An Overview of Regulatory Management Software for Educational and Industrial Sectors

The eCTD (Electronic Common Technical Document) is a standardized format used to deliver regulatory information to Health Authorities (HAs), encompassing applications, supplements, and reports. It provides a uniform method for executing the Common Technical Document (CTD) over the internet. An eCTD consists of separate PDF files arranged in a hierarchy based on the CTD format. It also includes an XML framework that connects required documents and provides submission information. The aim of introducing eCTD was to reduce the pressure on reviewers. It also simplifies the submission process since all regulatory bodies use the same format.

The eCTD consists of five modules:

1. Information specific to the region
2. Condensed documents
3. Details regarding quality.
4. Reports of non-clinical studies.
5. Clinical research reports (CSRs).

We welcome eCTD submissions for these applications:

• New Investigational Drugs (NIDs).

• New Pharmaceutical Application (NPA)

• Abbreviated Applications for New Drugs (ANDA)

• Biologics License Applications (BLAs)

All applications submitted after the filing of the previously mentioned applications

All Master Files (MFs) included in the previously mentioned applications.

1. eCTD software:

eCTD (electronic Common Technical Document) software is a specialized type of software used in the pharmaceutical and biotechnology industries to create, manage, and submit regulatory documents to health authorities such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe.  The eCTD format is a standardized way to submit regulatory papers electronically. It organizes papers in a hierarchical framework and provides a standard method of naming, organizing, and formatting documents to aid regulatory agencies' review processes. Companies can use eCTD software to prepare documents that meet these criteria, validate them for compliance, and electronically submit them to regulatory organizations.

• Some common characteristics of eCTD software are:

Document management entails the ability to organize and manage documents in accordance with the eCTD structure, such as producing new documents, version control, and document linking.

Publishing and assembly: Tools for converting documents to the appropriate eCTD format, such as table of contents, bookmarks, and hyperlinks.

Validation: Automated validation checks verify that papers meet regulatory requirements and formatting norms.

Manage application submissions and communications with regulators.

Collaboration: Features that facilitate collaboration between team members involved in the regulatory submission process, including commenting, version control, and workflow management.

Regulatory updates: Tools to stay up-to-date with changes in regulatory requirements and guidelines. Overall, eCTD software helps streamline the regulatory submission process, reduce errors, and improve efficiency for pharmaceutical and biotech companies seeking approval for new drugs and medical products.

1: eCTD Office:

       
           
       
eCTD Office is an all-in-one software tool designed for generating, validating, and overseeing eCTD submissions. Created by EXTEDO, it is extensively utilized by pharmaceutical firms and regulatory bodies worldwide. • eCTD Office comprises a collection of interconnected software tools for generating, validating, publishing, viewing, and handling regulatory documents for electronic submissions from pharmaceutical companies to regulatory agencies. Compile, validate, publish, view, and manage the lifecycle of your electronic submissions. • Compile: Prepare your submission files and complete the supplied region-specific approved template. Add documents manually or import/merge existing eCTD/Nees. • Validate: Integrated validation that adheres to regional regulations guarantees that no invalid submission can be produced.

• Publish: Set it and forget it. No requirement to understand eCTD XMLs or any other IT-related elements of eCTD/NeeS. NeeS TOC files are automatically created and enhanced
• View: Gain insight into howAuthorities perceive your electronic submission. Shorten review durations, enhance response times to Agency inquiries, and guarantee quicker product approvals.
• Manipulate: In the background: effortlessly split and merge your PDF files, convert MS Word DOC to PDF, specify document Titles, attributes, granularity, envelope values.
• Manage lifecycle: Simple as pie. comprehendand oversee your eCTD products lifecycle as straight forward as “assign – operation-target.”

2.Regulatory Information Management (RIM) Systems: 

These systems assist in overseeing regulatory data and submissions across the product's lifecycle. RIMS, which stands for Regulatory Information Management System, is a centralized software platform designed to streamline the tracking of product application and registration lifecycles in the Regulatory industry. It allows comprehensive monitoring of regulatory actions connected to various types of products such as pharmaceuticals, biologics, and cosmetics, among others.
RIMS significance: 

Throughout time, the submission management process in the regulatory field has evolved into a complex and demanding task. A strong RIMS system can assist in coordinating tasks during the entire duration of product development and pharmaceutical marketing.RIMS enhances Regulatory business planning and streamlines the Product Registration procedure to monitor and oversee all Regulatory tasks and their life cycles. It also prevents redundant work and simplifies product applications and operations for submission. In summary, RIMS was created to eliminate duplication and reduce manual work.

