Electronic Document and Records Management System (EDRMS)

An Electronic Document and Records Management System (EDRMS) is an enterprise software that manages the complete lifecycle of documents and records. EDRMS supports the creation, storage, retrieval, distribution, and long-term preservation of information across the organization.

The core purpose of an EDRMS is to centralize and secure information handling. EDRMS helps organizations ensure traceability, version control, retention management, and regulatory compliance throughout the entire lifecycle of documents and records.

By replacing paper-based document and record management systems, an EDRMS improves collaboration and enforces standardized workflows. EDRMS maintains audit trails to ensure that documents and finalized records remain accurate and compliant with relevant requirements.

The system plays a critical role in regulated industries such as life sciences, healthcare, finance, legal services, and government, where compliance with requirements like FDA 21 CFR Part 11, EU GMP Annex 11, ISO 13485, HIPAA, and GDPR is mandatory.

Key capabilities of an EDRMS include centralized storage, version control, retention schedules, and audit trails. Other functions are electronic signatures, role-based access control, workflow automation, advanced search, and legal holds.

EDRMS can be deployed in the cloud, on-premises, or as a hybrid model. The right choice depends on organizational needs, infrastructure, and regulatory requirements.

An EDRMS boosts efficiency by automating tasks, improving access to information, and reducing paper reliance. EDRMS also strengthens compliance and security, lowers costs, enhances collaboration, and supports business continuity.

In many cases, an EDRMS functions as part of a broader electronic Quality Management System (eQMS). An EDRMS secures and organizes documents and records. An eQMS extends this functionality to quality processes, including CAPA, training, audits, supplier quality, and risk management.

SimplerQMS is a fully validated, cloud-based eQMS purpose-built for life sciences, offering robust electronic documents and record management alongside integrated quality processes. By unifying documentation with broader QMS processes, it streamlines operations, ensures full traceability, and supports compliance with requirements.

What Is an Electronic Document and Records Management System (EDRMS)?

An Electronic Document and Records Management System (EDRMS) is enterprise software designed to manage the full lifecycle of both documents and records. EDRMS combines document management capabilities with records management functions. The system ensures that organizations can work efficiently with active documents while preserving official records for compliance and accountability.

An EDRMS manages documents by supporting creation, editing, collaboration, version control, and secure storage. EDRMS manages records by enforcing classification schemes, retention schedules, legal holds, and secure archival or disposal. This dual capability ensures that information remains accessible and editable while active as a document and is securely preserved once finalized as a record.

Unlike basic document storage systems, which only store and organize files, an EDRMS provides advanced features such as audit trails, compliance monitoring, retention policies, electronic signatures, and secure record disposition. These features ensure information integrity, authenticity, and compliance with industry requirements.

The main components of an EDRMS include document management for storage and collaboration, records management for retention and secure disposal, security and access controls to protect sensitive information, audit trails to ensure compliance, and workflow automation to streamline review and approval processes.

Why Do Organizations Need an EDRMS?

Organizations need an EDRMS to manage the full lifecycle of documents and records in a single, secure platform. By automating capture, classification, and retention, an EDRMS streamlines workflows, supports compliance, and reduces risks tied to manual document handling. EDRMS increases efficiency by reducing reliance on paper-based systems and automating document routing and approval workflows, while version control and shared access enhance collaboration across teams.

At the same time, compliance is strengthened through retention schedules, audit trails, and regulatory alignment. An EDRMS also protects information with role-based access, encryption, and secure archiving, while lowering costs linked to storage, retrieval, and duplication of records.

Paper-based and manual document handling creates multiple challenges. These include slow retrieval times, risk of loss or misfiling, lack of version control, high storage costs, and limited ability to enforce compliance or retention policies. Manual systems also make collaboration harder and increase the chance of human error.

The absence of an EDRMS introduces significant risks. Organizations may face regulatory non-compliance, audit failures, data breaches, loss of critical records, inefficiencies, and reputational harm. Without a formal system, demonstrating accountability becomes difficult, especially in highly regulated sectors.

EDRMS adoption is widespread across industries such as government, life sciences, healthcare, finance, and legal services.

The purpose of using an EDRMS in business, government, and regulated industries is to ensure efficiency, accountability, and compliance. In business, it improves collaboration, reduces risks, and protects intellectual property. In government, it ensures transparency, accountability, and public record preservation. In regulated industries such as healthcare, life sciences, or finance, an EDRMS enforces strict compliance with legal and regulatory requirements while maintaining the security and integrity of critical documents and records.

