AmpleLogic Document Management Systems are set to transform documentation processes across the pharmaceutical, biotech, and other regulated industries. Manual documentation often leads to version control issues, misplaced files, and compliance risks—challenges that can result in costly delays and regulatory scrutiny. Our solution mitigates these risks with robust features designed to streamline your workflow.
With robust features such as version control, collaborative documentation, automated workflows, and comprehensive archival systems, we enable organizations to enhance operations while ensuring strict regulatory compliance, including adherence to standards like 21 CFR Part 11.
Manage documentation lifecycle from creation to obsoletion
Protects sensitive data from unauthorized access and breaches by implementing encryption
Enables quick side-by-side comparisons to highlight differences, ensuring accuracy and consistency
Future-ready with ML and AI for intelligent task routing and automatic reviews
The Pharma, CDMO, Biotech, and CRO industries face critical challenges with manual document management systems, including time-consuming processes, high risks of document loss, and version control failures. These inefficiencies also extend to poor inter-department collaboration, lack of auto alerts for revision deadlines, and training difficulties due to disjointed systems. Effective document maintenance in the pharmaceutical industry is vital to addressing these issues and ensuring streamlined operations.
AmpleLogic’s Electronic Document Management System (eDMS) is a comprehensive solution that resolves these issues by automating document-related tasks, ensuring seamless collaboration, and reducing manual errors. Key features include real-time tracking, automatic reminders, and secure digital storage with backup and recovery protocols. Additionally, our system integrates with Learning Management Systems to automatically trigger training needs upon document updates, ensuring compliance with evolving regulatory standards. Further enhancing its value, AmpleLogic eDMS complies with global regulatory standards such as TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH, guaranteeing that your operations align with the most stringent compliance requirements worldwide.
In a dynamic industry where time is paramount, choose AmpleLogic Compliance Document Management Software for unparalleled efficiency. Our system enhances efficiency, guarantees accuracy and integrates with standard operating procedure format for proper process maintenance and regulatory compliance.
Automatically updates SOPs via change control workflows, ensuring no information is missed during updates
A dedicated flow for handling child documents like annexures and formats linked with parent SOPs.
Implement strict access protocols to ensure that only authorized personnel can view, modify, or share documents, bolstering data protection
Facilitate parallel reviews and streamlined collaboration across departments, ensuring everyone is aligned and informed
Experience the power of
AmpleLogic DMS with these key features
Manage all documentation—including SOPs, STPs, protocols, BMRs, BPRs, and quality manuals—from creation to obsoletion with ease.
Utilize intelligent tagging to categorize digital files, enhancing organization and retrieval efficiency.
Generate accurate master, reference, controlled, uncontrolled, training, and draft copies using standardized templates to maintain consistency.
Maintain comprehensive documentation of audit trails across departments, ensuring transparency and accountability.
Displays pending tasks, reminders, and notifications for users to ensure no important action is missed.
Access control based on user roles, ensuring only authorized personnel can view or edit certain documents or access archived data.
Create documents following standardized templates, with customizable Document Number Formats (DNF), control selections, header controls, and signatory controls for consistency and compliance.
Minimize the risks of overwriting and duplication through meticulous document comparison and revision control, with authorized tracking to ensure accuracy.
Systematically manage documents that are no longer active but are retained for reference and audit purposes, ensuring compliance and accessibility.
Generate comprehensive reports, complete with notifications regarding effective dates, upcoming revisions, and documentation needs.
Specific workflow for document print requests, including tracking the number of copies, purpose, and reprints with approval processes in place.
Apply visible watermarks—text, graphics, or barcodes—to documents, indicating their status and preventing unauthorized duplication.
Experience swift document retrieval through predefined mechanisms, automating processes that traditionally required manual intervention.
Track pending tasks to boost productivity and ensure compliance with real-time tracking, email notifications, reminders, and escalation alerts.
Facilitate seamless cooperation between departments to enhance document handling and verification processes.
Seamlessly integrate with Learning Management Systems, ensuring that all personnel are up-to-date with revised regulations and processes.
Easily integrate with external systems and AmpleLogic’s QMS and Learning Management Software, streamlining data collection and management.
Our integrated SOPs ensure streamlined processes that align with regulatory requirements, promoting compliance across the board.
Quickly locate and access specific documents, empowering users to find necessary information without delay.
Tracks the issuance of BMR, BPR copies, and other documents along with their prints, ensuring proper record-keeping.
Our intelligent automation routes key documents, includingSOPs, to right personnel, ensuring timely access to the latest versions.
Industry-Specific Software for Enhanced Quality and Compliance
Maintaining strict quality standards, efficient processes, and compliance with regulatory requirements is paramount in the highly regulated and complex pharmaceutical industry. Document management plays a
In the pharmaceutical industry, data integrity is paramount to ensuring the safety, efficacy, and quality of medications. The term “data integrity” refers to the accuracy,
Incorporating new-age technology in Lifesciences: With the new digital innovations happening every day, every industrial sector, including pharma and life sciences companies, has witnessed remarkable
AmpleLogic DMS ensures document security through role-based access, secure digital storage, and backup procedures.
Yes, AmpleLogic DMS seamlessly integrates with Quality Management Systems (QMS), Learning Management Systems (LMS), and more.
ML/AI integration brings advanced capabilities like automatic CFT detection, intelligent task routing, and automatic reviews.
AmpleLogic Compliance Document Management Software automates version control, ensuring access to the latest document versions and preventing regulatory issues.
AmpleLogic DMS ensures efficient document tracking, print control, and retrieval, streamlining the entire document issuance process.
Our solutions are available and accessible globally, ensuring businesses worldwide can benefit from our expertise in quality management.
We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage:
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