultant currently serves as an instructor on AAMI’s faculty.