Good Manufacturing practices (CGMP)
CGMP Consulting
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Preserving data integrity is a vital component in guaranteeing the manufacturing quality of your medical device. It’s an essential aspect of current good manufacturing practices (cGMP), and it’s imperative that employees possess the requisite experience and knowledge to accurately record and manage data, thereby mitigating any potential data integrity issues.
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In an era where data breaches are a prevalent concern for businesses in the life science sector, the importance of robust practices for data storage and release has escalated. Medical device companies, irrespective of their size and nature, need to have confidence in the integrity of their data. This is the reason why numerous businesses have sought the GMP quality compliance services of Regulatory Compliance Associates.
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With over 20 years of industry experience, we possess the know-how to comply with the standards set by global regulatory authorities. We provide the expertise necessary to ensure your business remains within cGMP guidelines and safeguards the integrity of your data. Our comprehensive suite of training and consulting services guarantees that your customers’ faith in your brand is justified.
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Quality Consulting Services
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The optimal approach to uphold robust business practices and prepare for an FDA audit is through comprehensive training and meticulous preparation. Educating employees and executives across your organization can enhance data storage practices and foster a deeper comprehension of the significance of appropriate storage for your business. Regulatory Compliance Services can assist in preserving quality compliance across all facets of your enterprise, spanning from design and manufacturing to packaging and distribution. The services we offer encompass:
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Good Documentation Practices (GDP), focusing on data recording methods, error correction techniques, and documentation of error reasons.
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Yearly adherence to Good Manufacturing Practice (GMP).
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Conducting thorough investigations.
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Implementation of Corrective Action and Preventive Action (CAPA) measures.
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Consulting
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Consultation on Current Good Manufacturing Practices (cGMP)
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Thorough Auditing Procedures
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Formulation of a Remediation Plan to Mitigate Identified Risks and Vulnerabilities
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Support in Implementing the Remediation Plan
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Should an audit occur, all data collected throughout the manufacturing process of your medical device—from its initial stages to its launch and all steps in between—will serve as a defense for the product’s application once it has been approved for patient use.
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Select Coastal Quality Consultants as your Quality Assurance Auditors.
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At Coastal Quality Consultants, we recognize the enduring effects a compliance crisis can impose on your enterprise. Whether you’re at the helm of a Fortune 100 company or a small business striving to navigate the complexities of cGMP maintenance, we seize every chance to assist your organization in adhering to FDA and worldwide regulations.
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