Electronic Document & Data Management

Life Cycle Management

The integration of Electronic Document and Data Management (EDDM) within a Regulatory Information Management System (RIMS) provides a structured, validated environment for the creation, review, approval, and archiving of regulatory records.

Effective document and data governance is a foundational requirement for maintaining regulatory compliance throughout the product lifecycle. The integration of Electronic Document and Data Management (EDDM) within a Regulatory Information Management System (RIMS) provides a structured, validated environment for the creation, review, approval, and archiving of regulatory records.

EDDM functionality within RIMS supports the end-to-end management of regulatory submissions, product registrations, and authority correspondence by centralizing all controlled documents and data assets. This enables organizations to ensure traceability, enforce version control, and uphold data integrity in alignment with applicable regulatory standards, including ICH, GxP, FDA 21 CFR Part 11, and EU Annex 11.

Through automated workflows, secure access controls, and comprehensive audit trails, EDDM in RIMS enhances compliance oversight, reduces regulatory risk, and ensures ongoing inspection readiness across jurisdictions.

Maintenance of Submission History and Product Lifecycle Data in Regulatory Information Management (RIM) Systems

Maintaining robust and accurate submission history and product lifecycle data is essential to achieving regulatory compliance in an increasingly complex and globalized life sciences environment. Regulatory Information Management (RIM) systems serve as foundational tools that enable life sciences organizations to manage global regulatory data efficiently, ensuring traceability, transparency, and alignment with evolving health authority expectations.

A well-configured RIM system acts as a central repository for managing the complete lifecycle of regulatory submissions and product registration data, supporting informed decision-making, timely compliance actions, and proactive health authority engagement.

Key Features of RIM Data Maintenance

Techsol’s Role in Regulatory Data Governance and RIM Maintenance

Techsol provides specialized services to support the implementation, configuration, and maintenance of RIM systems across the product lifecycle. Our regulatory and technical teams partner with organizations to establish and maintain a consistent, audit-ready “single source of truth” for all regulatory submissions and lifecycle events.

By ensuring that submission history, variations, renewals, and post-approval commitments are systematically tracked and updated, Techsol enables clients to meet global regulatory requirements and internal governance standards with confidence.

Our Services Include:

Our Expertise and Value Proposition

Regulatory and Technical Expertise: Proficiency in leading RIM platforms including Veeva Vault RIM, ArisGlobal, and proprietary systems, enabling rapid implementation and effective system utilization
Established Governance Frameworks: Deployment of structured data governance models to ensure standardization, auditability, and lifecycle continuity across the regulatory function
Integrated Cross-Functional Collaboration: Alignment of regulatory operations with quality, pharmacovigilance, and clinical data flows to support a harmonized and compliant regulatory environment
Scalable Global Service Delivery: Support for regional and enterprise-wide RIM initiatives through multilingual teams and scalable operating models that align with client geographies and timelines
Regulatory Inspection Preparedness: Ensuring that regulatory data is consistently accurate, complete, and accessible—supporting readiness for audits, inspections, and health authority queries at any time

Document Version Control, Archival, and Compliance with Regulatory Standards

In highly regulated industries such as pharmaceuticals, biotechnology, and medical devices, ensuring the integrity, traceability, and governance of regulatory information is not just a best practice—it’s a compliance mandate. Regulatory authorities worldwide, including the FDA, EMA, and other global agencies, require strict controls over the creation, review, approval, and retention of documentation throughout the product lifecycle.

At Techsol, we understand these challenges. Our cutting-edge Regulatory Information Management (RIM) solutions integrate seamless Document Version Control, Archival, and Compliance features designed to keep your organization audit-ready and fully aligned with global regulatory standards like FDA 21 CFR Part 11, EMA eCTD, and ICH guidelines.

With Techsol’s RIM system, regulatory teams gain complete control over document histories, ensure data integrity through precise version management, and maintain secure, accessible archives. This empowers your team to reduce compliance risks, accelerate regulatory submissions, and maintain readiness for inspections—supporting your mission to bring safe, effective products to market efficiently and confidently.

Partner with Techsol to transform your regulatory information management into a strategic advantage in today’s complex regulatory landscape.

Techsol’s Regulatory Information Management System (RIMS), integrated with advanced Electronic Document and Data Management (EDDM) capabilities, is purpose-built to meet these stringent expectations.

Key Services Include:

Version Control Management: Implementation of controlled version numbering, access permissions, and approval workflows to ensure that only authorized and validated versions are in use
Audit Trails and Change History: Detailed logging of document creation, edits, reviews, approvals, and distribution activities for full traceability during inspections and audits
Secure Document Archival: Long-term storage of regulatory documents in compliant, access-controlled repositories ensuring data integrity and disaster recovery readiness
Regulatory Compliance Alignment: Adherence to global regulations including FDA 21 CFR Part 11, EMA Annex 11, and other regional standards governing electronic records and signatures
Workflow Automation: Automated review and approval processes integrated with electronic document management systems (EDMS) to streamline compliance and reduce manual errors
Document Retention and Disposition: Policies and processes for document retention periods, archival, and secure disposal aligned with regulatory and corporate requirements
Reporting and Analytics: We set up dashboards and custom reports within Vault to monitor document statuses, outstanding actions, and compliance metrics in real-time
Training and Change Management: Our experts provide hands-on Veeva Vault training and change management support, ensuring your team maximizes the platform’s potential while maintaining compliance

Our Expertise and Value Proposition

Expertise in Regulatory Document Management Standards: Our regulatory specialists and quality experts understand complex compliance requirements and apply best practices tailored to your operational needs
Advanced Document Management Technologies: We utilize leading EDMS platforms (e.g., Veeva Vault) configured for seamless version control and compliance reporting
Comprehensive Audit Readiness: We ensure your documentation is fully traceable, with all versions, approvals, and revisions clearly documented to facilitate successful regulatory inspections
Customized Training and Support: We provide user training, SOP development, and ongoing support to empower your team to maintain compliant document control practices confidently
Risk Mitigation and Quality Assurance: By controlling document versions and archives, Techsol helps reduce regulatory risk, support quality assurance initiatives, and safeguard intellectual property