DocsExecutive™  Dossier-Mgmt© SPL eTraining
 
 
  DocsExecutive™ is the one of most feature packed Document and Process Management systems available in the market today.  
  It helps the Organization improve its departmental efficiency by way of Process/Procedure automation and implementing  
  paperless office.  
   
  Documents  
 
  It is a web-based Electronic Document Management System that automates and seamlessly manages your document control
 
  process.  
 
  It manages the entire document lifecycle process and gives you the tools to securely manage a wide range of business
 
    documents, including those related to regulated environments.

Addressing all the documentation requirements for industries like Pharmaceuticals, Biological, Veterinary, Chemical
    and Medical Device manufactures.  
  It ensures compliance with international GAMP guidelines.  
  It helps in maintaining compliance with FDA 21 CFR Part 11, Annex 11 and other international standards with electronic
 
    signatures.  
  It is designed specifically for management of SOPs, Deviations, Change requests, Specifications and many others GMP  
    documents with pre-approval flow built in.  
  Manages at ease lifecycle of templates/formats for BMR/BPR, SOP, Change Request, Deviation and any other documents.  
    These formats have different document and version numbers.  
  Role-based document authoring and access management for multi-user electronic document authoring and publishing.  
  Elaborate review and approve process with facility to obsolete documents.  
  It is available for installation as an independent software product.
 
 
  Search Features  
 
  Documents can be searched by its Title, Effective dates, Expiry dates etc.  
  Author can define special keywords for each document for aiding search facility.  
 
More than 10 Meta fields are provided for document search.

 
 
  General Features  
 
  DocsExecutive™ provides two methods of document creation. One method where the user has to get pre-approval process
 
    before any SOP or HR policies are changed. The other method allows access to the author for editing without the pre-  
    approval process. This method will be typically required for specific non GMP document types like work requisition, inter  
    office memo etc.  
  Electronic Signature can be implemented in this solution. The definition of electronic signature will be as per the USFDA  
    guidelines.  
  Control access to documents and data at any or all of the five different security levels – Location, Dept, Project types,     
    Document Type and Document Version.  
  Permissions based security mechanism, with a basic and advanced permission list.  
  Control security and password policies.  
  In-process Document Tracking by Controller and Author  
  Auto Publishing of documents.  
  Auto Expiry of documents.  
  Auto task reminder for all.  
 
  Database  
 
  Supports MS-SQL 2000, 2005 and Oracle 8i.  

 

      Features of  Enterprise edition  
 
      Elaborate configuration management at document type level.
      Dynamic Labeling provision.
      Choice of Converting into PDF/HTML during publishing.
      Template definition license based.
      Sequencing for document review and approve.
      Advanced document access level definition.
      Store unlimited number of documents in each database.
      Event auditing (Log information about user actions).
      Document Full Text Search if Windows based file server.
      Document check-in/checkout.
      Pre-approval process for document change.
      Document content change tracking across versions.
      Department-wise Controller definition.
      Extensive confirmation option for every document type.
      Control printing of critical GMP documents like BMR/BPR.
      Linux based file storage server.
 
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