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Validation: an introduction to IQ , OQ and PQ .

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Validation: an introduction to IQ , OQ and PQ .

Validation: an introduction to IQ, OQ and PQ. This seminar teaches the basics of validation. It is designed for people who have no experience in validation. The participants will learn how to write practical protocols that are compliant yet flexible enough to allow for real-world conditions.

http://www.vcillc.com/training/Class.Outline-Validation.an.introduction.to.IQ.OQ.and.PQ.pdf

Date added: March 2, 2012 - Views: 307

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ABC LABORATORIES - Elsmar

EQP-ABC-04-001 Lunaire Environmental Chamber Ver. 4.0 IQ/OQ/PQ Protocol March 23, 2004 Page 1 of 42 ABC LABORATORIES Lunaire Environmental Chamber

http://elsmar.com/pdf_files/IQ_OQ_PQ_protocol_sample.pdf

Date added: April 27, 2012 - Views: 44

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FDA Guidance for Industry Update - Process Validation

The changing face of Validation; are IQ, OQ and PQ really dead and buried?really dead and buried? In November 2008, the FDA released a draft version of its long-awaited update to its Process Validation Guidance for Industry.

http://www.pharmout.net/downloads/white_paper_fda_process_validation_guidance_update.pdf

Date added: November 23, 2012 - Views: 101

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IQ/OQ/PQ - CfPA

IQ/OQ/PQ 10±11 March 2014 · Amsterdam, The Netherlands | Offering# 1403-203 The Center for Professional Advancement 2014 COURSE OUTLINE www.cfpa.com

http://www.cfpa.com/pdf/2014/1808,F,1403-203.pdf

Date added: October 25, 2013 - Views: 22

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Validation: an introduction to IQ, OQ and PQ.

Validation: an introduction to IQ, OQ and PQ. This seminar teaches the basics of validation. The participants will learn how to write practical protocols

http://www.vcillc.com/sites/vcillc.com/files/pdf/Class.Outline-Validation.an.introduction.to.IQ.OQ.and.PQ.pdf

Date added: January 10, 2014 - Views: 9

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REQUIREMENTS FOR COMPUTER SYSTEM REQUIREMENTS, VALIDATION ...

This procedure applies to all computer system validation plans, protocols (IQ, OQ, or PQ), protocol reports, and Validation Final Reports. 3. REFERENCE DOCUMENTS [Note to the purchaser of this document: The policy documents, procedures, and

http://www.complianceonline.com/images/supportpages/501056/sample_VAL004%20Req%20for%20val%20plans%20%20protocols%207%20Mar%2006.pdf

Date added: May 25, 2012 - Views: 48

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IQ/OQ/PQ

IQ/OQ/PQ 18±19 February 2013 · Amsterdam, The Netherlands Dr./Mr./Ms. Job Title Company/Organization Department/Mail Code Mailing Address Fax: ... • Prepare IQ/OQ/PQ Protocols and Verification Protocols • Perform execution of approved protocols

http://www.cfpa.com/PDF/2013/1808,C2-128,1302-402.pdf

Date added: May 27, 2013 - Views: 25

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IQ, OQ, PQ Qualification Seminar Presentation - Home - Mangan

IQ, OQ, PQ Qualification Seminar Presentation Derry, New Hampshire. April 2, ... “Our ability to successfully execute qualification protocols, ... and performance qualification practices, please visit: www.eastcoastvalidation.com

http://www.eastcoastvalidation.com/news/ECVS-PR-4-2-13.pdf

Date added: June 5, 2013 - Views: 18

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A WHO guide to good manufacturing practice (GMP) requirements

Each IQ, OQ, and PQ protocol provides the specific procedure to follow, information to be recorded, a set of acceptance criteria, ... examples of IQ, OQ, and PQ protocols. 11.1 System: heating, ventilation, air conditioning (HVAC) IQ, OQ, PQ. HVAC IQ.

http://whqlibdoc.who.int/hq/1997/WHO_VSQ_97.02.pdf

Date added: December 19, 2011 - Views: 241

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Thermo Scientific Validation Services for Laboratory Equipment

Improved Productivity Our factory-developed IQ, OQ, PQ protocols allow you to start the review process before the equipment arrives, increasing product uptime.

http://labequipmentparts.com/support/documents/BRSERVALID1010.pdf

Date added: October 26, 2012 - Views: 19

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Business Performance Document #: VAL015 ECO #: Associates ...

