QMS & Med. Compliance
QMS and Medical Device Consulting
QMS & Medical Device Consulting
Tailored strategies to ensure compliance and operational excellence
eLeaP’s QMS Establishment Services offer comprehensive support for companies aiming to create and uphold a robust Quality Management System (QMS). We specialize in drafting Standard Operating Procedures (SOPs) for different departments, delivering personnel training, generating batch production records, conducting annual product reviews and trends analysis, initiating CAPA programs, and devising strategies for cross-contamination prevention, process validation, and cleaning protocols to ensure the highest standards of quality and compliance are met.
Details of our QMS & Medical Device Advisory Services
We focus on five pivotal elements to elevate quality and compliance, ensuring your operations meet regulatory standards effectively:
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SOPs for Key Departments
Crafting SOPs for various departments including QA, production, and more, ensuring comprehensive operational guidelines.
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SOP Personnel Training
Conducting detailed personnel training on SOPs to enhance compliance and operational efficiency.
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Batch Record Management
Developing batch production or master records for meticulous tracking and quality control.
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Product Trends Analysis
Developing batch production or master records for meticulous tracking and quality control.
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Safety & Validation Setup
Establishing robust CAPA programs alongside protocols for cross-contamination prevention, process validation, and cleaning to uphold the highest standards of product safety and efficacy.