Life Sciences organizations have unique challenges in addition to the 'standard' internal controls over Financial Reporting. The need to not only protect patient data, but also protect intellectual property and the outcomes of areas such as Clinical Trials, and the ultimate manufacturing process for the product or drug process.
Data Integrity Issues:
Risk: Insufficient segregation of duties may lead to data integrity issues, such as unauthorized access, manipulation, or deletion of critical research or production data. Example: If a single individual has both the authority to enter and approve data without independent verification, the risk of data manipulation or errors increases.
Regulatory Compliance Risks:
Risk: Failure to comply with regulatory requirements can occur if duties related to compliance oversight, documentation, and reporting are not properly segregated. Example: If the same person is responsible for both conducting quality audits and implementing corrective actions, there is a risk of bias and potential non-compliance.
Fraud and Misconduct:
Risk: Inadequate segregation of duties can create opportunities for fraud or unethical behavior, especially if individuals have unchecked control over financial transactions, procurement, or research data. Example: A researcher who is also responsible for budgetary approvals may be tempted to manipulate results to secure additional funding.
Supply Chain Vulnerabilities:
Risk: In the life sciences sector, supply chain integrity is crucial. Lack of segregation of duties in procurement and inventory management may result in vulnerabilities, such as unauthorized access to and distribution of pharmaceuticals or medical devices. Example: If an individual has control over both procurement decisions and inventory management without proper oversight, the risk of theft or mismanagement increases.
Research and Development Risks:
Risk: In research and development, inadequate segregation of duties can compromise the integrity of scientific experiments, data analysis, and reporting. Example: If the same person is responsible for conducting experiments and approving the findings without independent review, there is a risk of biased or inaccurate results.
Quality Control and Assurance Risks:
Risk: If there is insufficient segregation of duties in quality control and assurance processes, there is a risk of overlooking critical quality issues or approving substandard products. Example: Allowing the same individual to both perform and approve quality control checks without independent verification could lead to compromised product quality.
In addition to increasing pressure from legislation, another factor needs to be considered. Enterprises are now running over 400 applications on average. This growing number of applications increases the risk footprint for segregation of duty violations, configurations, and access to sensitive data. How are the risks within and across these applications being evaluated and tested?
Seecuring is Security as a Service, combining Technology and Resources to help you identify and resolve access and identity problems, including:
* Analysis of access to the Sensitive and Critical elements of the Applications, both detective and pro-active.
* Segregation of Duties analysis and remediation.
* Review the impact of making changes to your security and make the right decisions to get your Controls and Configurations resolved.
* Assign actions to your team for fixing issues.
* Create exceptions to Violations, stored and ready to be reported on as part of your Access Certification - sometimes Users need to break the Rules and you will have compensating controls.
* Identify and work with you to create processes to manage Support and System/Power Users such as the Administrators.
There is no software to deploy or install, and our solution of Technology and Services is based on a Subscription so you know exactly what your costs are and the outcomes you can expect.
We support any application, including those for Healthcare and Life-Sciences such as Oracle ClinicalOne, Peoplesoft, Salesforce and many more industry applications. This is in addition to the major ERP applications such as Oracle ERP Cloud, E-Business Suite, JD Edwards, Netsuite, Workday, and more.
For 21CFR Part 11 Compliance, Seecuring provides solutions to help manage the controls around permisions in your applications that relate to electronic records, signatures, and the auditing of that information.
From protecting clinical trial information, through to the segregation of duties within your healthcare applications, Seecuring covers all of your applications and services.
We have been working with ERP/HCM Applications since the early 2000's, and work with leading CPA's, Audit staff and Application specialists to deliver a complete solution.
Before you invest in expensive Software, why not look at GRC as a Service? Faster delivery, lower cost, and more than just reports on your issues - we help Organizations achieve their goals for Internal Controls.