The purpose of this procedure is to provide guidance on what to test in IQ, OQ, and PQ protocols for computer systems. This procedure is a guidance document and is not binding. 2. SCOPE This document applies to computer systems using off-the-shelf, ...

http://www.complianceonline.com/images/supportpages/501091/sample_VAL015%20Guidance%20items%20for%20IQ%20OQ%20PQ%2023%20June%2006.pdf

Date added: April 23, 2012 - Views: 29

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MicroBio MB1 IQ/OQ/PQ - Cantium Scientific

MicroBio MB1 IQ/OQ/PQ Installation, Operational and Performance Qualification Protocol and Report for the MicroBio MB1 Bioaerosol Sampler Document No:

http://www.cantiumscientific.com/downloads/P0001W004.pdf

Date added: April 10, 2012 - Views: 15

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Pharmaceutical Cleanroom Commissioning, Certification, and ...

DQ, IQ, OQ, and PQ Pharmaceutical Cleanroom Commissioning, Certification, and Validation DQ, IQ, OQ, and PQ April 2005 Presented by ... Cleanroom Operation Protocols for Cleanroom Operations Executed in Parallel with During Commissioning – Testing, Balancing, Certification

http://www.gmpua.com/CleanRoom/Design/CleanroomQualification.pdf

Date added: December 18, 2011 - Views: 277

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Validation Protocols & On-Site Validation Services

initiate your Validation Master Plan and perform IQ, OQ and PQ (suitability of the test methodology) with ease. Validation Protocols consist of the following test sections: Validation Protocols & On-Site Validation Services Proven protocols and expertise to qualify Millipore products for use in ...

http://www.millipore.com/publications.nsf/a73664f9f981af8c852569b9005b4eee/fd6a5ba625070da085257810005ce909/$FILE/SDS00200000.pdf

Date added: November 2, 2012 - Views: 34

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EQUIPMENT QUALIFICATION PLAN (EQP) - Agilent Technologies

protocols, calculates results and produces the reports. Naturally it is fully validated and tested. ... Policy documents dictate the need for validation & qualification of GMP/GLP systems and usually mention the DQ/IQ/OQ/ PQ model.

http://www.chem.agilent.com/Library/service/Public/Review%20Document_Standard_EQP_GC.pdf

Date added: April 10, 2012 - Views: 23

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Process Validation 101 - DIGICOM Electronics

This plan identifies the three IQ, OQ and PQ protocols and includes the acceptance criteria that each of these must meet their respective acceptance criteria for the validation to be acceptable. The process validation report

http://www.digicom.org/Electronics-Manufacturing-Services-EMS-Process-Validation-101.pdf

Date added: October 26, 2012 - Views: 35

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Steril-Q - Consolidated Sterilizer Systems

Made in USA Steril-Q™ IQ/OQ/PQ Validation Services Steril-Q™ Validation and Documentation Services Steril-Q™ includes an array of documentation, tools and

http://www.consteril.com/wp-content/uploads/2013/08/SterilQ_techsheet.pdf

Date added: October 24, 2013 - Views: 5

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V1 Validation Protocols & On-Site Validation Services 29 03 11

Validation Protocols & On-Site Validation Services Rely on a comprehensive and ready ... Performance Qualification (PQ) ... Plan and perform IQ, OQ and PQ (suitability of the test methodology) with ease.

http://labface.com/suppliers/pdf/milliporevalidationpdf.pdf

Date added: May 6, 2013 - Views: 92

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RevereIT LLC

The IQ, OQ and PQ must be performed in order: the master validation plan should indicate how to deal with any deviations from these qualifications, and ... examples of IQ, OQ, and PQ protocols 11.1 System: heating, ventilation, air conditioning (HVAC) IQ, OQ, PQ .

http://revereit.com/pdf/RevereIT%20-%20Validation%20-%20An%20Introduction.pdf

Date added: November 13, 2012 - Views: 14

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ULT90 - Instrumart

IQ/OQ/PQ Validation Protocols Splash Proof Cryo-Temp Data Logger -86°C to +35°C Temperature Range 0.1°C Resolution and ±1.0°C Accuracy 1 Year Battery Life at -80°C User-Programmable Temperature Alarms with LED’s (OK, Warn, and Alarm)

http://www.instrumart.com/assets/ult90-Datasheet.pdf

Date added: May 6, 2013 - Views: 4

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TrackWise – Maintaining the Validated State

