QuickFlow LIMS
Laboratory Information
Management System
Quickflow eSheet
Calculation Sheet
Quickflow QMS
Quality Management
System
Quickflow DMS
Document Management
System
Quickflow - Document Management System
With audit trails and version control, our system optimizes pharmaceutical document processes, including SOPs, STPs, Protocols, and more. This enhances control, organization, and accessibility, revolutionizing documentation practices.
- Overview
- Challenges
- Features
- Key Benefits
Overview
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Major pharmaceutical companies generate and oversee a vast amount of intricately interconnected Documents. In order to mitigate risks, guarantee patient safety, comply with regulatory standards, and expedite the drug-to-market process, pharmaceutical firms consistently seek innovative technologies and methods to streamline their workflows, simplify complexity, and enhance the efficient use of Documentation. A prevalent technological solution employed by Pharmaceutical and clinical organizations for storing and overseeing document process is a Document Management System (DMS).
QuickFlow eDMS addresses the challenges by offering a power-packed solution designed for the unique needs of Pharmaceutical and Biotech companies, ensuring compliance with cGMP requirements, including 21CFR Part 11 and EU Annex 11.
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Quickflow Electronic Document Management System (eDMS) is a software application that allows organizations to manage and store electronic documents such as Standard operating Procedures (SOP), Protocols, Standard Testing procedures (STP) etc. in a centralized repository. It provides a secure, organized, and efficient way to manage documents, from creation to distribution, storage, retrieval and Version control.
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Our software offers a user-friendly interface that allows you to easily track the progress of DMS activities on real time basis also our software is complaint with USFDA 21 CFR Part-11, EU-Annexure-11 guidelines and other regulatory standards.
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But that's not all - our software is highly configurable and can be tailored to your specific DMS needs. Plus, with real-time visibility into your DMS activities.
The adoption of QuickFlow eDMS represents a strategic move for organizations to enhance efficiency, compliance, and competitiveness in an industry marked by rapid advancements and stringent regulatory requirements. The system provides a robust foundation for maintaining the integrity of documentation, streamlining processes, and meeting the evolving demands of the pharmaceutical and biotechnological landscape.
Industry Challenges
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⦿ Time-consuming:
One of the major challenges in the Document Management System is the process of manual document preparation. It is a time-intensive process because collaboration between teams may not be streamlined and can lead to extension in time frames.
⦿ Chances of losing document:
In manual Document Management Process, there is always a danger of losing the document as the entire procedure is manual. The user can misplace the document. As a result, it might not be available when it is required.
⦿ Version tracking:
One of the major challenges in the manual document management process which leads to lots of regulatory observations for many companies is to maintain a track of versions. There is always a possibility of unavailability of the latest version of the document because the entire process of document updating is manual and there is no track of activities.
⦿ Error-prone:
The manual process of managing documents can be prone to human error, which can result in non-compliance with regulations and standards. This can lead to quality issues, customer complaints.
⦿ Storage and retrieval:
Manual records take up physical space and can be difficult to store and retrieve, especially if records are lost or damaged.
⦿ Inefficiency:
Takes more time for records retrieval during the audits, which in turn decreases the efficiency.
⦿ Lack of Audit Trials:
Manual DMS systems does not have facility to capture the audit trials for the performed activities.
Features
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⦿ Efficient Management of DMS Activities:
âž® The e-DMS system streamlines Document Management System (DMS) activities, encompassing Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), and Protocols.
âž® Processes such as initiation, review, and approval are seamlessly conducted online, reducing manual intervention and enhancing efficiency.
⦿ Electronic Signatures and Activity Stamps:
âž® The system employs electronic signatures and activity stamps, ensuring the authenticity and traceability of every document-related action.
âž® Electronic signatures add a layer of security and validation to the approval process, replacing traditional handwritten signatures.
⦿ Customizable Templates for Quality Needs:
âž® The software provides customizable templates adaptable to specific Quality requirements, facilitating easy modifications to reflect changes in processes.
âž® This customization ensures that the documentation aligns precisely with the organization's quality standards and evolving needs.
⦿ Adaptable Document Numbering Format:
âž® The document numbering format is flexible, allowing organizations to adapt it to align with their SOP requirements.
âž® This adaptability ensures consistency and compliance with internal document control procedures.
⦿ Categorization for Efficient Approval Process:
âž® Documents can be categorized based on complexity, streamlining the approval process by allowing for tailored workflows depending on the nature of the document.
âž® This categorization enhances efficiency and ensures that the right personnel are involved in the approval process.
⦿ Print Controls and Restricted Access:
âž® Print controls are in place, limiting the physical reproduction of documents to authorized personnel.
âž® Access to sensitive documents is restricted, reducing the risk of unauthorized viewing or modification.
⦿ Role-Based Access Controls for Data Security:
âž® Role-based access controls are implemented, ensuring that users have access only to the information necessary for their roles.
âž® This enhances data security by preventing unauthorized access to sensitive documents and data.
⦿ Data Integrity and Compliance:
âž® The system aids in maintaining data integrity and ensures compliance with relevant regulatory standards and industry requirements.
âž® This is crucial for industries where adherence to standards is paramount for quality, safety, and legal reasons.
⦿ Clear Audit Trails and Version Control:
âž® The system transparently records all changes made to documents, providing clear audit trails and version control.
âž® This feature is essential for compliance purposes and allows organizations to track and understand the evolution of each document.
⦿ Automatic Alerts and Notifications:
âž® The system incorporates automatic alerts and notifications, enhancing communication and ensuring timely issue resolution.
âž® Users are promptly informed of pending approvals, upcoming document reviews, or any other relevant actions, improving overall workflow efficiency.
⦿ Electronic Signature and Validation for Compliance:
âž® Electronic signatures and validations contribute to upholding data integrity and compliance with regulatory standards.
âž® This feature ensures that document approvals and changes are legally binding and meet the necessary regulatory requirements.
⦿ Centralized Data Storage and Cloud-Based Deployment:
âž® The system provides centralized data storage, offering easy access to historical records for reporting and analysis.
âž® Cloud-based deployment ensures accessibility and security for all users, regardless of their physical location, promoting collaboration and remote work capabilities.
Key Benefits
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⦿ Increased Efficiency:
e-DMS software streamlines with the Document  process, reducing errors and saving time.
⦿ Automated Reporting:
The software automates report generation, saving time and reducing the risk of errors associated with manual document preparation.
⦿ Customizable Templates:
e-DMS software offers customizable templates, allowing you to tailor the software to your specific DMS needs.
⦿ Document Security:
Accesses controls can be restricted to authorized persons for sensitive documents.
⦿ Regulatory Compliance:
The software helps ensure compliance with regulatory requirements by providing accurate and up-to-date documentation.
⦿ Improved Communication:
e-DMS software enables easy communication between team members, ensuring everyone is on the same page.
⦿ Enhanced Collaboration:
The software facilitates collaboration between different departments, improving efficiency and reducing delays.
⦿ Cost Savings:
By reducing errors and streamlining processes, e-DMS software can save you money on production costs.
⦿ Scalability:
The software is scalable, allowing you to easily adapt it to the changing needs of your business.
⦿ Reduced Paperwork:
e-DMS software eliminates the need for manual record-keeping, reducing paperwork and the associated risks of errors
