Pharmaceuticals - , ,
Electronic Data Quality and Compliance Associates is a dynamic solution provider that focuses on developing and successfully implementing optimized processes that support the creation, storage, transmission and transformation of regulated electronic data in the Pharmaceutical and Medical Device industries. EDQ&C Associates provides solutions for small to large enterprise organizations that see the value of enhanced data integrity, dramatically increased efficiency, security control, user satisfaction, reliability, disaster prevention/recovery, collaboration, and process optimization.Our clients quickly realize a significant return on investment (ROI) once our tools, techniques and methods have been implemented. EDQ&C Associates understands that all companies have a unique way of operating. EDQ&C Associates will leverage that uniqueness and provide a broad range of electronic data quality and compliance solutions that will exceed financial, business, and regulatory expectations while providing tremendous value to your organization.EDQ&C Associates understands how to apply modern quality and compliance tools, processes and techniques to solve common data integrity, validation, and regulatory challenges associated with electronic data, systems, and services for companies in the pharmaceutical and medical device industries.Whether you need a data integrity assessment, a single training class, or a comprehensive training program; a single SOP developed or an extensive QMS overhaul; a single validation or test plan written or QA oversight for a major validation project; EDQ&C Associates has the knowledge and experience to achieve success, enhance quality, and ensure compliance.Services include: • Data Integrity Assessments, Audits and Remediation• Quality Audits• Computer System Validation• Process Optimization• SDLC Methodologies• 21 CFR Part 11/Annex 11 Assessments, Audits and Remediation• Global Regulatory Compliance• Inspection Readiness Reviews• Requirements Gathering/ Analysis• Compliant Agile Processes• Risk Assessment/Mitigation• Information Security Planning• Quality and Regulatory Training
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