Electronic document management system for the pharmaceutical industry
Here at Agatha, we have a technology-based solution called an electronic document management system (EDMS) that enables pharmaceutical organizations to effectively manage their papers, records, and information throughout the entire clinical process. In order to ensure regulatory compliance with industry standards like current good manufacturing practices (CGMP), good laboratory practices (GLPs), and 21 CFR Part 11, our approach offers a central repository for all documents in a variety of formats, including electronic signatures and version control.
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Reduce the risks related to regulatory compliance
The risk connected to regulatory compliance and quality procedures can be greatly reduced by EDMS, making it a crucial tool for pharmaceutical firms. An eDMS offers a trackable, reportable audit trail of all operations, including document production, alteration, and review.
The pharmaceutical sector is extensively regulated, and EDMS offers a way to make sure that regulatory standards like the International Council for Harmonization, the Federal Food, Drug, and Cosmetic Act, and new drug applications are followed.
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Integrate your eDMS with other systems
To provide a streamlined method of handling pharmaceutical documentation, an EDMS also connects with other systems including Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP), and IoT devices. Solutions for EDMS that are hosted in the cloud, like SharePoint and other cloud platforms, have the added benefits of accessibility, teamwork, and cost reduction.
By using EDMS to manage their quality management system (QMS), pharmaceutical businesses may make sure that CGMPs, GLPs, and other quality requirements are followed. It is a crucial tool in the life sciences domain since it lets the companies manage the entire drug research, clinical trial, and post-market surveillance process.
Key features of our electronic document management system for pharmaceutical industry
Pharmaceutical firms may successfully manage their papers, records, and information with the aid of an Electronic Document Management System (EDMS), which is a potent tool for operations management. To suit the specific needs of the pharmaceutical business, an EDMS should contain the following important characteristics:
Document capture and scanning
EDMS should support document capture and scanning so that paper-based records can be digitally preserved and made easily searchable. Particularly in an organization with a high amount of paper-based documents, this capability enables quicker and more effective document management.
Document indexing and retrieval
The EDMS should include a strong indexing and retrieval system that makes it possible for users to find documents quickly and easily. Also, it ought to support various file types including Word, Excel, and PDF.
Document versioning and control
To guarantee that users are working on the most recent version of a document, an EDMS should have document versioning and management. Moreover, it should keep track of updates and offer an audit trail of document changes.
Document audit trails and reportings
The EDMS should feature a document audit trail and reporting system that makes it possible to track all document-related operations, such as creation, alteration, and review. This function guarantees responsibility and compliance with regulations.
To increase productivity and lower the risk of errors, EDMS should automate document management procedures. The automatic routing of papers for approval, review, and publication is made possible by workflow automation.
Integration with current systems
To provide a seamless approach to managing pharmaceutical documentation, EDMS should interact with other systems including Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP), and IoT devices.
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Why should you choose Agatha’s electronic document management system for the pharmaceutical industry?
Great workflow management
We provide strong workflow management tools as part of Agatha’s eDMS. By providing effective and centralized control, our workflow creation and management solutions make it easier for your company to create, modify, archive, version, and share documents.
You’ll have a better understanding of the breadth of the work being done by your team and be able to more effectively coordinate tasks thanks to our workflow management tool. Our user-friendly interface reduces the learning curve and ensures that your team can get up and running right away. It’s simple to develop and manage workflows.
Design your own workflow
You may design workflows to meet the unique requirements of your company thanks to the customizability of our workflow management features. You may boost overall productivity and streamline your document management procedures with Agatha’s eDMS.
Obtain effective reporting
Agatha’s eDMS provides a comprehensive reporting system for pharmaceutical companies, allowing for easy generation of reports tailored to specific needs. The system generates reports in various formats such as PDF, XML, and XLS, providing better convenience to users. Additionally, the platform allows users to apply many filters and display data in different reporting styles, enabling users to customize the reports according to their specific requirements. With Agatha’s eDMS, pharmaceutical companies can efficiently monitor their inventory status, sales, and other critical business metrics through its robust reporting system.
Agatha's eDMS's user-friendly dashboard
Agatha is aware of how important a user-friendly dashboard is to the functionality of the eDMS. Our eDMS offers a user-friendly interface that makes it possible for employees to navigate effectively without needing to conduct any extraneous actions in order to complete their jobs. Our dashboard features a list of tasks, settings, visible notifications and alerts, an embedded calendar and email, a menu to see reports, and other items required to carry out document-related duties.
Further features of our eDMS can be added to fulfill the particular requirements of your pharmaceutical company. We have an offline option, for instance, that enables you to function without an internet connection. Additionally, we may combine our eDMS with outside providers to offer a comprehensive document management solution.
