Establishing a Global Data Integrity Program for a Beauty Company
Clarkston Consulting recently partnered with a client in the beauty industry on a global data integrity program. Read a synopsis of the project below or download the full case study.
Over the last several years, data integrity has been a hot-button issue as regulatory agencies have been continually finding problems with falsified data through their auditing programs. A data integrity problem is a clear indication of a lack of control by the Quality group and is a starting point for many audits these days.
Clarkston recently helped establish a global data integrity project for a beauty company. The client is a worldwide manufacturer, distributor, and marketer of cosmetic products in the health and beauty industry. This data integrity work encompassed the areas of Research & Development, Information Technology, and Global Supply Chain. Clarkston was able to quickly establish a great rapport with the client and demonstrate value by triaging various issues, establishing action plans to prioritize certain activities over others, and progressing through an extensive list of issues identified by an independent auditor.
Download the Global Data Integrity Program Case Study Here
Throughout the project, Clarkston wrote, reviewed, or revised more than ~340 documents, including standard operating procedures, process/guidance documents, and manuals across numerous areas, including: asset management, change control, clinical studies, compliance, computer systems, contract testing, data management, documentation, forms, lab audits, lab equipment, lab instrument qualifications, lab methods, lab processes, lab sample handling, lab waste, QA audits, regulatory requirements, security, shipping, training, and vendor management.
In addition, Clarkston worked with the client to drive the importance of data integrity to the forefront of the business, as data integrity is now a part of new hire orientation and recurring training requirements for employees in R&D, IT, and Global Supply Chain. Each of the company sites employs a Data Integrity Site Coordinator to ensure compliance with data integrity procedures developed in cooperation with Clarkston. As a result, Clarkston helped to support the client’s data integrity remediations and implemented a global data integrity program across seven different company sites around the world, ensuring site compliance and readiness for data integrity audits.
