Quality System Implementation
All medical device-manufacturing companies in the US
need to follow good manufacturing practices (GMP). Current good
manufacturing practice (CGMP) requirements are set forth in this quality
system regulation (QSR) of the 21 Code of Federal Regulations (CFR) Part
820. The FDA is responsible for monitoring the QSR compliance of all U.S.
medical device companies.
Verotech’s Quality Team will provide valuable and
informed insight for developing and implementing their client’s
comprehensive quality plan. We
will also advise and assist in developing and maintaining quality management
systems and continuous improvement initiatives.
Quality System
Services Provided:
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GxP Training and Audits
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Quality Agreement Preparation
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Authoring Quality Manuals and Procedures (SOP)
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Preparing Work Instructions and Process Maps
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Device Master Records & Device History Records
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Design History Files (DHF)
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CAPA program development and implementation
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Remediating compliance Support (Warning Letters, Complete Response Letters and Consent Decrees)
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Risk Assessment
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Validation Approach
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Quality System Implementation
Our Team will provide valuable and informed insight for developing and implementing their client’s comprehensive quality plan.
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Medical Device
Successfully validating a process may reduce the dependence upon intensive in process and finished product testing. Our Engineers have been involved in development of various new design concepts for our medical device clients
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Pharmaceutical
Verotech Engineers have been involved in pharmaceutical manufacturing process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference.
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Risk Assessment
The US FDA, European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators recognize it as the "de facto" standard for risk management.