eInfotree Excel Module

eInfotree Excel Desktop

Spreadsheets are commonly used in support of critical GxP applications. Examples of these include:

  • Clinical trials
  • Testing of raw materials, in-process testing, finished goods testing
  • Manufacturing logs
  • Assay testing
  • Training records
  • Records required by predicate rules (GCP, GMP, GLP)

Studies show that spreadsheets are highly prone to errors due to their easy availability and ease of use. Spreadsheet errors, in a GxP environment, can lead to serious consequences including improper release of a batch, erroneous clinical trial results and such. Simply put, spreadsheets used in support of predicate rules must be 21 CFR Part 11 compliant to comply with FDA regulations.

  • Store and use spreadsheets from a SharePoint Library
  • Store all audit trails, configurations and settings into an instance of SQL DB for automated backup, diverse reporting capability and added security.
  • No change in the user experience - spreadsheets can still be opened the way they were by simply double-clicking the file name.
  • No need to move the spreadsheets to a different location.
  • Simple and effective remediation of Excel Spreadsheets for 21 CFR Part 11 Compliance.
  • Save time and money by eliminating the need to migrate to a new system.
  • Quick and easy installation of software.
  • Automated and structured process provides confidence in spreadsheet controls and process integrity to aid in attestation.
  • A dedicated server is not required.
  • Easy to configure, use and maintain.
  • Reduced validation effort using an available validation package.

Audit Trail Audit Trail

  • Tracks both user and administrator actions
  • Records date, time, user ID, full user name, cell location, action type, old value, and new value
  • Configurable reason field
  • Fully secure and protected
  • Audit trail of user logins, logouts, and invalid attempts

Electronic-Signatures

  • Includes the user id and printed name of signer, the date and time the signature was executed, and meaning associated with the signature
  • Meanings of e-signatures are configurable
  • Signature not performed during a single, continuous period of system access requires all e-signature components

Security

  • Allows configuration of users and passwords
  • Enforces minimum length and composition of passwords to ensure security and integrity
  • Password Aging - forces new password after a configurable period
  • Transaction safeguards include account lockout after configurable number of retries
  • Loss management procedures to electronically deauthorize passwords temporarily, and require a new password after reset

Installation:

  • If assistance is required for product installation, this can be provided remotely over the Internet using WebEx.

Training:

  • CIMINFO can provide product training to users and trainers. Training can be conducted onsite or offsite using the Internet.

File Conversion:

  • Excel files can be converted into 21 CFR Part 11 compliant files with the click of a few mouse buttons. No support is normally required for file conversion.

Validation Package:

  • A validation package is available as an option for speedy implementation and reduced validation costs.

Validation Services:

  • CIMINFO can provide onsite or offsite validation resources and assistance as required.

Maintenance Support:

  • Maintenance support is available at a nominal cost and includes both remote technical support and product upgrades.