What Are the Main Features of an EDRMS?

The main features of an Electronic Document and Records Management System are listed below.

• Document Capture and Import: Enables organizations to digitize paper records and import electronic files from multiple sources into a centralized system.
• Storage and Organization: Provides a secure repository with structured folders and metadata for efficient document and record organization.
• Version Control: Maintains accurate version history, ensuring users always access the most current approved file.
• Access Control and Security: Applies role-based permissions, encryption, and authentication to safeguard sensitive information.
• Search and Retrieval: Offers powerful indexing and metadata tagging for quick and accurate access to documents and records.
• Collaboration Tools: Supports real-time sharing, review, and approval workflows across teams and departments.
• Records Management: Enforces retention schedules, archival rules, and disposal policies to ensure compliance with legal and regulatory requirements.
• Workflow and Process Automation: Automates routine tasks such as approvals, routing, and notifications, increasing efficiency and reducing errors.
• Compliance and Legal Hold: Provides audit trails, e-signatures, and legal hold functions to meet industry and regulatory standards.
• Reporting and Analytics: Generates insights on system usage, workflow performance, and quality metrics for continuous improvement.
• Integration Capabilities: Provides the ability to integrate with other business systems such as ERP, CRM, QMS, and productivity tools to streamline operations.

Document Capture and Import

Document capture and import in an EDRMS refers to the process of collecting paper and electronic files into a single, centralized repository. This feature is designed to ensure that all documents and records, regardless of origin, are consistently digitized, indexed, and managed under strict control.

Organizations benefit from faster access to information, reduced risks of document loss, improved compliance, and stronger disaster recovery readiness.

For example, files may be scanned, uploaded, or automatically imported from sources such as email or enterprise systems, with metadata and classification applied at the point of entry.

Storage and Organization

Storage and organization in an EDRMS provide a secure, centralized repository where all electronic documents and records are structured, categorized, and retained throughout their lifecycle. Storage and organization ensure that files remain easy to locate, fully traceable for compliance purposes, and consistently organized according to company policies.

The primary advantages of storage and organization include faster document retrieval, elimination of duplicates, reduced risk of misplacement, and enhanced operational efficiency.

In practice, metadata, indexing, and folder hierarchies are applied, and users can retrieve documents instantly using advanced search or filtering features.

Version Control

Version control tracks every change made to a document or record while preserving a complete revision history. The primary role of version control is to guarantee that employees always use the latest approved version while preventing outdated or unapproved documents from circulating.

For organizations, version control reduces errors, strengthens regulatory compliance, and creates clearer accountability across teams.

A typical scenario occurs when a document is updated or approved, the EDRMS automatically generates a new version number, archives the previous version, and ensures only the latest version is active.

Access Control and Security

Access control and security are measures within an EDRMS that define who can view, edit, approve, or archive specific documents and records. These measures help safeguard sensitive information, enforce compliance, and ensure that only authorized personnel interact with critical files.

Key advantages include enhanced information protection, reduced risk of unauthorized changes, improved accountability, and adherence to applicable compliance requirements.

In practice, administrators assign role-based permissions. For example, a manager may be granted approval rights, while other staff members have view-only access. Every action is recorded in the audit trail to ensure accountability and compliance.

Search and Retrieval

Search and retrieval tools enable users to locate documents and records quickly using keywords, filters, or metadata tags. The purpose is to provide fast, accurate access without the inefficiency of manual searching.

Key benefits include time savings, increased productivity, reduced risk of errors, and improved audit readiness by ensuring critical files remain easily accessible.

Documents are typically indexed by fields such as title, author, type, or date, and full-text search capabilities allow users to instantly retrieve relevant files.

Collaboration Tools

Collaboration tools in EDRMS allow multiple users to review, comment, and contribute to documents while maintaining control and compliance. Collaboration tools streamline teamwork and approval processes by enabling real-time feedback and shared editing in a secure environment.

The value of collaboration tools includes faster reviews, reduced communication gaps, less duplicated effort, and stronger decision-making.

As an example, users can co-author documents, add comments, or suggest edits, with all contributions tracked in the system to ensure transparency and compliance.

