Specifications
17
IQ/OQ/PQ for Weighing Equipment in Production
IPac is designed to be consistent with the requirements
of GMP and other quality systems. Execution of an
IPac by a trained METTLER TOLEDO service representa-
tive delivers a self-contained solution for new equip-
ment qualification or for re-qualification of equipment that
is re-purposed, moved or lacks adequate documentation.
Benefits of outsourcing equipment qualification to us include:
• Achieving the qualified state and avoiding audit challenges
• Ensuring proper, compliant results using OEM protocols
• Reducing the time and expense of managing qualifications
IPac incorporates:
• IQ (Initial Qualification)
Performs and documents equipment installation
• OQ (Operational Qualification)
Initial calibration and user familiarization
• PQ (Performance Qualification)
Supports setup of SOPs
• MQ (Maintenance Qualification)
Establishes maintenance requirements
Compliance Services
Equipment Qualification
Computer System
Validation
Pharmaceutical, biotech, food and beverage manufactur-
ers are commonly subject to regulatory requirements
for equipment qualification and computer system valida-
tion. METTLER TOLEDO has qualification and valida-
tion protocols and documentation solutions that satisfy
the demands of the FDA and other regulatory bodies.
Consulting, Support and Protocols for Validation
The METTLER TOLEDO CSV Pac includes services and
protocols to ensure successful validation of our
FormWeigh.Net
®
or FreeWeigh.Net
®
solutions in a
regulated environment. The validation approach
begins with the first meeting, continues through pro-
cess analysis, writing of Functional Requirements
Specifications (FRS), risk analysis, and SOPs, con-
tinues with IQ and OQ, and culminates in a ready
for production, validated solution.
You benefit from our experience and standardized,
yet flexible approach by:
• Achieving validation faster and at lower cost
• Ensuring a dependable and maintainable system
• Establishing validation meeting audit requirements
The CSV Pac encompasses:
• Validation Support
Complete on-site consultation for all phases of validation
• Validation Manual 1
Qualification of METTLER TOLEDO as a vendor
• Validation Manual 2
Guidelines, forms and protocols for validation
www.mt.com/service
www.mt.com/validation
METTLER TOLEDO Worldwide Services