Capabilities of RIMS
• Lowers the effort and duration needed to achieve Regulatory compliance related to products and regulatory bodies.
• Provides transparent management of lifecycle regulations
• Efficiently handles the inquiries from Health Authorities following submission.
• Assists in effortlessly handling commitments, variations, and obligations
• Monitors applications for marketing approval and lifecycle management
• Monitors files for changes in products and regulatory bodies.
• Monitors changes, evaluations of documents, and item details
• Fulfills regulatory requirements for electronic systems, including 21 CFR Part 11.
• Enhances efficiency and teamwork through faster and higher-quality submissions.

RIMS function:

RIMS integrates document and data management solutions with product registration and lifecycle tracking to enhance Regulatory development worldwide. The tool primarily facilitates comprehensive Regulatory data management. It fundamentally comprises: -

• Product data management
• Product registration management
• Product registration lifecycle management
• Dossier management
• Article 57 & IDMP compliant
• Easy to configure dashboard & reports

eCTD & eDMS filing software, electronic document management system for regulatory pharmaceutical use.

Description: PharmaReady™ is a comprehensive web-based eDMS and eCTD Submissions Solution Suite. PharmaReady is specially created for regulated Life Science organizations, focusing on ease of installation, user-friendliness, compliance, and cost-effectiveness as key business factors. PharmaReady is offered in both on-site and remote-hosted formats.

Knowledge NET is a comprehensive publishing tool designed for the creation, validation, publishing, viewing, and reporting of regulatory documents for electronic submissions by pharmaceutical firms to regulatory bodies.

KnowledgeNET is a comprehensive, feature-rich, and well-established solution for dossier submission and lifecycle management.

It demonstrates excellent flexibility in assembling documents that comply with diverse international regulatory standards across different publishing formats such as CTD, eCTD, NeeS, ACTD, GTD, vNeeS, and regional formats.

It comes equipped with built-in checklists and template frameworks for the US, EU, Gulf (GCC), Africa, Australia, Asia, CIS, and Latam regions, which can accelerate the dossier compilation process by over 60%.

Features:

• Dossier project monitoring and life cycle administration
• Management of dynamic template structures
• Formatted document publication
• Reusing documents (upload once and utilize in various dossiers)
• Project status overview and Management Information System
• Establish the default working project
• Auto correction of PDF attributes according to the guidelines.
• Immediate alerts and notifications to relevant users
• Document conversion, such as word to pdf.
• Attributes at the project level, including submission, MA grant, and approval dates

ADVANTAGES:

• Remove the chance of failing to comply.
• Enhancement of submission efficiency
• Remove delays caused by inquiries.
• Minimize reliance on users
• Minimize the time needed for dossier preparation.
• Integrated document search tool
• Management of queries after submission
• User proficiency in various formatting tools is not necessary.
• A single solution for all forms of submission (PDF, HTML, and XML publishing)
• Unified solution for overseeing international publishing

DocuBridge is a sophisticated electronic management system for submission and regulatory content, designed for compiling, publishing, importing, and reviewing. As an eCTD publishing instrument, it is also beneficial for additional regulatory submission formats such as (V) NeeS, HTML, PDF, and paper.

DocuBridge ONE: is our individual user publishing solution. It is tailored specifically for individuals creating national eCTDs or VNeeS on a single-user PC or laptop with low output.

DocuBridge TWO: is our uniform multi-user publishing solution. It is ideal for small to medium-sized businesses with two or three users creating eCTDs or VNeeS across up to two distinct regions. Furthermore, it provides an optional integrated regulatory DMS.  DocuBridge FIVE: is our customizable modular multi-user publishing platform. It is ideal for medium to large companies with at least five users creating eCTDs and/or various publishing formats across different areas, along with regulatory bodies. With its various interfaces, it can integrate into your adaptable RIM solution.

         
           
       
Document management systems (DMS):

DMS software aids in structuring and overseeing the documents necessary for eCTD submissions. Instances include Veeva Vault and Master Control.