Records Management

Records management ensures finalized records are stored, protected, and retained according to defined schedules and regulatory requirements. The records management process helps maintain the integrity, authenticity, and long-term accessibility of information, and includes the secure disposal of records once their retention period has expired.

Key benefits include reduced compliance risks, consistent retention adherence, and stronger accountability.

In many cases, an EDRMS enforces retention schedules automatically, prevents unauthorized changes to finalized records, and ensures critical records remain accessible for audits, investigations, or legal reviews.

Workflow and Process Automation

Workflow and process automation route documents and records through predefined review, approval, and distribution steps. The goal of workflow and process automation is to minimize manual handling, enforce consistency, and ensure tasks are completed on time.

Workflow and process automation deliver faster processing, fewer errors, standardized approvals, and greater accountability across teams.

For instance, when a new policy is uploaded, the system can automatically assign it for review, route it to approvers, and notify staff for training, with every action tracked in the system.

Compliance and Legal Hold

Compliance and legal hold functions safeguard documents and records that may be required for regulatory reviews, litigation, or audits. Their purpose is to ensure that no record under hold is altered or deleted until the requirement is lifted.

Benefits of compliance and legal hold include reduced legal risks, stronger audit readiness, and greater organizational accountability.

When applied, a legal hold locks the affected records from deletion while still allowing authorized users to search and review them until the case or audit is closed.

Reporting and Analytics

Reporting and analytics features provide insight into how documents and records are being created, managed, and used across the organization. The purpose is to monitor efficiency, identify bottlenecks, and ensure compliance with policies and other requirements.

Advantages include improved decision-making, better visibility of processes, and stronger performance tracking.

Managers often rely on dashboards or scheduled reports to review pending approvals, storage utilization, user activity, and compliance or quality metrics.

Integration Capabilities

Integration capabilities allow an EDRMS to connect with other enterprise systems such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Product Lifecycle Management (PLM), Quality Management System (QMS), or productivity software. The purpose is to eliminate data silos, reduce duplicate entries, and create seamless workflows across departments.

Improved data consistency, higher efficiency, and greater alignment between business processes are some of the benefits of effective integration.

For example, an EDRMS may integrate with Microsoft Office for in-system editing, ERP systems for linking records to production data, or CRM tools for attaching controlled documents to customer accounts, ensuring information flows smoothly across platforms. Integrating with QMS software centralizes compliance documentation, such as audit records and CAPAs, keeping information accessible, traceable, and up to date.

What Are the Types of Electronic Document and Record Management Systems?

The main types of EDRMS are described below.

• Cloud-Based EDRMS: A cloud-based EDRMS is hosted on secure remote servers and accessed through the internet. Cloud-based EDRMS offers flexibility, scalability, remote access, and lower upfront costs. It is ideal for organizations that want simple system updates, mobile access, and reduced IT maintenance.
• On-Premises EDRMS: An on-premises EDRMS is installed and operated on an organization’s internal servers. This deployment provides complete control over data security, customization, and regulatory compliance. On-premises EDRMS is best suited for industries with strict data sovereignty requirements but that demand higher investment in infrastructure and IT support.
• Hybrid EDRMS: A hybrid EDRMS combines the advantages of cloud and on-premises solutions. Sensitive or mission-critical records can remain securely stored on-site, while cloud features provide scalability, collaboration, and cost efficiency for less critical workflows.

What Are the Common Use Cases of EDRMS Across Different Industries?

Below are the most frequent applications of EDRMS across industries.

• Life Sciences: The life sciences industry uses EDRMS to manage controlled documents such as SOPs, training records, and batch documentation. EDRMS supports compliance with FDA, ISO 13485, and EU GMP requirements while ensuring traceability and audit readiness.
• Healthcare: Healthcare organizations apply EDRMS to secure patient records, policies, and clinical documentation. The technology supports HIPAA and GDPR compliance, protects sensitive information, and improves efficiency in patient care delivery.
• Manufacturing: Manufacturing companies rely on EDRMS to manage production records, quality documentation, and process instructions. EDRMS enhances traceability, reduces reliance on paper, and ensures alignment with regulatory and industry-specific requirements.
• Construction and Engineering: In construction and engineering, EDRMS manages project files, blueprints, contracts, and compliance records. EDRMS improves collaboration across teams, ensures version control, and reduces project risks tied to outdated or lost documents.
• Legal: Legal firms and departments use EDRMS to store case files, contracts, and regulatory documents. The platform strengthens confidentiality, ensures secure client data handling, and speeds up retrieval for audits and litigation.
• Financial: Financial institutions adopt EDRMS to manage compliance records, audit files, and client agreements. The system helps meet regulations such as SOX, GDPR, and ISO 15489 while reducing operational risks and maintaining data security.
• Government: Government agencies depend on EDRMS to manage public records, policies, and administrative documentation. EDRMS ensures transparency, accountability, and long-term preservation of information while supporting e-governance initiatives.

