eCADinfo

eCADinfo – Engineering Data Management System

Developed specifically for the life sciences industry, eCADinfo is a 21 CFR Part 11 compliant engineering data management system designed to reduce costs and improve efficiency, productivity and compliance in FDA-regulated environments.

eCADinfo stores engineering data in a wide variety of formats that include engineering drawings, equipment/system specification databases, web links to supplier sites, spreadsheets containing device parameter data, procedures, manuals, and shop sketches. The system allows you to organize this data in a structured hierarchy of meaningful information that best meets your existing business processes. The rich graphical user interface provides a wealth of information at a glance for ease of system maintenance and control.

Engineering data management features include version control, collaboration, change management, standardization and a 21 CFR 11 compliant Excel spreadsheet environment. AutoCAD drawing management features include file comparisons, automatic drawing data extraction, redlining, search, reference file capabilities, and configurable workflows for drawing approvals.

  • Automate engineering data management for improved efficiency, productivity and compliance.
  • Access all engineering data at a glance including engineering drawings, equipment/system specification databases, web links to supplier sites, spreadsheets containing device parameter data, procedures, manuals, and shop sketches.
  • Manage AutoCAD drawings using a secure and controlled File Vault with Version Control and configurable Version Labeling. Full AutoCAD integration assures minimal impact on existing processes.
  • Compare drawings using AutoCAD Drawing Comparison, Image Comparison and Data Comparison tools. Compare changes to drawing blocks, layers and attributes between any two drawing versions.
  • Improve existing processes using automated tools such as drawing data extraction, redlining, search, display, print and reference file capabilities.
  • Add 21 CFR Part 11 controls to existing Excel spreadsheets used to store engineering parameters.
  • Improve teamwork with Collaboration and Change Management features.
  • Organize data in a configurable hierarchy of meaningful information that meets your existing business processes.
  • Apply configurable workflows for electronic review and approval of drawings.
  • Comply with 21 CFR Part 11 and GxP requirements for data security, control and accountability.
  • Reduce validation costs using an available validation package.

Drawing Display & Print Options

  • Preview drawings directly in eCADinfo
  • Multiple Viewing and Zoom options
  • Print drawings directly from eCADinfo
  • View drawing attributes, blocks and layer information
  • View files in native application if desired

Red Line Drawings

  • Redline drawings and save redlined versions. Redlined versions are archived and saved in the File Vault for record keeping.

Extraction of Drawing Data

  • Extract AutoCAD drawing data such as blocks, layers and attributes into eCADinfo database tables, allowing eCADinfo search, querying and reporting tools to be used on this data. Create a searchable index of drawings to locate drawings from title block information using keywords such as drawing titles, author, drawing type and equipment/system.

Referenced Drawings (X-Ref)

  • Automatic detection of referenced drawings with options for automatic check in and check out for all referenced drawings.
  • Ability to extract block, layer and attribute drawing information from referenced drawings in addition to the main drawing.

Workflow and Electronic Approvals

  • Design serial and parallel workflows using a drag and drop graphical Workflow Designer. Route drawings for electronic review and approvals with task escalation, drag and drop task delegation, notification and reporting options.

Notifications

  • Create notifications to selected users and groups based on configurable time periods, data objects and events.

Search

  • Perform full text search on Autocad drawings and other files stored in the File Vault.
  • Run keyword searches and ad hoc queries on drawing information such as blocks, attributes and layers using arithmetical and logical operators.

Export

  • Export drawing data such as blocks, layers and attributes to multiple formats such as Excel, CSV and XML.

Engineering Data Types

  • Supports a wide variety of engineering data types including version-controlled files, non-version controlled files, data bases, folders and web links.

Configurable Organization of Data

  • Organize data in a user configurable hierarchy that is most meaningful to you and meets your existing business processes.

Database Management

  • Create fully configurable databases to store instrument, equipment or system specifications. Create Preferred Lists of standard parts for reduced data entry and standardization.

File Vault

  • Engineering drawings and other files are stored in the system’s secure File Vault with Version Control, Configurable Version Numbering and Check In/Check Out features. Assign automatic version label templates based on folders/drawing types. Archive all previous versions of drawings and prevent modifications to the same file by more than one user.

Change Management

Relationships:

  • Visualize object relationships to predict the impact of engineering changes. Relate engineering drawings, procedures and equipment/instrument specifications to visualize the impact of change in one object to all other objects.

Maintenance/Change Logs:

  • Create any number of maintenance/change logs. Create one change log for files and another for specification data.

Standardization – The Basis For Quality

  • Create standardized engineering templates. Comprised of a hierarchical collection of databases, files and web links, templates can represent equipment/system types such as an autoclave. Templates allow ease of data entry, user training, data access and change management.

