Data Integrity Challenges in Paper Based Validation

The FDA and European regulators issued recently guidance documents that define the requirements for data integrity for GMP records. Validation documents are considered GMP records and are subject to these data integrity requirements.Traditional validation relies in paper-based records to manage the lifecycle of computer systems, equipment, and processes. Unfortunately, the data integrity of paper-based validation processes is highly dependent in procedure controls and the honesty of individuals creating, approving and executing validation documents. Validation paper-based documents and records are very often misplaced and lost in document archives or during the review and approval cycle.

Paperless validation technology enables full compliance with data integrity regulatory expectations by eliminating the challenges found in paper-based validation processes.

Paperless validation technology fully automates the lifecycle process for cleaning, process, computer and equipment validation.

Paperless validation provides the following advantages

• Eliminates documentation errors
• Eliminates data transcription error
• Eliminates paper-based records
• Eliminates the cost of validation document archival
• Eliminates misplacing and losing validation documents

Paperless validation enables full compliance with current data integrity requirements from the FDA and European regulators.