SAVIS, INC. - Services

The following is a partial list of SAVIS, Inc. service projects:

Quality Operations data review of automation validation documents. Included pre and post execution review of DeltaV automation validation. Required coordination with validation, engineering and system owner from document development through execution and to final reports.

Engineering, commissioning and implementing CIP cycles with their associated equipment.
Activities consisted of developing tank/line circuits and drilling/installing spray balls and other miscellaneous parts for proper coverage and cleaning of process lines and vessels. The project required tank dives for spray coverage testing where engineers would follow OSHA (Occupational Safety and Health Administration), EH&S (Environmental Health and Safety), Confined Space Entry, and LOTO (Lock Out Tag Out) procedures and regulations.

Performed engineering temperature mapping studies and commissioning tests on one blast freezer and seven (7) storage freezers used to freeze and store PCM (Phase Change Modules) used to maintain product temperature during shipment to the Puerto Rico Fill and Finish Facility.
Project included set-up and use of Kaye Validator 2000 data loggers to monitor freezer performance, data collection and analysis of most effective load configurations, and TOP creation and approval.

Managed Project Team for Implementation of Automated Environmental Monitoring System.
Project Included Management of Project Plan, Timeline, and Working Closely with the Various Disciplines to Implement the System in a Timely Fashion.
Project also Included Development of Requirements, Specifications, Detailed Drawings with Sensor and Controller Layouts, Man/Machine Interface Program Development, and Database Support with the Information Technology Department.

Engineering System Development and Material Management. Developed Detailed Specifications for Aseptic Manufacturing Components, Processes, and Materials.
Projects Included: Consultations with Suppliers, Collection of Data, and Documenting Results in an Approved Format.

Aseptic Manufacturing Material Flow Development.
Project Included: Definition of Procedures for Control of the Receiving, Incoming, Inventory, In-Process, and Shipping of Components and Materials. The Facility is Responsible for the Aseptic Manufacture and Control of Filled Syringes

Quality Assurance System Development for Aseptic Filling.
Project Included: Developed a Quality System for the Monitoring and Control of the Manufacture of Pre-Filled Aseptic Syringes. Developed Several Sampling and Inspection Plans for the Different Inspection Phases Including Incoming, In-Process, and Finished Goods. Developed Associated Documentation and Procedures to Provide Forward/Reverse Traceability for Product Delivery and Regulatory Recalls.

HVAC System and Deionized Water System Integration
Design, Purchase, Installation, Management, Documentation, and Qualification of a Clean Room Manufacturing Environment Including New Utilities, DI Water System, and Environmental Control System.

Designed, Developed, and Currently Maintain Financial Market Software with a Real-Time Data Link to the Major Financial Service Providers. The Software Manages Portfolios by Separating Strategies, Calculating Derivative Positions, and Logging Transactions to ODBC Compliant Databases. Configurable Reports Allow for Daily Account Reconciliation and Summarization.

Developed Cleaning Process and Validation Guidelines.
Project Included: Development of a Cleaning Lifecycle Flow Diagram, Review and Upgrade of Current Analytical Test Methods, Development of Cleaning SOPs for Various Pieces of Equipment, Method Determination of Acceptable Residue Limits, and Comparisons to Current Industry Standards.

The Initial Phase Included Development of the Process and Facility Validation Master Plan.
The Second Phase Included the Review and Development of Specifications and Qualification Protocols for the Facility, HVAC System, Laboratory Equipment, Purified Water System, Utilities, Label Room, Security Access System, Compressed Air, and Process Equipment.
The Third Phase Included the Execution of the Protocols and Development of Summary Reports. In addition, the Completion of the Process, Cleaning, and Test Method Validation was also Included in the Third Phase.

Development and Execution of Complete Facility Validation
The Initial Phase Included Development of the Process and Facility Validation Master Plan.
The Second Phase Included the Review and Development of Specifications and Qualification Protocols for the Facility, HVAC System, Laboratory Equipment, Purified Water System, Utilities, Security Access System, Compressed Air, and Process Equipment for Liquid, Powder, Tablet, and Capsule Products.
The Third Phase Included the Execution of the Protocols and Development of Summary Reports. In addition, the Completion of the Process, Cleaning, and Test Method Validation was also Included in the Third Phase.

Validation, Regulatory, and Engineering Project Management.
Project Included: Completion of a Compliance Enhancement Initiative for a Syringe Manufacturing Facility to Address Internal and FDA Regulatory Observations.
Systems Included: Automated Inspection, Water For Injection, Labeling, Label Reconciliation, Component Processing and Compounding.

Development and review of CBER (Center for Biologics Evaluation and Research) submissions for new and existing process control systems.

Developed and Implemented Software for Financial Market Monitoring and Predicting. The System Includes Real Time Online Market Communication, Derivative Calculations, Trend Predictions, and Configurable Functions. The Software is Designed to Run on Custom Personal Computers, Workstations, and Networks.

Designed, Installed, and Developed Documentation for the Hardware and Software of a Packaging Line Electronic Verification and Monitoring System.
Project included: Barcode Verification, Vision Systems, Laser Coding, Printing and Applying Labels, Production Reports, System Monitoring, Designation of Security Levels, and Label Management.

Designed, Installed, and Developed Documentation for the Hardware and Software of a Packaging Line Electronic Verification and Monitoring System on Lines 1, 3 and 4.
Project included: Barcode Verification, Vision Systems, Laser Coding, Production Reports, System Monitoring, Designation of Security Levels, and Label Management.

Rolaids Label Room Turnkey Project for a Roll Label Inspection/Counter System, a Cut Label Verification/ Counter System, and a Label Disposal System.
Project Included: Specification, Purchasing, Installation, Qualification, and Standard Operating Procedure Development for the Different Systems. Facility Design and Startup were also Included in the Project.