21 CFR Part 11 Compliance for Spreadsheets

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

  • 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

Overcoming 4 Challenges to the Use of GxP Compliant Spreadsheets

Today, spreadsheets are commonly used throughout the biopharmaceutical, pharmaceutical and other FDA-regulated industries. Spreadsheets are considered systems and when they impact data that affects product identity, strength, purity and safety, they must be validated and controlled. The purpose of this White Paper is to review the solution to four (4) common challenges when using spreadsheets to meet GxP quality requirements.