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.
- 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
- 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
- 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