Are you concerned about the FDA's Rule 21 CFR Part 11 and the EPA's CROMERRR?

Visit the government's sites:

	FDA
	EPA

When was the last time you checked the accuracy of your detector's wavelength?

How precise is the flow rate of your pump?

Does your GC, UV-Vis and FTIR spectrometer conform to manufacturer's specifications?

Laboratory instruments are coming under increasing scrutiny by the Food and Drug Administration (FDA), United States Environmental Protection Agency (EPA), and other regulatory agencies.

Increasingly, these agencies are requiring analytical instruments comply with appropriate codes and approved design intentions. Furthermore, if you are using analytical instruments for client applications, R&D, production, or QA/QC operations, these lab instruments require periodic testing to verify their suitability and accuracy because equipment performance deteriorates over time.

IQ OQ PQ/PV Validation

Assess, develop & implement compliance
at the level you need

Validation Home | Instruments We Validate
Validation Details | Multi-Vendor Validation

Our IQ OQ PQ qualification and validation programs (also referred to as IQ OQ PV by Agilent^®) help your company assess, develop and implement regulatory compliance at the level you need, including the FDA’s Rule 21 CFR Part 11 and the EPA’s CROMERRR.

As your partner, we can determine the level of compliance and validation appropriate for your company. We then customize our services to compliment your in-house compliance and qualification / validation programs, allowing you to optimize resources.

Our compliance consultants and engineers are experienced in Quality System:

	Assessment and Evaluation
	Development and Planning
	Master Plan Implementation and Review

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Our three-phase program allows you to pick the compliance level suitable to your needs.

	Phase I Regulatory Compliance Assessment: We examine and inspect laboratory guidelines; perform system and equipment reviews, and assist you through QA audits (pre-FDA inspections). We also provide compliance reviews and services for QC, manufacturing, and operations.
	Phase II Regulatory Compliance Development: We assist you in creating, modifying or enhancing the effectiveness of your Quality Programs.
	Phase III Regulatory Compliance Implementation: We assist you in executing the specifics of your compliance programs.

And as your regulatory compliance partner, we will design a solid strategy for future regulatory compliance objectives as well as provide comprehensive support in meeting instrument validation / qualification and regulatory documentation needs.

Our qualification / validation offers:

	Complete maintenance history, system history and inventory of components and documentation.
	Universal IQ, OQ, PQ template format.
	Verification of components' installation including electrical, plumbing, and communication connections.
	Verification of components' functionality, operation, and conformity to manufacturer's specifications.
	Performance verification of laboratory equipment for routine R&D, QA/QC, EPA, FDA, and client-compliance operation.
	Pre-scheduled and annual instrument qualification / validation programs matched to your company's needs and budget.
	Cost effective and fast turnaround for your laboratory equipment IQ, OQ, PQ verification.

Validation Home | Instruments We Validate
Validation Details | Multi-Vendor Validation

Selected by Amgen
for IQ OQ PQ Validation in California

Selected by Bayer
for On-Site Service & Repair and Validation

Qualification / validation services are competitively priced and held to the highest standards.

We validate clean rooms, instruments and equipment.

Some of the industries we provide IQ OQ PQ services for:

	Biotechnology
	Pharmaceutical
	Chemical
	Environmental

We serve individual clients and also provide validation methodology, support and training for other businesses in the field.

We collaborate with clean-room designers and manufacturers on validation.

Our IQ OQ PQ brochures available as PDF downloads:

	IQ OQ PQ Overview
	Validation for Facilities & Processes
	IQ OQ PQ for Clean Rooms
	IQ OQ PQ for CE
	IQ OQ PQ for GC & GC-MS
	IQ OQ PQ for HPLC & LC-MS
	IQ OQ PQ for Temperature, Humidity, CO2 and Light Controlled Devices
	IQ OQ PQ and GLP

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