Collaboration

Securely share the engineering database repository between various engineering groups and external suppliers within a 21 CFR Part 11 compliant data architecture.

Discussion Groups:

  • Create threaded discussion groups organized by topic.

Notes:

  • Attach comments to engineering data objects using free text notes. Pass on instructions and relevant information between shifts and operating personnel.

Search

Keyword Search:

  • Search Database Records, Maintenance/Change Logs, Notes and Discussions using keywords.

Query Builder:

  • Run ad hoc queries on database objects and audit trail/e-signature logs using arithmetical and logical operators. Filter information based on Action, Object, User Name and Date Interval.

Full text Search:

  • Perform a full text search of all files in the File Vault.

Application Interfaces

  • Import/Export data from popular applications such as Microsoft Excel. Integrate with existing systems such as Computerized Maintenance Management Systems (CMMS), ERP, MES, and LIMS.

Installation

  • CSI offers installation services to install the software. Installation services can ensure proper system installation and operation in your computing environment during initial system start-up and implementation.

Data Migration

  • CSI offers data migration services to migrate data from your legacy systems and applications to eInfotree.
  • Recognizing that data migration is a critical component in the validation of any computer system, CSI offers services for preparation and execution of Data Migration Protocols to accompany the data migration effort.

Product Configuration

  • CSI offers Product Configuration services to configure eInfotree to your specific requirements and applications.
  • CSI’s product experts can help you optimize your implementation of eInfotree and derive a maximum return on investment based on a keen understanding of business processes, industry best practices and product knowledge.

System Integration

  • System integration services include an analysis of existing business systems and applications, an understanding of customer’s business needs, and designing and executing a system integration plan to integrate eInfotree with existing applications to optimize the eInfotree implementation and maximize return on investment.
  • These services also include technical analysis to identify validation issues and preparing validation plans, procedures and protocols to validate the integration effort.

Validation

  • CSI offers a validation package that includes Functional Specifications and Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols. CSI products are rigorously tested and validated internally following an ISO 9001 certified and FDA-recommended practices and procedures based on using a Software Development Life Cycle (SDLC) approach.

Training

  • CSI offers training services geared towards eInfotree users, administrators, and “train-the-trainer” services.
  • Training can be scheduled onsite or offsite.

Product Maintenance and Support

  • CSI product support and technical services are just a phone call away. CSI standard support services include technical support via phone, email or online support tools, as well as product upgrades and new versions. Premium 24 x 7 support services are also available.

Electronic Records and Audit Trail

User Audit Trail:

  • Stores all user actions such as drawing add, view, edit, delete, check-in, check-out, edit discussions, and edit notes in an audit trail with timestamp, user name, user ID, action performed, old value, new value and reason fields as applicable.

Drawing Audit Trail:

  • Stores standard, block, and Layers attributes, and track any changes to drawings or markups. Compare any two drawing versions graphically.

Database Records Audit Trail:

  • Stores all record versions and highlights changes between any two record versions since creation.

Administrator Audit Trail:

  • Stores all administrator actions such as version label template assignment, e-signature configurations, reason field assignments, user management, and user privileges.

Audit Trail Display:

  • View the audit trail at any hierarchical level with a single click. Group the audit trail by action, user, date or any other field. Query the audit trail using arithmetical or logical operators.

Configurable Reason Fields:

  • Set to optional or required based on object/action combination.

Electronic Signatures

E-signature Templates:

  • Create e-signature templates defining the engineering data operations that require e-signatures.

Configurable E-Signature Assignment:

  • Different templates can be applied to different engineering data/drawing object types (eg. GMP vs. non-GMP) for unlimited flexibility and control. E-Signatures can be inserted into engineering data Forms.

E-Signature Roles:

  • Define meanings (roles) for e-signatures and restrict user authority for e-signatures to specific roles.

Security

Protection of Data:

  • Engineering data is stored securely in the system database. Drawing and other files are stored in the secure File Vault with Version Control, Configurable Version Numbering and Check In/Check Out features. Vault can only be accessed with a valid user and password combination. Windows authentication can be enabled to use existing Windows credentials.

Security Templates:

  • Create security templates defining access levels for engineering data operations. Control user privileges such as Add, View, Edit, Checkin, Checkout, Delete and None (no access).

Configurable Security Templates Assignment:

  • Different security templates can be applied to different engineering data/drawing object types for each user group for unprecedented flexibility and control.

Password Management

Password Aging:

  • Force a new password after a configurable amount of time.

Password Lockouts:

  • Lockout the account after a configurable number of retries.

Session Timeouts:

  • Lockout the application after a configurable session time-out period.

Password Masking:

  • Force passwords to match a password mask.