Veeva Vault is a genuine cloud-based enterprise content management system and a collection of applications designed specifically for life sciences.  Historically, businesses needed to implement applications for content and different applications to handle related data. Veeva Vault stands out as the sole content management platform that uniquely manages both content and data.  Since all Vault applications share the same core platform, organizations achieve enhanced efficiency and compliance via the smooth movement of documents across different regions and departments. Content remains available, up-to-date, and relevant throughout the complete development and commercial lifecycle.

Master Control

• Master Control Submissions Ready Docs™: This software offers a comprehensive document management solution tailored for regulatory submissions. It includes submission-specific document templates and preconfigured document types. Its collaboration features and MS-Word integration facilitate teamwork on submission documents while maintaining security and reliability.
• MasterControl Submissions Locker™: A secure, web-based repository for controlling access to submission documents. This is ideal for companies that outsource eCTD document construction. It allows authenticated access for third-party publishing tools, with access rights managed via MasterControl login credentials.
• MasterControl Submissions Gateway™: This tool simplifies sharing approved submission documents in the required folder structure with publishing groups or contractors. It is recommended for companies that outsource eCTD functions instead of using eCTD software.

7. Submission tracking and lifecycle management tools:

These tools help in tracking the status of submissions and managing their lifecycle. Examples include Liquent Insight and Ennov RIM.

To illustrate the main characteristics and advantages of eCTD Assistant 2.0, we can develop a chart detailing its functionalities, advantages, and supported features. Here is a straightforward chart that encapsulates the information given:

Benefit and their description.

Compliant eCTD Submissions - Quickly create compliant eCTD submissions for multiple regions.

XML backbone - Utilizes XML backbone for easy and automatic tracking of submission updates.

Technical details - Frees users from XML technicalities, providing a rules-based processing engine.

Template updates - Updates templates to accommodate new ICH and regional requirements quickly.

Supported specifications - Supports final ICH Step 4 eCTD specifications and draft specifications from FDA and EMEA.

Integration - Direct integration with Microsoft Windows file system and Documentum simultaneously.

Document organization - Assemble and organize submission-ready documents, create file/folder structure, and build XML backbone for submissions.

2. Ennov RIM.

Ennov dossier streamlines the development of electronic (eCTD, NeeS, VNeeS, eCopy) and paper regulatory submissions through a single user interface.

It is completely web-based, enabling smooth integration across various locations or globally scattered teams.  The platform provides user-friendly submission assembly tools designed for efficiently capturing and managing eCTD metadata.  Users can conveniently drag and drop files from Ennov Doc or any Web Dav repository into the submission assembly interface.  Templates for submission assembly can be found for regions that accept eCTD submissions and can be tailored to meet particular needs.  Ennov Dossier offers a thorough and adaptable solution for submission publishing that is appropriate for operations of any size.  The output produced by Ennov Dossier adheres to all existing standards set by regulatory agencies.

8. Global Submit™ eCTD Software:

With eCTD submissions management software, your regulatory team will have the necessary tools to effectively publish, validate, and review your eCTD submissions. This implies you can reduce risk and skip unnecessary procedures with a simplified eCTD submission process that aids your regulatory team in their urgent efforts to meet deadlines and provide treatments to patients. “For a group with limited time to prepare and verify a submission, GlobalSubmit is an excellent platform since it is fully integrated, featuring both CROSSCHECK and VALIDATE.” Thus, you understand that when you create the submission, it meets compliance, and there's no need for an additional tool for validation.

Function:

CROSSCHECK – Verify your hyperlinks and bookmarks for quality control (QC) 8 times quicker and 3 times more precisely than slow, conventional manual techniques.

• LINK – Efficiently and precisely produce regulatory compliant PDF documents, handle 10 GB of data in just minutes, and generate 1,000,000 hyperlinks every hour.

• Real-time validation – Detect and rectify your mistakes instantly

• Delta publishing – Publish only the revisions as changes are made at the last minute.

9. Airs Global lifes phere ECTD

LifeSphere Publishing provides you with the opportunity to:

Facilitate collaboration between Regulatory Affairs and Regulatory Operations teams to guarantee prompt and precise submissions.

Verify that submissions are checked beforehand for precision, thoroughness, and adherence to regulations.

