# Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a0d3c724-6cb5-452c-8f41-a04d3e47a258 Type: Detailed Guide Published: April 9, 2020 > The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued this guidance to address challenges in approving paper documents during the COVID-19 pandemic. As remote work became standard, traditional wet-ink signatures for documents like validation protocols, risk assessments, and standard operating procedures (SOPs) became impractical. This guidance applies to all organizations within the pharmaceutical lifecycle, including those governed by Good Manufacturing, Distribution, Laboratory, Clinical, and Pharmacovigilance Practices (GxP). While existing validated electronic systems are preferred, the MHRA allows alternative methods—such as secure email or third-party software—provided they maintain document control. Key requirements include ensuring that remote signatures are equivalent to handwritten ones and are strictly attributable to the individual owner to prevent unauthorized use. Organizations must define their document distribution and approval processes clearly to minimize errors and ensure that remote reviewers have access to all necessary supporting data. A risk-based approach is mandatory, following regulatory frameworks like EU GMP Chapter 4 and Annex 11. Critical actions include ensuring documents cannot be altered after signing and maintaining a robust audit trail. While this is general guidance rather than a specific company inspection report, failure to implement these controls could lead to data integrity issues and regulatory non-compliance during future inspections. --- ## Content Due to the COVID-19 pandemic, remote working has increased. Some organisations have advised that their processes for approving paper documents with wet ink signatures are no longer achievable. This guidance is to enable organisations to consider alternative methods whilst maintaining basic control of documents. The guidance is for organisations involved in the pharmaceutical lifecycle ( GMP , GDP , GLP , GCP & GPvP ) or GLP studies regulated by the MHRA. Existing electronic systems Many companies already have validated systems that support electronic signatures on systems that are available remotely. If a company has these systems in place, then they should continue to use them. Paper documents that were approved with wet ink signature These are documents that have traditionally been printed on paper, physically handed to each reviewer in an office and approved using wet ink signatures. Examples may include, but are not limited to: Validation protocols and reports Risk assessments Technical reports Quality management system documents that are paper-based such as SOPs , investigations and change requests. These can be shared with remote workers, but they have no formal system describing how the review and approval can be recorded. Alternative methods The solution will vary between organisations depending on the type of document and the tools available to the person performing the approval e.g. printer, scanner/smartphone, secure email, third party software or existing systems that have tools to capture electronic signatures. Principles to maintain control Regardless of what system or process is used, the following principles apply: Controls should be proportionate to the risk considering the type of document and the methods used for distribution and approval A signature performed remotely should be equivalent to the handwritten signature of the signatory The method of document distribution and approval should be defined to minimise the risk of error due to misunderstanding of what is being reviewed/approved Risks with remote approval Aspects to consider when assessing risk include: How the approval signature is attributable to an individual Whether there is a legislative requirement or GxP guidance for a signature. If there is, then the signature should be considered more critical and have proportionately greater control - for example when a QP certifies a batch of finished product to enable release for sale The security of the electronic signature i.e. so that it can only be applied by the ‘owner’ of that signature How the act of ‘signing’ is recorded so that the document cannot be altered or manipulated without invalidating the signature or status of the entry Ensuring that all required associated data is available to a remote reviewer that would have been available to them if they were performing the review at a site Some examples of issues with remote approval are included in Examples of issues with remote approval ( PDF , 305 KB , 4 pages ) . In these examples, had the distribution and approval process been clearly defined and assessed, it is unlikely that these issues would have occurred. Further information MHRA guidance on GxP data integrity EU GMP Chapter 4 EU GMP Annex 11 Guidance for clinical trials: joint HRA and MHRA statement on seeking consent by electronic methods We have also published i nformation on arrangements for MHRA Good Practice ( GxP ) inspections due to coronavirus (COVID-19) . ## Attachments - [Examples of issues with remote approval](https://assets.publishing.service.gov.uk/media/5e8f2980e90e071a166ed19a/Examples_of_issues_with_remote_approval_-_April_2020.pdf)