The Story of FSCS
Our Beginnings
FSCS was founded by a group of passionate engineers who saw a need for innovative engineering solutions in the industry.
Their vision is to provide exceptional consultancy services tailored to the dynamic needs of the Pharmaceutical, Biotechnology, and Medical Device industries.
Our Growth
Established in the vibrant landscape of Florida, our journey began with a commitment to foster a familial atmosphere while delivering cost-effective solutions. From our humble beginnings, we have steadily grown into a trusted partner, renowned for our dedication to personalized attention and unwavering excellence.
Our Values
Our values of integrity, innovation, and client-centricity have been the cornerstone of our success, guiding us as we expand our expertise across a spectrum of critical domains.
At FSCS, our enduring commitment is to surpass expectations, ensuring the seamless and successful completion of every project we undertake.
The FSCS team specializes in many areas
Change Control Management Services
Batch Record Review and Revision Services
Change Control Management Services
- Creation and completion of change controls for any company change, be it equipment or process related.
- Thorough review of change controls to ensure compliance with regulatory standards.
- Expert handling of CAPAs (Corrective and Preventive Actions), Non-Conformances, Deviations, and Investigations to address any issues promptly and effectively.
Documentation Management Solutions
Batch Record Review and Revision Services
Change Control Management Services
- Specialized services in maintaining comprehensive documentation that aligns with current FDA regulations and policies.
- Assistance with Change Control documentation, including creation, completion, and review.
- Management of CAPAs, Non-Conformances, Deviations, and Investigations documentation to ensure accuracy and compliance.
Batch Record Review and Revision Services
Batch Record Review and Revision Services
Batch Record Review and Revision Services
- Collaborative efforts between experienced engineers and operational staff to enhance Batch Record instructions, minimizing errors and citations.
- Streamlining of Batch Record processes to reduce data entries and improve clarity, utilizing specialized techniques tailored to each client's needs.
Project Management Expertise
Standard Operating Procedure (SOP) Development and Revision
Batch Record Review and Revision Services
- Comprehensive support throughout project lifecycle, including planning, scheduling, task management, milestone planning, gap analysis, and reporting.
- Leadership of multi-functional teams to ensure successful project deliverables.
- Specialization in Project Management for Validation activities, Technology Transfer, and Aerospace design projects.
Standard Operating Procedure (SOP) Development and Revision
Standard Operating Procedure (SOP) Development and Revision
Standard Operating Procedure (SOP) Development and Revision
- Extensive experience in preparing and revising SOPs for regulated industries such as Medical Device, Pharmaceutical, and Aerospace.
- Tailored SOP solutions covering areas such as Quality Assurance, Maintenance, Environmental standards, SQM (Supplier Quality Management), Quality Control, Manufacturing, and Supply Chain.
Validation Services
Standard Operating Procedure (SOP) Development and Revision
Standard Operating Procedure (SOP) Development and Revision
- Comprehensive support in various validation activities, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Commissioning, Re-Qualification, Clean Room validation, Equipment Validation, Temperature Mapping, and Statistical Analysis.
- Cost-efficient services designed to meet organizational validation standards, delivered by a team with extensive experience and expertise in the field.