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.
10 reasons to consider paperless validation software
- More compliance: decrease regulatory risks to businesses and data integrity.
- Faster time to market: with no validation, biopharma and medical device industries cannot register or produce their products.
- More efficient work: ‘right the first time;’ decreaq6se the time to compliance, make projects agile, and possess ‘a knowledge database’.
- Decrease validation costs: faster work, avoid paper work, no printers, no physical space to store documents, no documentation scanning.
- Remote work: healthier staff and quality of life, online management, connect teams between several countries.
- Easier validation status maintenance: decrease the time to keep validation status with constant update and periodic inspections.
- Easier audits: immediate availability of data.
- Standard documents: maintaining good documentation practices according to GMP guidelines, GAMP5®, for example.
- Easier management: immediate availability of data (online management)
- Sustainable: no use of paper, no printers, no cartridge disposal
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 one conducts their project using a paperless validation software, the chances of a break of GxP compliance are smaller.
The data inserted on the platform has integrity when using GO!FIVE®.
Traceability Matrix
Traceability matrix is a document that links GMP requirements with their tests over the validation lifecycle.
This deliverable ensures that all requirements defined for a system, software, and process validation are linked with their respective risk scenarios and tests.
In a traditional way, based on paper, the Analyst needs to link all requirements with their test protocol items manually.
With a paperless validation software, like GO!FIVE®, the traceability matrix is built in automatically, reducing time, and avoiding mistakes.
Time spent to validate
With all these points explained, one doesn’t have to think a lot to realize how expensive it gets when validation is paper-based.
With GO!FIVE® , a paperless validation software, the time to validate drops by 5 times!
Another advantage to enhance the speed of validation projects by paperless methods, is to be allowed to do the validation from start to finish in just one software.
Not like an EDMS (Electronic Document Management System), which is commonly used for validation projects. EDMS still needs paper documents management during test run phases.
Financial benefits
The digital possibility to carry out a validation project, in just one software, also translates to financial benefits for industry and laboratories in the Life Science market.
In addition, using a paperless validation software reduces your team efforts to finish the project, saving 65% of your validation costs!
Agile compliance that empowers your team!
GO!FIVE® is a balanced software platform. It reduces repetitive and mechanical activities, leaving the thinking activities like Risk Assessment and testing strategies for the validation specialist to decide.
It has a library, which is a compilation of all the knowledge acquired by FIVE in more than 1000 validation projects, anonymized and built into the database with pre-formatted information about each topic.
However, your validation specialist has power to decide if these items adhere with your process, your project, taking advantage of an enhanced, pre-existing expertise database, not starting from scratch with every new project, saving a lot of time, producing validations at least 5x faster.
The company shows the care with your professionals.
In this pandemic time that we are living in, a paperless validation software allows the analysts to do all sort of validation tasks remotely, and some of them 100% without the need of working on site.
That means more quality life and less risk of contamination by Covid-19.
Do you have validation projects and want to modernize the way you carry out it?
Get in touch with us and have a demo presentation of our paperless validation software.
Source:
FiveValidation