Milli-Q® Qualification Program & Validation Procedures for Regulated Laboratories
Qualification Program: Validate your Water Purification System
We offer a full Qualification Program for your water purification system in order to facilitate laboratory validation procedures and ensure your system is fully compliant when audited. Our Qualification Program is designed for laboratories in regulated environments who must follow guidelines such as cGMP and GLP. The program includes:
- Qualification workbooks with Installation Qualification (IQ), Operational Qualification (OQ), Maintenance Procedures (MP), and examples of Performance Qualification (PQ) files.
- Certificates of Conformity, and Quality and Calibration certificates in support of compliance with GLP and cGMP.
All protocols are carried out by our specially trained and certified field service engineers. The Qualification Program can be ordered as a separate item or as part of a Milli-Q® Service Pharma™ Plan.
Support Compliance and Extend the Lifetime of your Water Purification System
Milli-Q® Service Pharma™ Plans not only address your compliance and specification requirements, but also provide yearly preventive maintenance procedures, better budget control, and rapid solutions in case an issue should arise. Pharma Plans cover all elements required for full system requalification, including:
- Qualification protocols: Requalification (OQ and MP) procedures for demonstrating compliance with regulations; Official procedures developed by compliance experts.
- Maintenance procedures (MP): Auditable service reports for full traceability.
- Qualification test equipment: All test equipment needed for qualification is calibrated according to metrological norms with traceability to the international standards.
Compare Plans to Match your Application, Compliance and Cost Needs
The comparison table below illustrates the differences in coverage between our 3 Pharma service agreements. Our Service Total Pharma™ Plan provides the most comprehensive coverage, allowing you to avoid untimely extra costs and prevent downtime, while also ensuring you are fully compliant when audited.
Milli-Q® Service Pharma Plans |
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Advantages of Milli-Q® Service Agreements
- Priority customer status – For any requests, including service visits and parts delivery.
- Technical support hotline – Unlimited access to our in-house support experts who can diagnose, investigate and solve issues, and schedule visits.
- Quality certified & harmonized expertise – Only specialist factory-trained field service engineers repair and maintain our water purifier systems in compliance with our worldwide auditable SOPs.
- Genuine spare parts – Produced in our ISO 9001-certified manufacturing site; Certificate of Conformity available for most parts.
- Preventative maintenance visit – Includes a scheduled comprehensive check-up of all system parameters, replacement of aging connections and tubing with our Maintenance Kit, standardized visit report, and traceable record of care.
For environments not requiring qualification and validation, our classic Milli-Q® Service Plans are available.
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