Take a look at our guide to discover more about our electronic document management system for the pharmaceutical industry
Check out our in-depth guide to discover more about document management software, its features, and advice for picking the best option. At Agatha, we are dedicated to offering the highest quality eDMS with cutting-edge capabilities that guarantee success in the pharmaceutical sector.
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The benefits of using electronic document management system for pharmaceutical industry
Pharmaceutical firms can profit greatly from using an Electronic Document Management System (EDMS) in the pharmaceutical sector. Some of the primary advantages are as follows:
Increased productivity and efficiency
EDMS streamlines document management procedures, cutting down on the time needed for document searching and review. The productivity of an EDMS can be increased, making document management considerably simpler and more effective with features like document capture and scanning, indexing and retrieval, and workflow automation.
Improved security and compliance
The pharmaceutical business is subject to stringent regulations, and EDMS offers a solution that guarantees adherence to industry standards including current good manufacturing practices (CGMP), good laboratory practices (GLPs), and 21 CFR Part 11. Version control, document audit trails, and electronic signatures are EDMS capabilities that increase security and help organizations comply with legal obligations.
Increased accessibility and collaboration
By offering a centralized repository for all documents, EDMS facilitates improved accessibility and cooperation. This method guarantees that documents are easily accessible to authorized individuals, regardless of where they are located or what department they are employed in. By enabling teams to work on the same document simultaneously, track changes, and look over comments, EDMS also makes it easier for teams to collaborate.
As paper-based documentation is no longer necessary, there is a decrease in the cost of printing, maintaining, and managing paper-based information. By automating manual operations and lowering errors, it also saves time and resources. By obviating the requirement for hardware and maintenance expenditures connected with on-premise systems, cloud-based EDMS solutions, such as SharePoint and other cloud platforms, offer further cost benefits.
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FAQ about electronic document management system for pharmaceutical industry
What is the approach to implementing eDMS in pharmaceutical companies?
The approach to implementing eDMS in pharmaceutical companies involves identifying the document management requirements, evaluating the available document management software solutions, selecting the most suitable eDMS system, and integrating the software with the company’s existing systems. The implementation process includes planning, testing, training, and ongoing maintenance to ensure that the system is functioning optimally.
What kind of content can be managed using eDMS in the pharmaceutical industry?
eDMS can manage a wide range of content in the pharmaceutical industry, including product specifications, batch records, clinical trial data, regulatory filings, quality processes, and standard operating procedures. The system also supports various file formats, including PDF, Microsoft Word, and Excel.
How does eDMS help with regulatory requirements?
eDMS helps with a wide range of regulatory requirements by providing a single source of truth for all documents related to regulatory compliance. It ensures that documents are stored securely and are easily accessible when required for audits or inspections. eDMS also provides features such as electronic signatures, version control, and document control systems that comply with regulatory standards such as current good manufacturing practice (CGMP), 21 CFR Part 11, good laboratory practices (GLPs), and the Federal Food, Drug, and Cosmetic Act.
What are some compliance issues that can be addressed by using pharmaceutical document management software?
Compliance issues that can be addressed by using pharmaceutical document management software include ensuring product quality, maintaining a pharmaceutical quality management system (QMS), meeting regulatory requirements, and managing electronic records. The software also helps to ensure that all document management activities are performed in accordance with good manufacturing practice (GMP) standards.
How does eDMS help to ensure product quality in pharmaceutical manufacturing?
eDMS helps to ensure product quality in pharmaceutical manufacturing by providing a centralized repository for managing product specifications, batch records, and other quality-related documents. The system also provides features such as electronic batch records and integrated document management that help to streamline quality processes and reduce the risk of errors or inconsistencies.
How can a pharma DMS assist in complying with the most crucial regulation in the pharmaceutical industry?
A Pharma Document Management System (DMS) is helpful in assuring compliance with the regulatory requirements of the pharmaceutical sector. A pharma DMS’s main goal is to digitally organise and safely store important paperwork. The system’s features can be used to comply with industry norms and rules, such as those established by the FDA and GMP.
How does eDMS help organize document control requirements in the pharmaceutical industry?
eDMS helps with document control requirements in the pharmaceutical industry by providing features such as version control, electronic signatures, and access controls. It ensures that documents are stored securely and that changes are tracked and auditable. eDMS also helps to ensure that only authorized users have access to specific documents and that access is granted based on roles and permissions.
How does eDMS support clinical research organizations?
eDMS supports clinical research organizations by providing a centralized repository for managing clinical trial data and regulatory filings. It helps to streamline the document management process and ensure compliance with regulatory requirements such as the International Council for Harmonisation (ICH) guidelines. eDMS also helps to improve collaboration between different teams involved in clinical research.
Glossary about Electronic Document Management Systems for the pharmaceutical industry
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