Assessments
Knowledge & Expertise
Compliance and Quality Assessment Program An assessment program is vital to ensure your business meets industry standards
In regulated industries assessment plays an integral part in ensuring the quality of products and process controls.
Do you need help to accurately assess your current business practices, computer systems, software or suppliers, to ensure they are fit for purpose? Utilize Orise’s expertise to capture a baseline of your organization’s ability to meet applicable life sciences regulations and standards, such as FDA CFR Part 11, EMA Annex 11, GAMP (GxP applications), ISO 9001 and ISO 27001.
Our Compliance and Quality Assessment program has a number of touch points from which you can engage, depending on your business.
Assessments
Supplier Self Assessments
Where would you stand if you were evaluated by a life sciences company looking for a supplier? Is your business fit for purpose? Engage Orise to run a life sciences-appropriate supplier assessment on your business. We will identify potential exposures and help you to put in place an action plan for remediation.
System Assessments
Orise has global industry expertise in the assessment of GxP systems. We will assess your GxP systems, identify what is required to ensure they are fit for purpose, and analyze risks to produce effective validation test and risk mitigation strategies.
3rd Party Supplier Assessments
When you partner with Orise, we will execute supplier assessments on behalf of your organisation. We will assess your suppliers and let you know if they are fit for purpose for life sciences and your company. Orise’s Compliance as a Service (CaaS) model will help you own and manage an ongoing supplier assessment process for your business.
Quality Gap Assessments
Do you want to know whether your quality business processes would stack up against internationally recognised standards for quality management? Let our team of experts assess your business processes and procedures. We have a proven track record in successfully guiding companies to ISO 9001 and ISO 27001 certification.