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 SAVIS Validation/Commissioning Department is committed to Quality Assurance. From basic system checkouts, verification testing and integrated commissioning to complete installation, operational and performance qualification; the SAVIS team provides services in the following areas to fit the client's requirement:

• - Facility/Utility/HVAC
• - Process and Lab equipment
• - Packaging and Inspection equipment
• - Computer
• - Cleaning
• - CIP/SIP
• - PRocess Validation
• - FMEA/PFMEA

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
• - PRocess Validation
• - Sterilization
• - Lab Equipment Qualification
• - Lyophilization
• - Laboratory Test Method Validationn
• - Bulk Manufacturing
• - Vendor Qualifications
• - Procedure Qualification