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 to the regulatory bodies such as FDA, EMA, and WHO.
All steps of the validation process are registered in digital documents, or items, rather than on paper, as in the classic computer system validation FDA format.
By not using a single sheet of paper, the paperless validation presents many benefits to companies, professionals, and the environment. One of them is to convert a most common, system validation such as ERP (Enterprise Resource Planning), which usually uses almost 2,500 sheets of paper, converting it into ‘zero paper’.
That means not only paper sheets increase demand, but printer cartridges, folders to organize these documents, space to allocate these folders, and valuable trees to make the paper; not to mention the energy and water that are used in paper production.
1.) More compliance: decrease regulatory risks to businesses and data integrity.
2.) Faster time to market: with no validation, biopharma and medical device industries cannot register or produce their products.
3.) More efficient work: ‘right the first time;’ decrease the time to compliance, make projects agile, and possess ‘a knowledge database’.
4.) Decrease validation costs: faster work, avoid paper work, no printers, no physical space to store documents, no documentation scanning.
5.) Remote work: healthier staff and quality of life, online management, connect teams between several countries.
6.) Easier validation status maintenance: decrease the time to keep validation status with constant update and periodic inspections.
7.) Easier audits: immediate availability of data.
8.) Standard documents: maintaining good documentation practices according to GMP guidelines, GAMP5, for example.
9.) Easier management: immediate availability of data (online management)
10.) Sustainable: no use of paper, no printers, no cartridge disposal