Adopting E-Signatures in a Regulated Environment

Introduction

There’s often a reticence around adopting electronic solutions for traditional processes – EDC took hold across the industry, but it was a long slow introduction.  ePRO is starting to take off now too, but we are not natural adopters of e-systems that have been common for years in other industries.

With regulatory restrictions requiring multiple signatures on many controlled documents, and global teams participating in trials, obtaining “wet ink” signatures can be a challenge – you can end up with multiple original and scanned versions of the same document. This means that when reviewing study documentation, for each signed document there can be multiple versions to monitor, maintain and file.

Added to this, the physical cost of paper, printing, postage and management of such documents can be significant. Electronic signatures, once introduced and adopted can significantly cut the physical and virtual costs of something so intrinsic in what we do.

SQN’s experience

At SQN, we have been using electronic signature systems for almost four years.  We are seeing significant time savings in the obtaining, administration and management of signed documents.  Of course there is an overhead to get such a system up and running – for efficient and consistent use some work is needed in setting up templates – depending on the system you select, you may need to adjust your standard document templates and possibly create additional signing templates within your electronic solution. After that, with appropriate policies, administration and training for users, the system runs very smoothly. From the perspective of corporate and social responsibility you can expect to be making significant changes – in a year we saw a carbon footprint reduction in the region of:

• 1,700 kg of wood
• 39,000 litres of water
• 4,000 kg of CO2
• 250 kg of waste

Which Provider?

There are a number of providers of 21CFR Part 11 compliant systems meaning the market has opened up significantly, and introducing e-signatures is more affordable than you think. Before going out to look for a provider consider-

• The number of licences you need – how many users in your organisation need to send documents for signature on a regular basis? Normally anyone can sign a document without a licence, most plans are based on the number of “sender” users.
• The number of documents you are likely to send for signature in a year – some providers price themselves out of contention by applying low limits and introducing significant charge for high-volume use.
• A good provider will include 24/7/365 technical support with your account.

If you’re thinking about introducing electronic signatures, here are some key features that you should ensure your selected system provides:

• Administrator control – Not only for user management, it’s also important to be able to recover documents in the event of someone being unexpectedly unavailable so that required signatures can be captured, and the TMF can be kept properly up to date.
• Signature Templates – To ensure ease of use for all those who will be sending documents for signature, the ability to set up your documents for consistent and simple signature gathering is key. What this means is that your chosen system will recognise where signatures are required on your documents and automatically assign the signature “tags” so all your user does is upload the document, and enter the email addresses of the signatories.
• In-flight document updates – During the gathering of signatures, it’s not uncommon for a required signatory to be unavailable. It’s useful to select a system which enables an in-progress document to be re-routed to an alternative person to ensure all signatures are gathered in an appropriate and timely manner.
• Mobile application – it’s not a deal-breaker, but it can be very useful to give people the opportunity to sign documents on a mobile device. A good e-signature system will natively provide an app that ensures adherence to 21CFR Part 11.

Summary

As with any significant change in the way a business operates, there’s an overhead. Any system requires qualification or validation and ongoing oversight.  At SQN we found that with a well-organised approach the introduction of e-signatures was smooth and simple, and it soon became embedded in the business.  The savings both in time, consumables and document loss risk are significant.