Process & Product Validation

Starting With Success In Mind:

With our comprehensive process validation procedures, our customers know that Harmac's medical device manufacturing processes have the right controls in place to produce products that are safe and meet user, technical and regulatory requirements. From the initial design stage and throughout the product life cycle, each process is scrutinized to ensure that the output will consistently meet production quality specifications.

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How We Help:

  • Using a Risk Analysis Approach

    • With increased focus on risk mitigation, Harmac uses Failure Mode Effect and Criticality Analysis (FMECA) to assist our customers in getting innovative and promising new products to market – and to patients – as quickly as possible, particularly in instances where there is an unmet need.
    • Harmac's knowledge of process validation as a key element to identifying and mitigating risks for medical devices ensures that products are not only effective, but also as safe as possible, fulfilling the needs of both regulators and patients.
  • Compliance

    • Harmac operates in full compliance with the following guidelines: FDA Quality System Regulation (21 CFR 820) and ISO 13485 (Medical Devices - Quality Management Systems QMS).
  • Comprehensive Validation Process

    • As part of validation master plans, Harmac employs the following framework to ensure variation is predictable but minimal, and that, ultimately, products will meet the needs of our most important end user – patients.

    Installation Qualification (IQ) - confidence that the primary equipment and ancillary systems are capable of performing the operations in question

    Operational Qualification (OQ) - the equipment and systems, as installed or modified, perform as intended throughout the anticipated operating ranges

    Performance Qualification (PQ) - the process is capable of producing products within specification when all process parameters are set at the nominal settings

    Process Performance Qualification (PPQ) - the process is capable of producing products within specification when all sources of variability are assessed

    Test Method Validation (TMV) – objective evidence establishes that the test method employed consistently and repeatedly distinguishes acceptable and unacceptable units

    Measurement System Analysis (MSA) - evaluates a test method, a measuring instrument and/or the entire measurement process to ensure data integrity for quality analysis