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Documentation Simplification
Batch Record Simplification
Batch Record Guidance and Good Documentation Practices
Guidance for Writing Procedures
Standard Operating Procedure (SOP) Simplification
SOP Training Workshops
EBR / MES
Migrating from Paper to Electronic (EBR/MES)
Short & Long-term Strategies
Compliance
Compliance Remediation
Data and Process Integrity
Process Mapping
Simplify and Improve Workflow
Contact Us
Careers
Home
About Us
Experience
Case Studies
Partners
Services
Documentation Simplification
Batch Record Simplification
Batch Record Guidance and Good Documentation Practices
Guidance for Writing Procedures
Standard Operating Procedure (SOP) Simplification
SOP Training Workshops
EBR / MES
Migrating from Paper to Electronic (EBR/MES)
Short & Long-term Strategies
Compliance
Compliance Remediation
Data and Process Integrity
Process Mapping
Simplify and Improve Workflow
Contact Us
Careers
Case Studies Index | Malcom Associates
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Case Studies Index
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Case Studies Index
Case Studies
Cell and Gene Therapy – Preparing for Increased Demand
Documentation Road Map for EBR Implementation
Documentation Rules and Reduction in Error Rates
Equipment Cleaning SOP Remediation
Establish Rules and Reduce Error Rates
Framework for Efficient 510(k) Process
GMP Enhancement Initiative
Improve Compliance with ISO 14971
Improve Data Integrity
Preparing for Increased Demand -100% Right-First-Time
Product Transfer and 87% Reduction in Error Rates
Remediation and Regulatory Closure
Sample Tracking and Worklflow Management Redesign
Remediation and Data Integrity