Quality Assurance_Ensuring documentation and system compliances

To ensure that our clients get the most compliant documents we have created a Quality Assurance department within the organization that offers an unbiased review of the technical files prepared by our in-house regulatory department before they are submitted to the regulatory authorities. The department also takes care of gap analysis of files prepared by manufacturers to significantly reduce the probability of non-compliance during external reviews.
Furthermore, the QA department is also responsible for handholding the client through the Quality Management System preparation, implementation, and training to cater to the requirements of various regulatory and quality standards like ISO 9001, ISO 13485, MDSAP, 21 CFR Part 820, etc. Our approach is not limited to preparing a standard set of documents but rather tailoring the documentation around the practices being followed by a manufacturer and helping them maintain a system that would increase transparency and traceability in their systems.
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