−Validation protocols −Risk assessment −Training content / material ... IQ . OQ . PQ - Verify ‘intended use’ and administration of system . ... TrackWise Operational Qualification Protocol 6.

http://www.tugportal.com/Portals/_default/UC11NA/5C%20-%20TrackWise-Maintaining%20a%20Validated%20State.pdf

Date added: November 19, 2013 - Views: 3

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EQUIPMENT QUALIFICATION PLAN (EQP) - Agilent Technologies

protocols, calculates results and produces the reports. Naturally it is fully validated and tested. ... PQ model. The precise procedures for IQ & OQ for each type of equipment are prescribed in an approved SOP, perhaps called SOP #123: ...

http://www.chem.agilent.com/Library/service/Public/Review%20Document_Standard_EQP_LC.pdf

Date added: March 7, 2012 - Views: 35

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Installation Qualification/Operational Qualification ...

Protocol Acceptance by Customer and List of Tests Performed Bio-Rad Laboratories recommends that the IQ/OQ protocols be performed in total when the

http://www.bio-rad.com/webroot/web/pdf/lsr/literature/10005250C.PDF

Date added: December 16, 2011 - Views: 130

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Complete and Efficient Process Validation - FINAL

• Validation Protocols and Reports ... −IQ/OQ/PQ reports for equipment −Validation of critical process utilities −EIRs– last three years – look for validation issues −Change Control procedures and policies. Preparing for Validation – Quality Agreements

http://www.bptc.com/sites/default/files/presentations/complete.pdf

Date added: October 14, 2012 - Views: 13

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Process Validation Principles - University of Wisconsin–Madison

IQ-OQ-PQ ¸ Learn a how to select ... •Write protocols to handle contingencies and avoid deviations. No prior knowledge or special background is required. Attend and Benefit Engineers, manufacturing and quality per-sonnel, supervisors, and managers who are

http://epdfiles.engr.wisc.edu/pdf_web_files/epd/J912.pdf

Date added: April 23, 2012 - Views: 18

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MicroBio MB2 IQ/OQ/PQ

MicroBio MB2 IQ/OQ/PQ Installation, Operational and Performance Qualification Protocol and Report for the MicroBio MB2 Bioaerosol Sampler Document No:

http://www.cantiumscientific.com/downloads/P0002W002.pdf

Date added: May 24, 2012 - Views: 7

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USP < 1058 > AIQ Risk-Based Instrument Qualification Guidelines

3 10 harmonized, uniform AIQ protocols 2 4 Simplified 4Q Model 6 11 ... • DQ / IQ / OQ / PQ Risk Management: Grouping Instruments into A / B / C categories Flexibility in determining what is done in OQ and PQ Major Areas of USP <1058> AIQ Analytical Instrument

http://labcompliancesolutions.com/wp-content/uploads/2011/09/USP-1058-AIQ-Risk-Based-Instrument-Qualification-Guidelines.pdf

Date added: February 29, 2012 - Views: 242

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Process Validation for Medical Devices - Ombu Enterprises

IQ, OQ, PQ • Write a validation protocol • Conduct the protocol and collect the data • Analyze the data • Improve the process, as warranted, based on the data and analysis • Prepare a report • Keep the documentation as a quality record.

http://www.ombuenterprises.com/LibraryPDFs/Process_Validation_for_Medical_Devices.pdf

Date added: August 18, 2011 - Views: 60

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Pharmaceutical Regulation Impact When a client was required ...

• Design Qualification (DQ)- Protocols and specifications outlining minimum requirements for unique configurations of system hardware, software and ancillary software tools. ... Microsoft Word - CS Pharma IQ-OQ-PQ development.doc Author:

http://www.courtsquaregroup.com/pdf/case_studies/CS%20Pharma%20IQ-OQ-PQ%20development.pdf

Date added: June 5, 2013 - Views: 6

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ContinuousCustomer Support - PerkinElmer

• Consistent IQ, OQ, PQ protocols designed to fit your laboratory needs • Integrated solutions designed to reduce compliance risk Expert Multi-Vendor Validation support and consultancy, working with you to improve compliance, reduce risk and save money.

http://shop.perkinelmer.com/Content/onesource/Multi-vendor%20Validation%20Brochure.pdf

