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Metrology Solutions

Metrology Solutions. A Commitment to Quality. The standards for quality and integrity in the pharmaceutical industry are high. A sound metrology program is an important part of meeting this quality commitment.

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Metrology Solutions

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  1. Metrology Solutions

  2. A Commitment to Quality The standards for quality and integrity in the pharmaceutical industry are high. A sound metrology program is an important part of meeting this quality commitment.

  3. “ Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated and/or standardized.” 21CFR58.63(a):

  4. A complete metrology program. Experienced metrology and quality technicians. Laboratory design and standards assessment. Compliance to relevant industry standards. Expert technical writing. Uncertainty budgeting and Statistical Process Control.

  5. Military training Staff Average over 20 years metrology experience. Familiar with all major manufacturers’ hardware and software. Proficient in calibration, maintenance, and repair.

  6. Laboratory Design Efficient workspace configuration Critical environmental factors Technician safety considerations

  7. Standards Assessment Cost effective? Adequate for future as well as present needs? Supportable?

  8. Compliance to Industry Standards Designation: E 691 – 99 An American National Standard Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method 1 This standard is issued under the fixed designation E 691; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in NCSL ISO CFR OSHA ANSI GLP ASTM AAMI GMP NIST ASME

  9. Technical Writing  Standard Operating Procedures  Calibration procedures  Validation protocols  Quality manuals

  10. Uncertainty Budgeting Repeatability and Reproducibility testing Complete measurement system uncertainty analysis and reporting IAW NIST 1297 Proficiency testing IAW ISO/IEC F17025

  11. Audits Internal or external, technical or procedural, FDA, ISO, or client - we know what is necessary; will help you prepare, and stand by our work at audit time.

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