Validation
Services
AMT, Inc. offers a wide range of compliance and validation services for firms regulated by the FDA or required to comply with the code of Federal Regulations (CFR’s). New system projects as well as remediation services for legacy systems are provided as part of AMT’s validation capabilities.
Planning
§
Preparation
and documentation of validation plans and procedures
§
Preparation
of written protocols and test plans stating how validation will be conducted
o Test parameters
o Product characteristics
o Production equipment
o Definition of acceptable test results
§
System
Requirement Specifications
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System
Design Specifications
§
Standard
Operating Procedures
PQ - Performance Qualification
§
Verify
and document that equipment performs consistently within defined operating
parameters when subjected to real-use conditions of operation
§
Extremes
of the operating range as well as normal operating limits are challenged and
qualified
§
Repetitive
testing and documentation to demonstrate that the process or unit operation
will consistently meet specifications
OQ – Operation Qualification
§
Verify and
document that equipment or unit operation functions as specified
§
Verify and
document that equipment has the capability of operating within a broad range of
parameters including the required process parameter limits
§
Establish
parameters by objective evidence which result in operations that meet all
predetermined requirements
Computer System Validation
Computer
System Validation is the verification of performance quality and data integrity
within a system falling under regulatory requirements.
§
Software
Validation (Custom, Off-the-Shelf, PLC, PC, Operator Interface, MES, Data Base)
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Automation
Network Validation
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System
Verification and Supporting Documentation
§
Validation
Summary Reports
Batch Management
§
Production
Automation, Design, and Implementation Services for Electronic Batch Record
Systems (recommendations, evaluations, and configuration)
§
Recommend and
test process controls to ensure batch uniformity and conformance with
predetermined specifications
§
21 CFR 11 –
Electronic Records / Electronic Signature compliance
§
Validate
supporting GMP’s
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AMT, Inc.
560 W. 3rd St. • Jamestown, NY 14701 • (716) 488-9827 • Fax: (716) 664-2898
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