What Are the Benefits of Implementing an EDRMS?

The key benefits of an EDRMS are listed below.

• Increase Efficiency and Productivity: EDRMS reduces manual tasks with automation, metadata tagging, and advanced search. Organizations achieve faster decision-making and greater productivity.
• Ensure Regulatory Compliance: Using EDRMS enforces version control, electronic signatures, and audit trails. EDRMS supports compliance with FDA, ISO, GDPR, HIPAA, and other global standards.
• Enhance Security: EDRMS protects sensitive data with role-based access, encryption, and tamper-proof records. Information remains secure while minimizing risks of breaches.
• Reduce Costs: The system of EDRMS lowers expenses by reducing paper use, storage needs, and manual labor. Compliance-related costs and penalties are also minimized.
• Improve Collaboration: EDRMS enables real-time co-authoring, secure sharing, and structured retrieval. Teams communicate more effectively and avoid duplication of work.
• Ensure Business Continuity: Using EDRMS safeguards records with backups, disaster recovery tools, and cloud access. Operations continue without disruption, with redundancy and rapid recovery in the event of system failures.
• Centralize Document Storage: EDRMS consolidates all files into a secure, version-controlled repository. Quick retrieval and reliable compliance are supported across the organization.
• Automate Workflows: The system of EDRMS routes documents through structured approval processes with alerts and deadlines. EDRMS helps ensure that every task is completed on time, with required approvals, and full traceability of all changes.
• Strengthen Version Control: EDRMS tracks document changes, restricts access to outdated files, and maintains revision histories. This helps ensure accuracy, accountability, and compliance.
• Scale with Growth: Using EDRMS allows organizations to expand with more users, documents, and workflows, supporting growth without compromising performance or compliance.
• Improve Accessibility: Cloud-based EDRMS provides secure access from any device or location. Remote and global teams work seamlessly with the same controlled information.

The benefits of an EDRMS are similar to the advantages of a DMS, but extend further by providing robust record management capabilities that support compliance, security, and long-term information governance.

How To Choose the Right EDRMS Solution?

To choose the right EDRMS for your needs, consider the following eleven steps.

1. Assess Your Document and Records Needs: Identify the types of documents and records you manage, their volume, and lifecycle complexity. Highlight current challenges, such as version conflicts, poor accessibility, and a lack of document tracking, to define system requirements.
2. Define Compliance and Regulatory Requirements: Document all applicable requirements like GDPR, HIPAA, and ISO 15489, that your EDRMS must support. Ensure the EDRMS includes features such as audit trails, metadata management, and retention schedules.
3. Determine Your Deployment Model: Decide between cloud-based, on-premises, or hybrid EDRMS. Align the choice with infrastructure, scalability goals, and security requirements, while considering IT staffing, maintenance, and future growth.
4. Evaluate User Roles and Access Control Needs: Define how many users will access the system and what permissions each role requires. Look for EDRMS solutions offering role-based access, encryption, and strong authentication features.
5. Research and Compare EDRMS Vendors: Collect details on system features, certifications, pricing, and vendor reputation through Requests for Information (RFIs) and Requests for Proposals (RFPs). Use comparison matrices to evaluate vendors objectively and identify the most suitable partner.
6. Review Integration Capabilities: Ensure the EDRMS integrates with ERP, CRM, PLM, and QMS platforms. Look for Application Programming Interfaces (APIs), pre-built connectors, and support for Single Sign-On (SSO) to streamline workflows.
7. Request Product Demonstrations: Schedule demos simulating real workflows. Test critical features such as automated retention, document tagging, version control, and overall usability.
8. Run a Pilot or Trial Program: Deploy a limited trial of the EDRMS within your organization to test real-world performance. Monitor adoption rates, efficiency improvements, and user feedback during the pilot.
9. Collect Stakeholder and User Feedback: Gather feedback from administrators, end users, and key stakeholders on usability and performance. Use this feedback to refine your requirements and guide final selection.
10. Evaluate Vendor Support, Training, and Scalability: Assess the vendor’s onboarding process, training resources, and customer support reputation. Confirm the EDRMS can scale with organizational growth without compromising compliance or performance.
11. Negotiate and Finalize the Selection: Use insights from pilots, demos, and evaluations to select the most aligned EDRMS. Negotiate licensing terms, implementation timelines, and ongoing support agreements.

