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.

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GxP Advisory and Validation compliance services

5 Key Points

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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.

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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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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.

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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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Case studies: a track record of excellence

See the results of so many who have used the eLeaP system

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