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eSignatures: Meet Regulatory Compliance with Paperless Validation

Disha Thakkar
March 27, 2020
Enable paperless validation for your testing workflows

Organizations across industries and sectors have gone paperless with the help of electronic document management systems and record-keeping. However, for compliance-driven organizations like healthcare and banking, this requires the substitution of actual signatures with electronic signatures.

Electronic signatures offer businesses a secure way of verifying authenticity of records and documents. How are these implemented?

In quality management systems, where approvals and reviews are required from various teams, often geographically dispersed, e-signatures streamline the workflow.

Let’s take the example of healthcare. When developing products – both software and hardware for use in the medical, pharma or healthcare IT systems, it is mandatory to follow a requirements and quality management process in line with FDA Title 21 CFR Part 11 set of Federal Regulations. These guidelines define the criteria for electronic records and eSignatures to be considered reliable, trustworthy and the equivalent of paper records.

Regulatory Compliance

The management of regulatory compliance is even more complex and challenging because of device proliferation. With so many new devices, apps and platforms coming in the play extensively, it requires additional layers of validation of the underlying software that the device and platforms use.

Modern Test Management Tools like QMetry support eSignature, Audit Trails and many other features that help teams to organize and manage their testing along with supporting compliance such as FDA’s 21 CFR Part 11. The main objective of QMetry is to empower teams and organizations by simplifying the validation of their software and thus help reach market quickly with confidence.

You can find out more about QMetry’s eSignature process and compliance with 21 CFR Part 11.

Paper-based validation

Why can’t you still go with paper-based validation? Consider this: It consumes on average 3300 pages of printed script copies. This means scanning of all the scripts with manual authentication. You can imagine the time, effort and overall cost of the project. Further, these costs are incremental because you need to maintain the documents in the same physical state for the stipulated time period using weather-resistant cabinets. Just one simple validation project can use up a large amount of paper and space and add to the documentation and wet approval overheads.

Faster turnaround time

Image eSignature Use Case

Further, when there is a paper-based validation process, teams have to wait for the authorized person to physically review and then sign-off the results. This leads to lot of time being wasted while waiting for the approval. Moreover, this whole physical process restricts teams and approvers to work separately. QMetry’s eSignature allows teams and the approvers to work from anywhere and get approval anytime from the cloud-based test management platform, thus saving a lot of time. From our assessment of both scenarios – 1. requiring physically to sign and 2. Using QMetry’s eSignature, we have seen there is 60-70% time saved on approval mechanism when you opt for QMetry’s eSignature feature over physical signatures.

The benefit is even more significant when you consider quality management systems and the approvals/reviews of geographically dispersed teams.

The system notifies owners and stakeholders about the status and state transitions through email alerts functionality.

Hassle free audits

Considering that every industry in Healthcare and Life Sciences needs to go through Inspections and Audits, we offer the most extensive audit trails to speed up this audit document preparation.

Healthcare companies can use Audit Log and Change Log reports. These reports are generated for the events, like Create, Update, Delete, Move, Copy, Archive, Unarchive, Clone, Add, and Remove, that take occur in QMetry. The reports include details like who carried out specific events, at what time, in which project and which module was affected because of the event.

QMetry understands the need of sharing these reports regularly with the concerned parties. To enable this, QMetry allows users to email reports in the PDF format and even automate their scheduling. Users can also check the scheduler history to view the history of scheduled reports.

Applicable across sectors

Rigorous compliance requirements and regulations set out by global regulatory authorities need the relevant industries like healthcare, pharmaceuticals, life sciences, banking, insurance to streamline their process of validation and demonstration of compliance based on the prescribed guidelines.

This demonstration of fitment is known as Computer Systems Validation (CSV) and is widely used across industries like food products, health supplement etc. that mandate eSignatures.

Conclusion

You can achieve faster implementation time, reduction in the overheads, high-quality compliance with standards, security, confidentiality, accessibility and scalability using electronic signatures.

Watch this video to find out how eSignature works in QMetry.

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