Advantages:

Smooth integration with regulatory information management, document management, and dossier management systems provides companies with extensive functionalities throughout the product regulatory lifecycle.  A user-friendly, intuitive, and mobile-compatible interface improves the experience for users when compiling, publishing, and validating their submissions.  Integrated document management features with lifecycle and workflow oversight actively guide users through designated tasks.  Management and support of the eCTD submission lifecycle for FDA applications and submissions guarantee adherence to compliance.  A pre-validated deployment on the cutting-edge Amazon Web Services (AWS) cloud removes the necessity for internal infrastructure and expensive upgrades.

10. Freyr Publishing and Submissions

Freyr helps Life Sciences organizations optimize the complete Health Authority (HA) submission management process, starting from dossier creation, submission strategy, monitoring, publishing, and final submissions to HA, which includes confirmation of delivery/acknowledgment, ensuring accurate, prompt, and high-quality submissions during the submission lifecycle. Freyr specializes in Regulatory publishing services, assisting with paper, electronic, eCTD, and NeeS submission formats. Freyr offers a versatile publishing and submission software, Freyr SUBMIT, which allows companies to efficiently fulfill all their distinct Regulatory submission needs for quicker and more effective approval of Drugs, Biologics, and Medical Devices by international Health Authorities (HAs).  Freyr’s aim is “To serve as the vital partner in navigating global regulatory challenges and ensuring the safe and compliant distribution of products in local markets.” To achieve success, we must initially have faith in our abilities, and we firmly believe that the future is not merely a place we enter, but rather something we forge ourselves.  We are here to establish a compliant route for our customers' entry into global markets.

Quick Facts:

• • 250+ Experts
  • 200+ Customers
  • 150,000+Total submissions
  • 25000+ NeeS Submissions
  • 77000+ LCM eCTD
  • 400+ MAA Submissions

Definition:  Compliance management software is intended to assist organizations in assessing and overseeing if a product adheres to relevant laws, regulations, and internal standards, along with the expectations of customers and business associates. The software allows businesses to digitally monitor and manage documentation including policies and procedures, employee training files, corrective and preventive actions (CAPAs), and customer complaints. No matter the industry or type of product, the software solution must facilitate the control and management of compliance documentation. For example, firms in the high-tech and consumer electronics sectors need to keep documentation of materials compliance for environmental regulations such as RoHS, REACH, and conflict minerals. Conversely, manufacturers of medical devices need to manage processes and documentation that are particular to FDA 21 CFR Part 11 and 21 CFR Part 820.

Quality Management Software:

Quality management software is a digital platform that automates and streamlines quality management processes, ensuring compliance with standards and regulations. It facilitates the systematic management of quality policies, procedures, and documentation. Implementing an electronic QMS (eQMS) helps manage processes like document control, change management, training, audits, nonconformance, CAPA, and supplier management efficiently.

How Compliance Management Systems Work

• Integrating the different facets of regulatory compliance
• Designing and implementing internal compliance policies
• Enforcing compliance across the organization
• Regularly checking for noncompliance
• Managing noncompliance risk
• Incorporating external stakeholders
• Updating the compliance management system

Quality management system software for:

Quality management system (QMS) software helps companies streamline and automate quality management processes, improve efficiency, and ensure compliance with regulatory and customer requirements. It is especially crucial for highly regulated industries like Life Sciences, where adherence to standards is vital for success and safety. SimplerQMS offers eQMS solutions tailored for Life Science companies, addressing the specific quality management needs of sectors such as pharmaceuticals, biotechnology, medical devices, CROs, and CDMOs.

Benefits of Using Electronic QMS:

?Improved Compliance:

QMS software ensures adherence to regulatory and customer requirements through predefined workflows, automatically documenting actions in a time-stamped audit trail.

?Enhanced Efficiency:

By automating and streamlining quality management processes, QMS software reduces manual effort, minimizes errors, and boosts productivity and operational efficiency.

?Increased Transparency:

Real-time visibility into quality management activities allows employees to access relevant data, fostering accountability, collaboration, and informed decision-making.

?Cost Savings:

QMS software reduces manual paperwork, streamlines processes, and eliminates non-value-adding tasks, leading to cost savings through improved efficiency, reduced waste, and decreased risk of noncompliance.

