Life Sciences Solutions - DMS

FineDocsTM

Success Story

  • Industry

    Life Sciences

  • Solution

    FineDocs Enterprise Content Management (ECM) for R&D, Quality and Manufacturing

  • Benefit
    • An Institutionalized Platform with enhanced Quality, Compliance and Performance
    • Enhanced Collaboration with Centralized, Scalable, Single Source of Truth for Enterprise Content
    • Streamlined Regulatory Compliance with Validation and Control to appropriate
    • Multi-level Content Security and Integrity
    • 90-100% reduction in time required to access and view information
    • Reduced documents storage cost burden over 70-80% with a fully controlled disaster-proof system
    • Enriching user experience with intuitive unified user interface
    • A less-paper office and a simplified path to paperless future
Read the Customer Story

Document
Management

Life sciences Industries require a solution which is flexible, scalable, easy to use and can give a best fitment to their needs. It should work as an integrated solution which can cater to core transaction Processing along with Document Management Solution.
The Challenge
Life Sciences Industries are facing mounting pressure to get rid of the paper for a number of reasons, such as reducing costs, decreasing errors, improving information accessibility and compliance with regulatory requirements and heeding the Federal Government’s directive to adopt electronic records system with electronic signatures.
Some of the Key Challenges are:
  • Life Sciences industry is swimming in paper, as more then 80 percent of all information exists on paper for manual approval with penned signature. The documents like R&D Reports, Training materials, Pharma Product Manuals, Sales & Purchase orders are generated from the ERP and stored in the record rooms either in the printed paper form or in electronic format, managed manually in the local drives or tape drives
  • Handling documents in diverse sources, huge challenge in synchronization and change control and version management failing to maintain integrity
  • Decentralized File Management leads to non-collaborative environment with increasing level of complexity with huge volume of records with duplication issues
  • High cost burden of storage and duplication as physical storage of documents and inefficient tracking leads to high storage cost
  • Physical record room is unprotected from disaster, may also lead to risk of unauthorized access and lost information
The Solution
Life Sciences content management solution effectively manages all kinds of structured and unstructured content i.e. QA documents, SOP, drug specifications and batch records, electronic logbooks and other records of R&D , Quality division, manufacturing unit and clinical testing partner in a centralized archive and seamlessly collaborate on documents to bring safe, high-quality drugs and medical devices to market faster and at a lower cost.
The solution platform includes:
  • A collaborative digital workspace for life sciences workforce with integrated solutions in the base framework of enterprise content management, leveraging a simplied information management in each phase of R&D, quality and manufacturing lifecycle of drugs, injectables and medical devices
  • Enterprise document search with quick and easy access to medical information and linking documents for cross-referencing e.g. R&D with manufacturing documentation, Quality documentations with Audit procedures etc.
  • Ensure FDA compliance for electronic records management and security standards in the content life cycle phases of creation, classification, retrieval and archival with a complete safeguard, quality controlled documentation with greater accuracy
  • Automated document distribution of regulation policies, procedures, training documents, quality guidelines using shared link maintaining single source of truth
  • FDA 21 CFR Part 11 compliance for electronic signatures, role based access control, audit trails and reporting
The Benefit
The Life Sciences industry is repositioning itself for continued success and FineDocs's flexibility and extensibility has proved beneficial to enterprises as it progresses its journey to optimize operational proficiency.
Some of the Key Benefits are:
  • An Institutionalized platform with disaster-proof, multi-level content security and integrity with highly efficient change control and versioning of life sciences documentation with greater efficiency and improved productivity
  • Increased transparency in collaborative working as managing documentation across divisions and units of R&D, quality and manufacturing becomes faster with improved operational performance eliminating redundant tasks
  • Instant access to information within seconds anytime, anywhere with a reduced downtime to approx. 80% with a greater control to manage, share and reuse information from a single, authoritative information source
  • Reduced physical storage and maintenance cost burden to 70-80% as life sciences can now manitain less physical pieces