Date added: May 11, 2012 - Views: 10

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Validation and Qualification - Infitrak

documenting the procedures and protocols that demonstrate your equipment and processes operate within acceptable parameters. Validation and ... • IQ/OQ/PQ results and findings • Calibration parameters for any equipment used in the qualification testing

http://www.infitrak.com/wp-content/uploads/2012/05/Validation_and_Qualification1.pdf

Date added: March 31, 2014 - Views: 1

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Reasons, Regulations, and Rules: A Guide to the Validation ...

vidual definitions of IQ, OQ, and PQ, may be included. Com-pany policies, regulatory references, and published guidelines used in this selection process should be addressed. ... Protocols,” which can be used to gauge the man-hour require-

http://systemworksit.com/wdynamics/site/client_data/55/filedrop/uploads/01MJ-Saxton.pdf

Date added: August 13, 2013 - Views: 2

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Microplate Reader Validation and Compliance datasheet rev B

protocols are supplied with SoftMax Pro Software that are optimized for popular applications and kits for faster starts right out of the box. SpecTramaX microplaTe reader validaTion and compliance ... IQ/OQ/PQ Guidelines Software Validation. Title:

http://www.moleculardevices.com/documents/general-documents/mkt-collateral/microplate-qaqc-collateral/SpectraMax%20Validation%20Products%20datasheet%20rev%20A%20LR.pdf

Date added: October 26, 2012 - Views: 6

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Product/Process Validation (PHSC 338) - Campbell University

(VPM), validation protocols (DQ, IQ, OQ, PQ), validation summary report (VSR). Basics of a Validation Master Plan (VMP) Validation Master Plan Assignment 13 Feb George Waterhouse Good Documentation Practices Areas of Validation:

http://web.campbell.edu/faculty/fetterman/PHSC%20338/Process%20and%20Product%20Validation%20Schedule%20Spring%202004.pdf

Date added: March 11, 2013 - Views: 16

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Product/Process Validation (PHSC 338) - Campbell University

IQ/OQ and PQ Protocols Validation Projects: Overview of IQ/OQ and PQ; Discuss Content of IQ/OQ and PQ Protocols (continued) Prepare for Validation Project Execution 4 Apr Through 7 Apr Validation Project: Execute IQ/OQ and/or PQ Protocol

http://web.campbell.edu/faculty/fetterman/PHSC%20338/Process%20and%20Product%20Validation%20Course%20Schedule%20Spring%202005.pdf

Date added: May 6, 2013 - Views: 12

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FDA Validation Protocols and Services for QAD

The Installation Qualification (IQ) Protocols, the Operational Qualification (OQ) Protocols and the Performance Qualification (PQ) Protocols will provide documented verification that all key aspects of the software were installed, operate, ...

http://www.strategic.com/products/download/qad-fda-validation-protocols-and-services/

Date added: May 6, 2013 - Views: 6

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V VAALLIIDDAATTIIOONN GGUUIIDDEE - PackworldUSA

Process validation is considered to be a total process that includes written protocols, ... The validation system employs IQ, OQ and PQ as described above and combines these with process trials at preset operating settings. Replicates are undertaken and data

http://packworldusa.com/pdf/Packworld_Validation_Guide.pdf

Date added: April 17, 2012 - Views: 1

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Ultra Low Freezer Temperature Validation System

Software and IQ/OQ/PQ validation protocols. For larger freezers, loggers can be plotted in one graph to show variances in different parts of the freezer. Finally, as failure to monitor external freezer temperatures may invalidate

http://www.omega.com/DAS/pdf/OM-CP-ULT90.pdf

Date added: February 28, 2012 - Views: 25

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Process Validation of Solid Oral Dosage Forms, Part I General ...

Approves protocols and reports. ... Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Protocol Approval PQ Protocol Execution Data Analysis Validation Report and Conclusions Approve Conclusions Operator Training

http://www.ikev.org/haber/bozzonejune1.pdf

Date added: December 21, 2011 - Views: 261

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PROJECT AND VALIDATION SERVICES - Barry-Wehmiller Companies ...

