Electronic Signatures: New Protocol of Verification of Quality Records and Documents

As organizations are going paperless with the adoption of electronic document management systems and record-keeping, the next natural evolution for them is electronic signatures. The norm of digital signatures has offered companies a secure way to verify the authenticity of the electronic records and critical documents.

Let’s start with the fundamentals by going through the definition of the term “Electronic Signatures” and how is it different from the term digital signatures, which people often find confusing.

Digital Signature

A digital signature is often referred to as a mathematical scheme to verify the authenticity of the digital documentation. A digital signature is considered valid only when its prerequisites are satisfied. It makes recipient to strongly believe that the document received is created by the authenticated person and there have been no alterations done in transition.

Digital signatures belong to the cryptographic protocol suites as a standard element. They are commonly used for the purpose of software distribution, contract management, financial transactions, and in many other instances where forgery or tampering is not affordable.

Electronic Signatures

The implementation of the electronic signatures is only attainable with the help of digital signatures. It basically refers to the electronic data that has the intent of a signature. However, it is not necessary that all the electronic signatures will use digital signatures. With the time, electronic signatures have gained a legal significance in many of the countries including the United States, Uruguay, Switzerland, Algeria, Mexico, Saudi Arabia, Turkey, India, Brazil, Indonesia, and the countries of the European Union.

Electronic signature proved to be of great help in quality management systems wherein the approvals and reviews are required from geographically dispersed teams. Now, they can sign the document electronically from anywhere anytime without having to be physically present. In other words, validation and verification will no more be a reason for the delay in quality management processes since it’s easy, simple, and quick with the electronic signatures.

Need for Electronic Signatures

Stringent regulations and compliance requirements defined by different global regulatory authorities require highly regulated industries like pharmaceuticals, life sciences, automotive to have a proper process of validating and demonstrating compliance based on the prescribed information systems or applications that can support the core business processes. Such a demonstration of fitment is commonly referred to as Computer Systems Validation (CSV).

On the other hand, paper-based validation usually consumes an average of 300 pages of printed script copies. The scanning of the scripts with the manual authentication can make the project cost higher. Moreover, there are incremental costs of maintaining such critical documents in the same physical state for a specified period, which requires you to arrange sustainable storage through weather-resistant cabinets. It will not be wrong to say that even a simple validation project can consume a large amount of paper than you can imagine due to the mandatory documentation and wet approvals it carries along.

Explained: Functions of Electronic Signature

Electronic Signatures serve a variety of functions. Some of them are mentioned below:

• It works as a smart substitute for traditional handwritten signatures. An electronic signature serves the purpose of the handwritten signature without much difference. In fact, electronic signatures are also fulfilling legal requirements.
• It keeps the integrity factor intact. Electronic signatures instill a “sealing effect” for the new digital documentation process. Any documents signed electronically need not to be put on hold or printed for manual signatures.
• It ensures authenticity. Using an electronic signature, you tend to send assurance that the person who has signed the document can be identified – naturally and legally.
• It gives a sense of authorization as well. You can manage all the rights and authorities through a duly signed and authorized certificate, which can be assigned to the person.

Even U.S. Federal law on certification services has defined two types of signatures considering the types and use of digital certificates:

• Advanced Electronic Signature: It is the one created for integrity protection and Signatory identification. It can be used in general as well as for the legal formalities. Most importantly, it is only assigned to the “owner.”
• Machine or Server Signature: It is suitable when “Owner” is not available to sign the documents all the time. The machine or server can also be the owner. It is not equivalent to a handwritten signature. You can use these to sign the digital documents, especially where legal formalities are not required.

What is the Qualified Electronic Signature?

A qualified electronic signature is the one that fulfills all the required regulations. It is basically referred to as an advanced electronic signature that is issued to a specific person. It is developed through a secure signature creation device and based on a valid certificate of qualification. And, the certificate must be from a recognized provider of certification services. For this, the “owner” of the signature is always a natural person.

Advantages of Electronic Signature (eSignature) Enabled Quality Management Systems (QMS)

There are several benefits of using eSignatures enabled quality management systems to validate and verify your quality processes and workflows:

• Ease in workflow configuration: Electronic form of signatures enable users to set different levels of authentication in their workflows. It ensures scalability and flexibility to configure the workflows that they find easy to work with.
• Enhanced Support for Bulk Permissions/Approvals: eSignatures support bulk approval for the different quality management processes and design elements that need to be duly reviewed and approved by signatures from a regulatory point of view.
• Supports End-to-end Test Management Activities: The eSignatures also support end-to-end test management processes like defining the requirements, preparing the test plan, assigning the test lab, and creating defects modules for compliance.
• Generation of Validation Summary Reports in Downloadable Formats: This is one of the out-of-the-box features of eSignature enabled quality management systems that enable organizations to generate downloadable summary reports regarding validation in secure formats like PDF or HTML.
• Audit trails: eSignature enabled QMS helps organizations to produce the detailed audit trails required for stakeholders and regulatory organizations.
• Applicability in Multiple Industries: QMS with eSignature capability is suitable for all the highly regulated industries, such as healthcare, food and beverages, automotive, life sciences, etc., where the use of eSignatures is mandatory.

Additionally, you will experience faster implementation time, reduction in the investments and running costs, ubiquitous presence (no dependency on geographical locations), easy and high availability, high quality, compliance with Standards, security, confidentiality, lower vulnerability, and scalability with electronic signatures.

Make sure you choose the right quality management solution considering the availability of eSignatures for improved validation of the processes, workflows, documentation, and much more.

Here’s one quick suggestion to make your job of finding the right QMS easy – Qualityze eQMS. It comes with a user-friendly interface on a cloud-driven platform. It offers organizations ample of features and in-built capabilities including eSignatures, Audit Trails, Email Approval, and many more.

This integration enabled solution allows you to form a closed-loop system for your quality processes including Nonconformance management, CAPA management, Document and Change control management, Audit management, Training management, Supplier management, and Customer experience management to mitigate the nonconformances/deviations/issues in comparatively lesser time while driving continuous improvement.

Whether you need an eSignature enabled QMS for healthcare, life sciences, manufacturing, or any other highly regulated industry, Qualityze is one of the most reliable solutions.

The Ending Note:

The age of digitization requires organizations to reconsider their documentation, validation, and approval process to meet the stringent compliance and quality standards. QMS with eSignature will make a suitable choice for all the organizations that want to cope up with the speed of evolution in quality space.