Dangerous documents: bad habits that put your organization at risk
26 September 2022
Nancy Singer is an expert in compliance who advises teams in the pharmaceutical and medical device sectors. She was previously AdvaMed’s special counsel. She leads a course on ‘Dangerous Documents: Avoiding Land Mines in Your Emails and FDA Records’ that she has taught to more than 50 companies and at least 500 investigators from the FDA and compliance officers.
According to Singer, a ‘land mine’ is a record buried in your company’s files that, if discovered in a lawsuit, could blow up and cause significant damage to your organization. The thing about ‘land mines’ is that they are often unrecognisable as threats. For example, a simple sentence in a private email exchange, such as ‘This will be detrimental to our profits,’ could be a hidden landmine. As Singer explains, a plaintiff’s legal representative in a product liability case could find this statement and use it to undermine the credibility of a company.
How can company’s safeguard against ‘land mines’?
Whether you work in a small or vast organization, it’s important that your senior leaders take proactive steps to create a culture in which employees understand the risks that dangerous documents pose. All written communication should reflect the commitment to make safe and effective products that comply with applicable government regulations.
Individuals across the workforce need to learn how to embed positive habits into their work processes in order to protect both themselves and their organization.
Top 5 recommendations for organizations:
Define expectationsMake clear the expectation that employees will communicate in a safe and appropriate way.
Educate and trainCreate mandatory training on how to write in a professional manner.
Evaluate and provide feedbackEvaluate employees’ written communication style during annual appraisals.
Use a secure document collaboration toolIdeagen’s PleaseReview software provides a secure platform for real-time collaboration on documents. The automatic report of all document activity makes it easier to spot, and remove, potential ‘land mines’ before they become dangerous.
Use an email management solutionAn email management tool can help you centralise the storage of all business-critical correspondence.
File collaboration: 3 bad habits
Sharing and reviewing documents over email
Although there are web-based platforms for document collaboration, many people still prefer to collaborate on documents via email. However, this method can present a security risk. When confidential documents are sent back and forth between stakeholders, the security of sensitive information is compromised. This risk is particularly important when collaborating with third parties as commercially confidential information (CCI) may be exposed.
Lack of version control
Additionally, when employees use email as the primary tool for collaborating on, and sharing, documents, it is difficult to guarantee that the file you are viewing is the latest version. The lack of version control makes it difficult for the document owner to consolidate, and control, the edits that have been made to a document by multiple stakeholders. This increases the risk that ‘land mines’ may be added to a document and not picked up by the document owner—particularly if the document is very long and complex.
Using basic document collaboration platforms
In most file collaboration platforms, document owners do not have visibility of all activity. As contributors may edit sections that have not been assigned to them, this may cause conflict and confusion as to who has changed what. The document owner may struggle to reconcile conflicting edits and comments.
Additionally, whenever you need a third party to collaborate on a document within most web-based collaborative platforms, you must give them access to your server. This poses a security risk to your organization.
How can companies use tools and training to change employee behaviour?
Singer recommends that organizations can implement half-day training sessions where the instructor asks participants to analyze company documents from the perspective of an industry regulator or a plaintiff’s lawyer. She suggests that a simulated trial can be a helpful exercise. In this scenario, employees would be asked to defend communication in company documents. Additionally, workshops in rewriting correspondence can help improve writing skills.
Technology can also play a key role in helping companies to mitigate the risks caused by hidden ‘land mines’ in documents. With Ideagen PleaseReview, high-volume teams can collaborate in real-time on a version-controlled document. Users can see each other’s changes and respond in real-time to any disputes and flag additions that may be problematic. Advanced redaction capabilities also enable teams to redact CCI and PPD (with categories for each).
Additionally, the software captures all document activity in an automatic reconciliation report. This gives the document owner full visibility, and control, of all changes and comments. The document owner has greater reassurance that ‘land mines’ will be picked up more quickly and dealt with appropriately.
Moreover, the web-based platform makes it easy for employees to collaborate with third parties while controlling precisely what they have access to within the document. This ensures that commercially confidential information is protected.
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