Paperless Validation For Validation Specialists

Paperless Validation For Validation Specialists

Paperless validation is the next step in your company’s growth. This is an essential element of 21 CFR Part 11, which allows you to maintain a paperless system with electronic documents, as long as they are properly secured.

However, many companies and validation professionals struggle to implement this kind of document management system successfully. Let’s look at what paperless validation is and why it can be effective for your company’s needs.

Traditional vs paperless validation

Traditionally, validation (e.g., equipment, computer systems, process) is performed by physically putting pen to paper and recording relevant data onto approved printed test documentation in accordance with cGMP and ALCOA+ principles.

This typically involves seeking wet-signature approvals throughout the entire process. These documents are then physically stored and archived for the required number of years before being disposed of.

A paperless validation system aims to replace, or at least simplify this process. All aspects of this new system, from document creation, review, execution, approval, and storage, are done electronically. Validation test executions are performed using software applications which allow real-time data to be recorded contemporaneously.

What is paperless validation?

Paperless validation is a process that replaces paper-based documentation with electronic documents. It's a method of electronic data capture and electronic document management. With paperless validation, you can use an automated workflow to track your quality system and ensure compliance in real time by leveraging the power and flexibility of technology.

By using paperless validation software for regulatory submissions, life science companies can eliminate the need for manual data entry into multiple systems or spreadsheets, which is both inefficient and error-prone when done manually. This approach also helps reduce costs associated with maintaining records by eliminating printing costs while improving accuracy through automation

Are you ready for the paperless validation of your company?

Paperless Validation will help you with the following:

  • You can ensure that all documents are stored in one place, making it easy to find and access them.
  • Electronic document management makes it easier to keep track of versions of documents and ensure that no one modifies a document without authorization.
  • It's easy for employees to share files with each other using electronic systems, which helps keep everyone on the same page when working on projects together.
  • You can protect your company's intellectual property by storing documents securely in an electronic system rather than storing paper copies in filing cabinets or on-site servers.

 Why should you consider electronic document management?

  • Reduce the risk of paper-based errors.
  • Reduce the risk of data loss.
  • Reduce the risk of compliance breaches.
  • Reduce the risk of regulatory fines.
  • Reduce the risk of business interruptions.

How to successfully implement paperless validation in your company?

To successfully implement paperless validation using electronic document management in your company, you need to be sure that the right people are involved. You should start with a pilot project and set up a data governance committee. Next, make sure you use the right tools for the job. If you’re setting up a training program, make sure it covers all areas of office functions so everyone knows how to use them.

Once these steps have been taken care of, it's time to get started on paperless workflow! To make sure this is done correctly and securely, it's important that you have appropriate security measures in place before going full speed ahead with any new systems or processes—this includes making sure there is enough IT support available if anything goes wrong with computers or servers at any point during implementation (or after).

Electronic Document Management and 21 CFR Part 11

Part 11 is a set of regulations for electronic records and signatures in the U.S., with Part 11 it is possible to establish that a document has been created, stored, and/or modified by a system in accordance with secure data management principles. It also allows you to prove that any signature associated with your record meets various technical requirements.

This can be useful for demonstrating compliance with standards such as 21 CFR Part 11 (a set of regulations governing electronic records) or other industry standards such as PCI DSS or ISO 27001/27002.

An effective electronic document management system helps you stick to regulatory demands.

An effective electronic document management system helps you stick to regulatory demands.

No matter what your company’s business, an electronic document management system can help reduce the risk of data integrity issues and system validation issues. This can also help in meeting regulatory requirements, as well as business requirements.


If you’re a validation specialist working in a life science company, it’s time to ditch the stacks of paper and start using electronic document management. This technology can help your company comply with regulatory demands and improve efficiency—and it doesn’t have to be expensive or difficult. With the right tools and support from experts, you can implement an effective solution in no time at all.

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