SAVIS, Inc. Validation Services

The experienced validation team of engineers and scientists at SAVIS, Inc. are trained to develop a complete validation package that provides confidence that the system or process is under control. A typical validation package developed by SAVIS, Inc. includes such documents as a validation master plan, qualification protocols, test plans, manuals, procedures, etc. However, all customized packages fit the particular needs and formats of the client. The SAVIS, Inc. validation team has provided services in various disciplines of the regulated industries. In addition, special teams network with the industry through seminars, meetings, and review of published releases to ensure that the practices and procedures are up to date with the current regulatory requirements. SAVIS, Inc. personnel have also sponsored and performed seminars and training on validation.

The professionals at SAVIS, Inc. are available for consultation on a broad range of validation topics, such as:

	Equipment qualification
	Software validation
	Facility and environment qualification
	Electronic Document Management Systems
	Process validation
	Cleaning validation
	Sterilization
	Lab equipment qualification
	Lyophilization
	Laboratory test method validation
	Bulk Manufacturing
	Vendor qualifications
	Procedure qualification
	other services

The following is a partial list of SAVIS, Inc. projects associated with validation:

Centeon - Kankakee, IL Plasma Manufacturing

Developed and Executed Computer Validation Qualification Protocols for Building Monitoring Systems, a Laboratory Information Management Systsem, Filter Integrity Testers, Water for Injection Control Systems, Lyophilization Process and Steam in Place Cycles, and Various Other cGMP Related Systems.

Project Involved Working with a Project Team Consisting of Representatives of the Engineering, Validation, Quality Assurance, Regulatory, and Manufacturing Departments.

Centeon - Kankakee, IL Plasma Manufacturing

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.

Confidential Client -

Execution of Facility Commissioning Documents for Reverse Osmosis Water System, Water for Injection System, Pure Steam System, Compressed Air System, Nitrogen Gas System, Terminal Sterilizer and Laboratory HPLC Systems with the associated Client/Server Network.

Development of Facility Validation Documentation Including Equipment Specifications, Standard Operating Procedures, and Qualification Protocols for the HVAC System, Reverse Osmosis Water System, Water for Injection System, Pure Steam System, Compressed Air System, Nitrogen Gas System, and a Terminal Sterilizer.

Confidential Client -

Cleaning Validation Study to Remove Residues from Compounding Room Tanks and Transfer Lines.

Project Included Determination of the Residue Removal Method, Development of a Swabbing Procedure, and Determination of the Detergent for Regular Use.

Confidential Client -

Development of Software Validation Protocols for MP2 Quality Control Software, Microbiology Lab Equipment Software, and a Waters Corp. HPLC System Client/Server Network.

Aviron, Inc. Mountainview, CA Biomedical Division

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.

Packaging Coordinators, Inc. Philadelphia, PA Pharmaceutical Manufacturing

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

North Safety Products, Providence, RI Pharmaceutical and Medical Devices

Developed Acceptance Test Protocol for a New Deionized Water System

Project Included: Specification Development, Data Collection, and Protocol Development for the New Purified Water System.

Aviron, Inc. Mountainview, CA Biomedical Division

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.

North Safety Products, Providence, RI Pharmaceutical and Medical Devices

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.

Confidential Client -

Developed Acceptance Test Protocols for New Systems.

Project Included: Specification Development, Data Collection, and Protocol Development for Filling Machines, New Facility, and HVAC System. In addition, the Protocols were Executed and Detailed Punch Lists were Developed to Provide Documented Closure of any Open Issues Prior to Validation.

Confidential Client -

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.

North Safety Products, Providence, RI Pharmaceutical and Medical Devices

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, 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.

Confidential Client -

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.

North Safety Products, Rockford, IL Pharmaceutical and Medical Devices

Developed Equipment Specification Files for the Process Equipment that no Longer had Manufacturer Documentation Existing. The Process Equipment was used for the Manufacture of Bio-indicators, Liquid Ampules and Vials, Blister Packs, Swab Application Devices, and Glass Cutting Operations.

Project Included Automation of Ampulizing Process to Improve Process Control. In addition, Qualification Protocols were Developed and Executed to Demonstrate that the Improved Process would Remain in a Validated State in a Manufacturing Environment.

Confidential Client -

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

SoloPak Medical Products, Inc. Elk Grove Village, IL Pharmaceutical Operation -

Developed, Executed, and Certified Qualification Documentation for the Control of Seventeen Manufacturing Systems. These Control Qualifications were Independent of the Equipment Installation and Operational Qualifications.

Systems included: Water Pretreatment, WFI and other Utilities, Component Processing and Sterilization, Automatic Batch Compounding, Automated Inspection, Labeling, Packaging and In-Process Quality Monitoring Systems.

SoloPak Medical Products, Inc. Elk Grove Village, IL Pharmaceutical Operation -

Developed and Executed Validation Protocols for Syringe Inspection Process.

Project Included: Requirement Identification for Software Security Levels, Development of Standard Operating Procedures, and Development of Software Specifications for Product Enhancements.

SoloPak Medical Products, Inc. Chicago, IL Pharmaceutical Operation -

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.

Confidential Client -

Provided Integration and Validation Support using an Enterprise Document Management System (EDMS) and Tools. The EDMS managed documents with a variety of formats, including text and CAD documents, and integrated the document management across multiple sites.

Parke-Davis, Co. Fajardo, PR Pharmaceutical Operation -

Designed, Installed, Qualified, and Drafted Software and Hardware for New Nitrostat Marchesini Cartoning Machine.

Project Included: Upgrading the Control of a Conveyor and Accumulation Table Line. The Upgrade Enabled the System to Use Either of Two Cartoning Machines Based on the Type of Product Selected at the Main Line Operator Interface Terminal (OIT). Added Graphics and Alarm Updates to the OIT, as well as a One-Touch, Automatic Enabling System. The Enabling System would only Operate the Correct Cartoner for the Product Type Selected.