What Is the Difference Between EDRMS and an Electronic Document Management System?

The difference between EDMS and EDRMS lies in their scope and functionality. An Electronic Document Management System (EDMS) is software designed to manage the creation, storage, retrieval, and version control of electronic documents. The main focus of an EDMS is to improve collaboration, streamline document workflows, and ensure that users always access the most current and accurate information.

An EDRMS is a more advanced solution that integrates EDMS with Records Management System (RMS) functionalities. An EDRMS manages active documents and controls compliant long-term records. Retention schedules, audit trails, and legal holds are applied to ensure regulatory and legal compliance.

While some EDMS platforms support certain records management features, not all provide the full compliance and governance capabilities of an EDRMS.

How Does EDRMS Differ From eQMS Software?

The main difference between an EDRMS and an Electronic Quality Management System (eQMS) software is that an EDRMS focuses on managing documents and records, while an eQMS software covers a broader range of quality management processes.

An EDRMS manages documents and records throughout their lifecycle. An EDRMS provides centralized storage, version control, retention schedules, audit trails, and legal holds to ensure secure, compliant, and traceable handling of information.

An eQMS software extends beyond document and records management by covering the full spectrum of quality processes. An eQMS enables organizations to manage document control, change management, training, CAPA, audit management, nonconformance, risk management, supplier management, equipment management, complaint management, and other quality processes.

An EDRMS secures and organizes documents and records, whereas an eQMS connects them with quality processes and compliance requirements, enabling companies in highly regulated fields to manage all QMS processes within a single system.

When Should You Choose a Specialized eQMS Over EDRMS Software?

You should consider choosing a specialized eQMS over EDRMS if your organization needs to manage not only documents and records but also broader quality processes such as training, CAPA, change control, audits, suppliers, and other processes. An eQMS is purpose-built for companies that need integrated workflows to manage quality processes, ensure compliance with applicable requirements, improve efficiency, and maintain full traceability.

The following are key scenarios of choosing eQMS over EDRMS software.

• Regulated Industries: Choose eQMS if operating in pharmaceuticals, biotechnology, or medical devices, where compliance with regulatory requirements is mandatory. Electronic QMS solutions are designed to operate in validated environments with secure audit trails and controls aligned with strict regulatory frameworks.
• Comprehensive Quality Management: Opt for eQMS when your organization needs to manage CAPA, nonconformance records, audits, supplier quality, risk, and other QMS processes in addition to document control. Unlike EDRMS, eQMS centralizes all quality processes in a single, integrated system.
• Regulatory and Inspection Readiness: Select an eQMS when validated systems with secure electronic signatures, FDA 21 CFR Part 11 or EU Annex 11 compliance, and complete audit traceability are essential. Unlike EDRMS, eQMS platforms integrate documents directly with broader QMS process workflows such as CAPA, audits, training, and risk management, strengthening inspection readiness.
• Scalability of Quality Processes: QMS software is preferable for organizations expanding across multiple departments or global sites. It enables standardized document control, training management, and quality workflows that scale consistently across distributed teams.

While an EDRMS is sufficient for general document and record management, companies in highly regulated industries or those requiring complete quality process control could benefit more by implementing an eQMS. An electronic QMS not only supports compliance but also integrates directly with quality processes, ensuring efficiency, traceability, and long-term business continuity across the entire quality process lifecycle.

To help you justify the investment in QMS software, you can download our free eQMS business case template (Excel + PowerPoint). The template allows you to input your company’s data, calculate potential benefits, and present results to management using ready-made professional slides.

For organizations in the life sciences industry, SimplerQMS provides a specialized life science eQMS solution that supports the full range of quality processes. SimplerQMS covers document control, training, CAPA, audits, supplier quality, risk management, among other processes, while supporting compliance with FDA 21 CFR Part 11 and Part 820, EU GMP, ISO 13485, ISO 9001, and other relevant life science requirements.