Healthcare & Drug Safety Documentation

 At Scriptorium Lab Services FZCO, we specialise in turning complex healthcare data and pharmacovigilance processes into clear, compliant, and actionable documentation.
Our writers bring decades of proven expertise supporting global healthcare technology and drug safety systems, having contributed to leading organisations, such as Oracle Health Sciences and Recovery Centers of America.

Every piece of documentation we create — from a regulatory SOP to an online help system — is engineered to uphold the highest standards of accuracy, compliance, and patient safety.

Our team’s portfolio includes hands-on documentation leadership across Oracle Health Sciences’ flagship products — Argus Safety, Empirica Signal and Topic, Empirica Study, and Clinical One — globally recognised for drug safety monitoring, signal detection, and clinical data management.

We:

• Revamped legacy documentation suites to Oracle’s unified content architecture and style standards.
• Remodelled online help systems and modernised information delivery for user efficiency.
• Adopted Agile documentation methods, producing deliverables for one major and three minor product releases.
• Authored and published Release Notes and Known Issues for over 12 patch releases on My Oracle Support.
• Delivered and maintained installation and data release guides for AERS, VAERS, Vigibase, and MedDRA — updated monthly, quarterly, and annually.
• Coordinated across global teams in the US (Bedford), Romania (Bucharest), and India (Noida & Bangalore) to manage review cycles and publication timelines.

In addition to documentation, we built short videos and eLearning modules for Oracle’s Safety, Clinical, and Healthcare portfolios, delivering impactful training content for global audiences.

• Developed nine English and seven Japanese training titles.
• Produced 10+ short training videos for product walkthroughs and feature tutorials. 
• Collaborated with translation vendors, SMEs, and global stakeholders to ensure accuracy and cultural alignment.
• Published courses to Learning Management Systems (LMS), assigned learning paths, and conducted Instructor-Led Training (ILT) sessions.
• Addressed end-user feedback and customer queries through structured content improvement cycles.
• Worked closely with UK, India, and Romania teams, resolving process and technical issues across multiple training projects. 

At Recovery Centers of America, our documentation extended into the operational and IT ecosystem — building policies, procedures, runbooks, and telephony workflows aligned with HIPAA and NIST compliance frameworks.

 Regulatory & Product Documentation

• Product documentation suites: User, Admin, and Installation Guides
• Structured authoring (DARB Authorkit) architecture 
• Release Notes, Known Issues, and Patch Documentation
• Data Release and Upgrade Instructions for AERS, VAERS, Vigibase, MedDRA
• Validation and Configuration Documentation

Compliance & Operational Documents

• HIPAA-aligned Policies and Standard Operating Procedures 
• Clinical Runbooks and Process Flow Diagrams
• Quality Management & Audit-Readiness Documents
• Controlled Document Cataloging and Version Governance

Training & eLearning Materials

• Product-based eLearning modules and short training videos
• Multilingual course content (English and Japanese titles)
• Instructor-Led Training (ILT) packages and user onboarding kits
• Collaboration with translation and localization teams
• LMS publishing, content tracking, and analytics dashboards

• Proven Domain Expertise
• Regulatory Alignment
• AI-Augmented Precision
• Global Collaboration
• Comprehensive Delivery Model