IQ OQ PQ Validation Documentation Services – GMP & GLP Compliance | UP Scales

Ensure Regulatory Compliance & Data Integrity with Expert Qualification Protocols

In today's highly regulated industries, installing a new piece of equipment isn't enough. You must prove it is installed correctly, operates as intended, and consistently performs its specific tasks within predefined limits. This is where Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) come in.

UP Scales provides comprehensive, turnkey IQ, OQ, and PQ Documentation Services for weighing and measuring equipment. We don't just sell you precision instruments; we provide the critical documentation you need to satisfy strict FDA, WHO-GMP, ISO, and other regulatory audits, ensuring your operations are always inspection-ready.

What Are IQ, OQ, and PQ? The Pillars of GMP Compliance

Validation might seem complex, but it breaks down into three logical, sequential phases. Think of it as building a case to prove your equipment is trustworthy.

1. Installation Qualification (IQ) - "Is it installed correctly?"

The IQ verifies that the equipment has been delivered, installed, and configured correctly according to the manufacturer's specifications and your facility's requirements. It's about the "static" state of the equipment.

Our IQ Documentation Includes:

1. Verification of model & serial numbers against purchase order.
2. Check of all components received against the shipping list.
3. Verification of proper installation environment (power supply, space, ambient conditions).
4. Confirmation of installation by a certified engineer.
5. Documentation of calibration certificates of installed equipment.
6. A complete summary report with any deviations noted.

An IQ proves you started with the right equipment in the right place.

2.) Operational Qualification (OQ) - "Does it operate correctly?"

The OQ tests the equipment's functionality to ensure it operates as intended across its entire specified range. It challenges the equipment's "dynamic" functions without using your actual product.

Our OQ Documentation Includes:

1. Verification of all operational functions (tare, unit switching, printouts, connectivity).
2. Testing of accuracy and precision using certified traceable weights across the entire weighing range.
3. Challenge tests for reproducibility (repeatability) and intermediate precision.
4. Testing of alarm functions and data security features.
5. Software version verification and access control checks (if applicable).
6. A detailed report with raw data, results, and pass/fail criteria.

An OQ proves the machine can perform accurately under controlled conditions.

3. Performance Qualification (PQ) - "Does it perform with my specific product?"

The PQ is the final proof. It demonstrates that the equipment consistently performs the specific tasks it is required to do in your actual production environment using your specific materials and processes.

Our PQ Documentation Includes:

1. Protocol designed around your specific product and process parameters.
2. Testing over an appropriate number of cycles to prove consistency and reliability.
3. Use of actual or simulated product to test performance under real-world conditions.
4. Documentation proving consistent results meet all required acceptance criteria.
5. A conclusive report that ties the equipment's performance directly to your product quality.

A PQ proves the equipment works reliably in your hands, for your purpose, day after day.

Why is Validation (IQ/OQ/PQ) Mandatory for You?

1. Regulatory Requirement: FDA 21 CFR Part 11, EU Annex 15, WHO-GMP, and other global standards explicitly require validated equipment in pharmaceutical, biotech, medical device, and food manufacturing.
2. Data Integrity: Ensures the data generated by your equipment (e.g., batch records, quality control results) is accurate, reliable, and trustworthy.
3. Quality Assurance: Prevents costly errors, rejects, and recalls by ensuring your equipment is consistently reliable.
4. Audit Preparedness: Provides auditors with the objective evidence they need to see, making inspections smooth and successful.
5. Risk Mitigation: Formally documents that you have done your due diligence in ensuring product quality and patient safety.

The UP Scales Advantage: Your Partner in Compliance

We bridge the gap between equipment procurement and regulatory compliance.

1. Expertise You Can Trust: Our documentation is prepared by professionals who understand both metrology and regulatory requirements.
2. Customized Protocols: We don't use generic templates. Every IQ/OQ/PQ protocol is tailored to your specific equipment model, software version, and intended use.
3. Meticulous Execution: We perform all tests with NABL-accredited calibration weights traceable to national standards, ensuring undeniable accuracy.
4. Audit-Ready Documentation: We provide a clean, professional, and easy-to-follow documentation package that will satisfy even the most stringent auditors.
5. Complete Support: From drafting the protocols to executing the tests and finalizing the reports, we manage the entire validation lifecycle.

Our Validation Process:

1. Consultation: We understand your equipment, process, and regulatory needs.
2. Protocol Drafting: We prepare the IQ, OQ, and PQ protocols for your review and approval.
3. Execution: Our qualified engineers perform the on-site testing and data collection.
4. Reporting: We compile all data into a final summary report, highlighting compliance.
5. Archiving: We provide you with both hard and soft copies for your quality system archives.