Best QMS Software Solutions for Life Sciences:

• Simpler QMS: Tailored for Life Science industries like medical devices, pharmaceuticals, and biotechnology. Known for its comprehensive support, ease of use, and GAMP5 validation.
• Qualio: Ideal for growing Life Science companies and start-ups, featuring a web-based document editor for transparent management.
• MasterControl: Suitable for large enterprises, offering document control and quality management compliant with FDA 21 CFR Part 11.
• TrackWise: Known for AI-augmented decision-making, catering to industries like pharmaceuticals and biotechnology.
• Ideagen Quality Management: Offers a broad range of QMS modules and Microsoft Office integration, with e-learning capabilities.
• Greenlight Guru: Cloud-based QMS for MedTech, featuring requirements management and traceability matrix capabilities.
• Dot Compliance: Features an AI assistant, Dottie AI, for scanning and analysing data, providing real-time insights.
• QT9: Web-based eQMS with over 23 built-in modules for various industries, including medical devices and pharmaceuticals.
• Scilife: Comprehensive QMS modules validated according to GAMP5, hosted on the AWS platform, designed for Life Sciences.

Regulatory Compliance Management Software

Regulatory compliance management software helps organizations identify the regulations, policies, and obligations that are relevant to them both globally and at specific locations. It allows them to oversee alterations to policies.

• Regulatory compliance management software works:

The required infrastructure may vary based on your regulatory compliance software provider. It’s entirely connected to the strength of their solution. risingMax Inc. provides API-first regulatory compliance software, simplifying the integration with your existing banking system or CRM. All regulatory materials are obtained from a top international law firm with which we are proud to partner.  The aim is for you to consistently have access to current regulatory information in addition to your existing tools. Smooth, user-friendly, and no extra equipment needed.

• Regulatory compliance management software do:

Document management: Streamline and systematize the method of producing, storing, and overseeing all your documents in a single location.

Change control: Ensure that every modification to your QMS is recorded and authorized, maintaining adherence to regulatory standards.

Employee training: Automate and simplify the whole employee training procedure to make it quicker, more cost-efficient, and more compliant.

CAPA management: Combine your CAPA management process with the complete product life cycle for an all-encompassing perspective of your organization's QMS.

Supplier management: Optimize supplier documentation procedures, monitor supplier performance, and guarantee supplier quality and adherence to standards.

Audit management: Automate numerous tasks associated with audits, including creating and overseeing audit schedules, gathering data, producing reports, and beyond.

Quality management: Simplify quality procedures and effortlessly adhere to regulatory compliance standards.

Audit management: Streamline your audit processes and enhance your readiness for audits.

Risk management: Streamline risk and manage your risk management documentation in an orderly and systematic way.

Supplier management: Streamline activities related to suppliers and manage your supplier documentation in accordance with the standards.

Document Management Software

Document management software offers a central location for the electronic storage, management, and retrieval of documents. Using it, you can manage, access, and distribute information without sifting through piles of documents in multiple nine-square-foot filing cabinets. Along with storage and sharing, document management services offer tools to automate the complete document lifecycle, enhancing internal processes and boosting productivity.

While conversing with specialists and evaluating these document management services, I refined the suggestions according to several essential criteria:

• Purpose-built document management abilities: The primary distinction between cloud storage applications and a document management service lies in the workflow. Although cloud storage services primarily gather, save, and distribute files, document management systems arrange, oversee, and direct the documents. The applications I have listed here concentrate primarily on managing documents.

• Workflow automation: Workflows encompass document generation, routing, updates, archiving, approvals, and all other automated tasks that enhance efficiency. Effective DMS software ought to include integrated workflows and automated regulations for the storage, organization, and tagging of documents.

• Improved security: Document management services offer integrated protection to ensure your files are secure. By utilizing features such as access control and audit trails, you can oversee actions related to each file and determine who is allowed to access what. As DMS software is typically cloud-based, your files are protected from physical damage and loss.

• Collaborative tools: With document management software, one should have the ability to share and work together on documents in real-time, keep track of changes, oversee workflows, and manage document versions.

• Data acquisition features: DMS software employs optical character recognition (OCR) technology to convert paper documents into digital formats, allowing you to bypass the data input phase of document management.

• Usability: An excellent document management system must be user-friendly and easily adoptable, even for those who are not tech-savvy. Administrators must possess full authority and control over their documents, with files being straightforward to track, manage, and distribute.