21 CFR Part 11 Compliance.com

Document Control System

Company Info. Center Support Contacts OEM


   

 

 


The smooth, efficient flow of business information is the lifeblood of a successful company. Ranging from SOPs, Study/Protocol documents, engineering drawings and marketing collateral to invoices, contracts, and insurance claims – business content needs to move effectively among the right individuals at the right time. In most organizations, however, content silos and cumbersome paper-intensive business processes prevent companies from achieving greater efficiency in the creation, management, and delivery of critical business documents.

DocMan enables organizations to:

  • Gain control and visibility – create a single access point to manage content, projects, and processes; manage and map governance processes to an internal control framework; and increase accuracy and quality
  • Create efficiency and lower the operational cost of compliance – automate manual steps and streamline processes; reduce the cost of archiving and maintaining content and records; and provide workplace collaboration to improve decision-making
  • Maintain a Master List –
    A master list of controlled documents is not only a Quality System Requirement, but also a necessity for managing your inventory of critical documents and data.
  • Document Approval Process –
    The personnel approving a document revision will often have comments that become an important part of the documentation on the document itself. The approval process often yields important information about the process covered by the document.
  • Identify Change History –
    As documents evolve over time, it is important to know the difference between revisions. A change to a method or manufacturing procedure ultimately changes your deliverable product.
  • Archive Obsolete Documents –
    Consider the problems created through the use of outdated SOP or assembly instructions at one of your manufacturing stations. It is imperative that all personnel are reading the same script.
  • Increase Productivity –
    In organizations where technology has proliferated without controls, many different software platforms and versions of an application may exist, leading to uncontrolled versions of  data files and data integrity problems. Using DocMan to manage these applications can help address and stop these issues and thereby increase productivity.

Five major business drivers make effective document management a key requirement for today's businesses:

  • Accelerating paper-based business processes – As technology speeds the pace of business, companies can no longer afford the delays associated with routing paper documents through critical processing and approval stages.
  • Compliance requirements – With Sarbanes-Oxley, HIPAA, and new regulations from the SEC, every (publicly traded) company must comply with a mountain of new requirements in addition to older regulations surrounding the creation and manufacture of industry-specific products and services.
  • Content enablement of enterprise applications – True automation of business processes requires enabling scientific enterprise applications such as LIMS (laboratory information management system) IDS (instrument data system) to integrate unstructured content into transactional workflows. Leveraging DocMan as a single source for content across these applications enables customers to create virtual folders that deliver a 360-degree view of all content associated within a study/protocol or business transaction.
  • Enterprise publishing – In today's environment of needing to do more with less, it's increasingly important to find ways to leverage, reuse, and re-purpose enterprise information when publishing across a variety of channels.
  • Standardization and optimization of content infrastructure – In order to lower TCO (total cost of ownership) and reduce complexity, many organizations are seeking to consolidate the management of unstructured content types such as documents, scanned images, CAD drawings, Web files, and business records on a single platform managed through a single product.
Excelฎ and Wordฎ are trademarks of Microsoft.