Document management system
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The document discusses the need for an automated document management system in the pharmaceutical industry. It outlines challenges with manual document management including lack of control, complex retrieval and archiving. An automated system would facilitate collaboration, improve regulatory compliance, and provide features like version control, workflows, and role-based access to address these issues. The solution presented includes templates, numbering, searching, and integrations with quality and manufacturing systems.
Document management system
- 2. PROBLEM STATEMENT Pharmaceuticals industries are in a highly regulated environment and require effective document management process. With increasing amount of documents pharmaceutical companies deal with below issues: • Little control on the accessibility of the document • Tedious process in case of obtaining approval and signatures • Retrieving information requires manual search • Indexing and archiving is complex, costly and time-consuming • Larger documents restrict mobility • Tracking down any document activity is difficult • Short shelf life and difficult to recover • Non uniform date and signature entry • Illegible writing Manual Document Management Process
- 3. BENEFITS OF AUTOMATING DOCUMENT MANAGEMENT PROCESS Facilitated Collaboration Improve access to Records & Information Reliable Backups & Reduce Queue Time Improved Regulatory Compliance Enhanced Document Security & Control Easier Retrieval & Search
- 4. CONNECTING DOCUMENTS AND SOLUTION FEATURES AMLPELOGIC FEATURES TYPES OF DOCUMENTS Specification & STPs / GTPs SOP Protocols Batch Master Copies Validation Master Plan Site Master Files Apex Documents Forms / Annexure Analytical Sheets Raw Data Sheets APQR DPRs Document Template Number Format Version Control Document Comparison Search and Retrieval Document Collaboration Workflows Watermark & Overlays Print Controls Document Issuance DOCUMENT MANAGEMENT SYSTEM Document Archival Role Based Access
- 5. DETAILED DOCUMENT MANAGEMENT SYSTEM FEATURES Document Format Create & define header, footer, cover & approval page etc. Document Template Define and upload uniform template for different document types Number Format System generated document number based on document type, plant and department Document Comparison View entire document revision and version tree to compare document content Print Controls Print or download different document copies i.e., controlled, training, draft etc. Search and Retrieval Advanced search for getting access to documents immediately Reports & Dashboards Custom reports to provide real time status of document activities and updates Version Control Records version and revision of document created or updated STANDARD FEATURES ADDITIONAL FEATURES CUSTOM COMPONENTS Workflows Manage and define workflow for routing of documents i.e., for review and approval Role-based Access Manage access rights for documents based on users roles & responsibilities Document Archival Move documents to Archival Library after a set period of time Document Collaboration Share document with colleagues for collaboration and review Document Issuance Records are maintained for issuing any document with sign & date File Formats Support multiple file formats including word, excel, pdf, image etc. Watermark & Overlays Define and print watermark for different document copies Document Tagging Attach multiple supporting documents for document types i.e., Annexure, Form Integration Integrate with Active Directory, ERP and other Quality Operation Systems Document Security Configurable security settings to control document at different levels i.e., department, site etc. Types of Document Categorize document based on GMP & non-GMP etc.
- 6. REGULATORY COMPLIANCE FEATURES AmpleLogic solutions are compliant to meet the requirements of regulatory bodies like FDA’s 21 CFR Part 11, EU Annex, MHRA etc. Audit Trial Digital / Electronic Signature Access Authentication Record Audit Copies of Records View History
- 7. Solution Integration for coherent business processes Document Management System in the pharmaceutical industry cannot be a ‘stand alone’ independent software, it has to seamlessly integrated with the quality management system, manufacturing systems, Electronic batch manufacturing records and various other electronic documents that are generated in the manufacturing process. QUALITY SYSTEMS MANUFACTURING SYSTEMS
- 8. 2010 Operations Started in Hyderabad India 2012 First GMP Implementation of Audit Module using LOW CODE PLATFORM 2014 ISO 9001-2015 Certification Associated with 10 leading pharma companies for DMS and QMS implementations Signed up with 7 leading Pharma Companies2015 2016 Recognized by CIO review magazine and Silicon India for unique delivery models Launched QC automation modules and LMS solution 2017 Associated with 25 US FDA/MHRA/WHO approved Plants 2018 Finalist in CPHI Worldwide Awards, Entry into Egypt and UAE Markets Foundation to develop new modules like APQR, Product Recall, ANDA & DMF tracker Started working on draft Quality Metrics guidelines by USFDA 2019 US Market entry, Appreciated by 7 customers during audit on our Paperless automation 120 Young Engineers, 10,000 Sq. feet offices and 3 channel partners Road map to add more flexibility to eBMR/MES, eLogs About AmpleLogic Trusted by 35+ Pharma & 20 Non Pharma Companies across Globe
- 9. Pharmaceutical Business Process - Ready to Use Modules 16 6 6 7 17 1 2 No of Implementations Yet to Launch
- 10. Our Customers Pharma and Biotech Non Pharma
- 11. Any Queries? Please Contact us: info@amplelogic.com Visit Us : https://amplelogic.com/ Thank You