Paperless validation is an electronic process of ensuring that equipment, software, spreadsheet, utilities, cleaning, and processes, including the series of tests in Life Science companies are compliant with FDA, EMA, and WHO.

What Is Paperless Validation?

Data Integrity

Data Integrity ensures that the data inserted in documents are attributable, legible, accurate and contemporaneous and original.

Traceability Matrix

Traceability matrix is a document that links GMP requirements with their tests over the validation lifecycle.

Time Spent Validating

The speed of validation projects by paperless methods, is to be allowed to do the validation from start to finish in just one software.

Agile Compliance

Reduce repetitive and mechanical activities, leaving the thinking activities like Risk Assessment and testing strategies for the validation specialist to decide.

Data integrity

Data Integrity in a validation project refers to ensure that the data inserted in those documents, such as 21 CFR Part11 test scripts are attributable, legible, contemporaneous, original, and accurate.

In case of some changes in data, the Validation Analyst should review all paper documents manually.

If you conduct your project using a paperless validation software, the chances of a break of GxP compliance are smaller.