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
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.
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.
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.
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
⦿ 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
⦿ Efficient Management of DMS Activities:
➮ The e-DMS system streamlines Document Management System (DMS) activities, encompassing Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), and Protocols.
➮ Processes such as initiation, review, and approval are seamlessly conducted online, reducing manual intervention and enhancing efficiency.
⦿ Electronic Signatures and Activity Stamps:
➮ The system employs electronic signatures and activity stamps, ensuring the authenticity and traceability of every document-related action.
➮ Electronic signatures add a layer of security and validation to the approval process, replacing traditional handwritten signatures.
⦿ Customizable Templates for Quality Needs:
➮ The software provides customizable templates adaptable to specific Quality requirements, facilitating easy modifications to reflect changes in processes.
➮ This customization ensures that the documentation aligns precisely with the organization's quality standards and evolving needs.
⦿ Adaptable Document Numbering Format:
➮ The document numbering format is flexible, allowing organizations to adapt it to align with their SOP requirements.
➮ This adaptability ensures consistency and compliance with internal document control procedures.
⦿ Categorization for Efficient Approval Process:
➮ Documents can be categorized based on complexity, streamlining the approval process by allowing for tailored workflows depending on the nature of the document.
➮ This categorization enhances efficiency and ensures that the right personnel are involved in the approval process.
⦿ Print Controls and Restricted Access:
➮ Print controls are in place, limiting the physical reproduction of documents to authorized personnel.
➮ Access to sensitive documents is restricted, reducing the risk of unauthorized viewing or modification.
⦿ Role-Based Access Controls for Data Security:
➮ Role-based access controls are implemented, ensuring that users have access only to the information necessary for their roles.
➮ This enhances data security by preventing unauthorized access to sensitive documents and data.
⦿ Data Integrity and Compliance:
➮ The system aids in maintaining data integrity and ensures compliance with relevant regulatory standards and industry requirements.
➮ This is crucial for industries where adherence to standards is paramount for quality, safety, and legal reasons.
⦿ Clear Audit Trails and Version Control:
➮ The system transparently records all changes made to documents, providing clear audit trails and version control.
➮ This feature is essential for compliance purposes and allows organizations to track and understand the evolution of each document.
⦿ Automatic Alerts and Notifications:
➮ The system incorporates automatic alerts and notifications, enhancing communication and ensuring timely issue resolution.
➮ 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:
➮ Electronic signatures and validations contribute to upholding data integrity and compliance with regulatory standards.
➮ This feature ensures that document approvals and changes are legally binding and meet the necessary regulatory requirements.
⦿ Centralized Data Storage and Cloud-Based Deployment:
➮ The system provides centralized data storage, offering easy access to historical records for reporting and analysis.
➮ Cloud-based deployment ensures accessibility and security for all users, regardless of their physical location, promoting collaboration and remote work capabilities.
Key Benefits
⦿ 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