Barry-Wehmiller Design Groupcan assist you with your complete validation needs. From specifications and master plans to FAT and IQ/OQ protocols, process validation,

http://www.barry-wehmiller.com/literature/BarryWehmillerDe/EngineeringConsu/validlr_728.pdf

Date added: October 25, 2013 - Views: 3

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COMMISSIONING - Maetrics

Developed and executed equipment qualification protocols (IQ, OQ, PQ), SOPs, and final reports for various process equipment including legacy equipment following recommissioning. Proposed and implemented modifications to procedures and equipment, in compliance with quality system

http://www.maetrics.com/documents/Case%20Studies/Commissioning_Case_Study.pdf

Date added: April 23, 2013 - Views: 10

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NEW! Alltech 3300 ELSD

Full IQ/OQ/PQ protocols included with each ELSD The 3300 ELSD is easy to integrate into a qualified HPLC system. It is thoroughly tested before shipment and calibration and performance documents are included with each instrument.

http://www.bioszeparacio.hu/_user/downloads/Alltech%20keszulekek/M147_3300ELSDlr.pdf

Date added: October 26, 2012 - Views: 5

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Product Specifications UV Validator Qualification ...

with direct and specific protocols allows a complete qualification of the instrument to ... IQ/OQ When purchased with both the UV ... (PQ) tests and documents that the system is adequate for specific tasks.

http://www.thermo.com/eThermo/CMA/PDFs/Product/productPDF_51149.pdf

Date added: October 13, 2012 - Views: 7

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VALIDATION VMP - İKEV

PROTOCOLS TESTS VALIDATION REPORTS VALIDATION Validation is a documented program that provides high ... CDQ IQ OQ PQ Process Cleaning Areas X Cleaning Equipments X Cleaning Machine Parts X Cleaning Garments X Filling Operation X Vial Washing X Plugging X

http://www.ikev.org/haber/val-mas-pl.pdf

Date added: May 16, 2012 - Views: 15

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A Comparison of the FDA’s Draft Process Validation Guidance ...

IQ/OQ/PQ per se. The EU GMPs prescribe content of IQ, OQ, and PQ with IQ having the most prescriptive detail. The FDA ... • These checklists that are labeled IQ/OQ protocols also could be used as the final verification report and the approval .

http://www.commissioningagents.com/clientuploads/directory/Documents/09mj-chew.pdf

Date added: October 7, 2011 - Views: 234

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DISSOLUTION TEST SYSTEM VALIDATION LOGBOOK

I agree that the IQ, the OQ and the PQ procedures in this document, assembled by DISTEK, München ... Attach protocols. LEFT BLANK. Version 20020416 REV 4 Printing Date: 12 May 2005 Page 13 of 35 DISTEK Dissolution Test System Validation Logbook Unit SN:

http://www.diessechem.com/download.php?file=1296231549-IQOQDIss_Copy.pdf

Date added: June 9, 2013 - Views: 9

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INSPECTION REMEDIATION - Maetrics

Developed and executed qualifications (IQ/OQ/PQ) for new equipment and applications Supported compliant, reliable data capture during execution of test protocols by developing electronic data systems and testing documentation (canned data sheets) for all: Raw materials

http://www.maetrics.com/documents/Case%20Studies/Insp_Rem_Case_Study.pdf

Date added: May 6, 2013 - Views: 4

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VAL-005 Validation-Concept and Procedure - Gmpsop

All DQ, IQ, OQ and PQ Protocols shall define the acceptance criteria with qualification procedures, be reviewed and approved by the persons identified in the Validation Plan prior to execution. All checks and testing must be carried out using measuring instruments that are

http://www.gmpsop.com/sample/VAL-005_Validation-Concept_and_Procedure_sample.pdf

Date added: November 2, 2012 - Views: 9

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Clean Room – HVAC GMP & ISO 14644 Validation Services

INSTALLATION QUALIFICATION Installation Qualification provides documented evidence that the Clean Room premises, supporting utilities and the equipment have been built and installed in compliance with their design specification and in accordance with EU GMP & ISO

http://www.stefatos.gr/client_files/Validation_Leaflet.pdf

Date added: December 30, 2011 - Views: 94

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SERVICE AND QUALITY - Caron Products

The validation services are performed according to IQ, OQ and PQ protocols. Caron’s validation services satisfy FDA guidelines for qualification verification of equipment. Full on-site and factory calibration services are offered.

http://caronproducts.com/lib/sitefiles/pdf/literature/lit_ServiceQuality.pdf

Date added: February 1, 2013 - Views: 2