Quality Systems
BioTechLogic can assist you with organizational activities, plans, policies, procedures, processes, and provide the resources associated with designing, implementing, and maintaining a quality system focused toward meeting customer satisfaction. BioTechLogic Inc. supports our clients' Quality Assurance departments by providing the following services:
Quality System Procedures
BioTechLogic can design and implement quality system procedures and instructions in accordance with corresponding regulatory requirements. Examples of quality system procedures and instructions include but are not limited to:
- Design and implement quality systems
- Standard operating procedures (SOP) and forms
- Detailed specification development
- Regulatory documentation preparation
- Quality Manuals
- Quality policy and objectives
Quality System Analysis and Improvements
BioTechLogic can provide advice the continuous improvement and analysis of your quality system. Examples of quality system analysis and improvement services include but are not limited to:
- Quality system analysis and improvements
- Quality system upgrades to new standards and requirements
- Corrective and preventive actions (CAPA)
- Failures, deviations, and out of specification (OOS) investigations
- Mitigation strategies and plans were deficiencies have been identified
- Quality Plans
- Quality Risk Management
- Quality Mapping
- GMP training
- Resource Management
BioTechLogic can provide additional resources to your quality assurance department to help achieve goals and deadlines by:
- Document review and identifying actions required to meet regulatory requirements and ensure product quality
- On-site support ensuring operational compliance and additional assistance during regulatory inspections
- Quality Assurance and Post-Market Compliance Audits