The MHRA released guidance on the 9th of April for good working practices whilst many of your employees adjust to working from home amid the current climate.
Where the company has existing validated electronic systems in place for electronic signatures this should where possible continue whilst working from home. The problem occurs where your company relies upon a printed version of the record or document which is then provided to the author, reviewers and approval persons to sign using a wet signature which is then implemented and filed accordingly.
So how do you ensure all parties required to sign are able to do so whilst working from home? How do ensure that all parties carry out the same process with no formal system to approve and sign?
The solution will vary depending on the availability of resource open to your employees whilst working from home and the document type that is requiring signature.
What resources are available?
Printer – most personnel working from home would have accessibility to a printer, is this useful on its own if there is no way of sending the wet signature back? It could be posted back, however, that is time consuming and there is potential for the document to be lost. You could upgrade to a courier but depending on the document this could become costly depending on how many parties are involved. You could use a driver again a costly and potential risk of spreading Covid-19 between employees thus defeating the purpose of working from home.
Therefore, wet signature unlikely to be a successful route in the current climate given potential cost and risk of contamination.
So, we have a printed document that you can wet sign but can not provide proof of signature. There are options here. Scan the document back if a scanner is available, email confirmation of approval, photo of the signed page using a smartphone etc are all simple solutions for a short-term signature issue. A more long-term solution would be to source an electronic signature method or third-party software that allows for the remote signature of documentation.
There are many options available to you and your company depending on the resource you have available. Once you have established what is available, you need to consider how you are going to retain document integrity and control:
- Carry out a risk assessment on your available resource and the documentation that will require a signature during this time period. You also need to consider the accuracy of the signature. How will you ensure the owner of the signature is correct?
- The more important the document, the higher the control required to ensure accurate approval and signature to prevent unauthorised approval.
- Where a signature is normally a wet signature, the system you implement must ensure that the new system has the same effect and is equivalent to the original system.
- The system implemented must be defined to ensure all personnel are working to the same approval process.
If you would like any further advice on data integrity or remote signing, please do not hesitate to contact Pharmacy Consulting Limited for further information.