Life sciences: inspection readiness
Challenge:
To accomplish this task, our client raised concerns over the organization of validation documentation and whether computerized systems met the guidelines set forth by regulations. The company was faced with the challenge of implementing a global program for system validation that would satisfy industry standards and guidelines and need to:
- Create a procedure and an assessment to assign minimum documentation requirements based on the risk impact of a system
- Be able to understand the intended use and validation of different computerized systems by speaking with the appropriate stakeholders
- Assess the accuracy, completeness and relevancy of validation packages in regards to each system’s validation plan and industry standards
Solution:
In order to be successful in creating a global standard for system validation, Integrity applied a project management framework targeted at developing a consistent approach to inspection readiness. During the implementation of this approach, Integrity executed the following tasks:
- Identified high risk systems and their respective stakeholders that were most critical to our client’s activities
- Developed appropriate procedures and templates for the assessment of computerized systems
- Conducted risk impact assessments in order to assess the regulatory risk of each computerized system and which minimum documentation requirements would be appropriate
- Completed Compliance Summary and Action Plans (CSAP) in order to analyze the validation documents and determine system fitness
- Performed risk assessments and CSAPs across several sites throughout the US and in Europe
- Identified the locations of documentation in order to facilitate future inspections and possible efforts to centralize document management
Results:
The Mazars team was able to complete assessments within the project timeline and created added-value for our client’s IT department and Quality Management system. Overall, by using a risk-based approach, the project provided value in the following ways:
- Identified validation documentation and prepared system stakeholders for the quick turnaround that is expected in inspections
- Created standards and requirements for assessing whether the validation packages of critical computerized systems are adequate enough to pass inspection
- Increased buy-in and support from senior leadership within IT and across the Business as to the efficacy of the assessment process
- Implemented a standardized assessment process across the business, both in the United States and in Europe
- Identified and resolved gaps in critical systems across the business
- Identified critical systems that would require remediation in the future
The information provided here is for general guidance only, and does not constitute the provision of tax advice, accounting services, investment advice, legal advice, or professional consulting of any kind. The information provided herein should not be used as a substitute for consultation with professional tax, accounting, legal or other competent advisers.