GxP, Validation & Advisory
Comprehensive GxP Compliance & Validation Solutions
GxP Compliance Made Easy
At eLeaP, we specialize in guiding organizations to achieve and maintain GxP compliance, crucial for pharmaceutical and biotech industries. Our services span from detailed audits and gap analysis to developing bespoke GxP implementation strategies. Whether you’re a startup navigating initial compliance challenges or an established entity aiming to enhance product quality and safety, our expert team is equipped to support your journey towards regulatory adherence and operational excellence.
5 Key Points
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System-Based GxP Audits
Conducting thorough facility GxP audits to identify gaps and provide tailored recommendations for enhancements across various areas such as facility design, utilities, equipment, and systems.
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Audit Preparation & Support
Offering expert guidance and on-site support to prepare for and navigate through regulatory audits, enhancing in-house expertise.
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Facility Design Compliance Reviews
Evaluating facility designs against global standards (USFDA, EU, TGA, etc.) to ensure GxP compliance.
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Facility Risk Assessment
Performing risk assessments based on OEL/OEB categories to identify and mitigate potential hazards.
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Vendor GxP Audits:
Assessing vendors to ensure their operations and supplies meet GxP standards, ensuring supply chain integrity.
Validation Services
Enhancing compliance through system and software validation
21 CFR Part 11 | Annex 11 Compliance Auditing, Gap Analysis and Recommendation Report
Lab Instrument Software Validation
BMS | EMS | LIMS | SAP | ERP | MES Validation
Cloud and IT System Validation Support
Excel Sheet Validation
Backup and Recovery Plans
Configuration Management
Supplier Audit Assistance
Validation Documentation Package
Development of Computer System Validation Master Plan (CS-VMP)
Development of Initial Risk Assessment (IRA)
Development of Functional Risk Assessment (FRA)
Development of Installation Qualification (including screen shots)
Development of Operational Qualification (including screen shots)
Development of Performance Qualification (including screen shots)
Development of Validation Traceability Matrix
Development of 21 CFR Part 11 Assessment Checklist (ERES)
Development of Validation Summary Report (VSR)
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.
GxP Training
Training programs designed to empower your team to meet rigorous compliance standards
Organizations benefit from reduced compliance risks, significant time and cost savings through automation, enhanced data security, and personalized learning paths and progress insights, ultimately ensuring regulatory adherence without compromising on the quality of learning experiences.
Experience a transformative shift in the life sciences landscape with eLeaP’s learning solutions system, where upskilling and compliance meets innovation and growth knows no bounds.
Why Choose eLeaP?
Understand the compelling reasons and unique advantages for selecting eLeaP as your learning solution.
We know you have choices when it comes to learning management systems or people success platforms. Here’s why hundreds of companies have selected eLeaP. Here’s a hint, it is because of the value they derive each and every day from the system and service.
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Brand
For over 19 years, we’ve been sound financial stewards of our brand, plowing back resources into our platforms so that our customers can continue to benefit from our stability.
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Innovation
eLeaP uses a simple, minimalist but sophisticated philosophy which does not sacrifice innovation or breath for complexity and confusion.
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Trust/Reliability
We ensure that the platform is tested and validated in our live development instance before integration to our production services.
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Platform
Having one platform for managing online, in-person, instructor-led, e-commerce and extended enterprise learning and training is simply awesome.
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Extended Services
We know that many of you come for the learning management system but end up staying for the extensive services we offer.
Case studies: a track record of excellence
See the results of so many who have used the eLeaP system
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Bionical Solutions
Founded in 2001, Bionical Solutions is a pharmaceutical manufacturing company headquartered in Willington, Derbyshire, United Kingdom. The company provides clinical, commercial, and digital services to life sciences companies in the...
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Biorasi, LLC.
Headquartered in Florida, United States, with office-based teams around the globe, Biorasi is a global, award-winning and full-service contract research organization (CRO) that delivers the speed and agility that today’s...
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Natus Medical Incorporated
Founded in 1989, Natus Medical (Natus) is a medical equipment manufacturer based in the US. The company offers medical equipment, software, supplies, and services for diagnosing, monitoring, and treating impairments...
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DealerStrong
Continuing Education
DealerStrong is a national retail automotive training and consulting company that works with clients to maximize their efforts and profits in the areas of Special Finance, Accounting, HR and BDC....