Q&A: Galderma
A new streamlined electronic approach for QA Audits and CAPA processes


Hervé Leroy, Quality Assurance
Galderma R&D


Q: What were the issues that led Galderma to choose an electronic-based solution?
A: Managing audit reports and follow-up actions were based on paper andit was neither an easy task, nor an efficient one.

Q: What were your goals with a new electronic system?
A: Galderma R&D, Quality Assurance planned to acquire an electronic tool that wouldenable QA to build the master audit plan, schedule individual audits, record and report findings, get response from audit contacts, allow response delegation, and monitor postaudit actions and other CAPA actions.

Q: Were there any other requirements?
A: Compliance with 21 CFR Part 11, zero-client, and easy integration with our existing e-mail system which is Outlook.

Q: Why did you choose CATSWeb for your overall solution?
A: CATSWeb was selected because it is a very configurable system. It could support our project, and also had the capability to support other issues/actions-based business processes, as well as the capability to support most of our QA activities.

Q: Why did you choose SysGen, Inc., an AssurX partner, to configure CATSWeb for your application?
A: Because CATSWeb required some enhanced configuration that we could not do internally. After only a one day meeting with SysGen, Inc., I was convinced that they had the necessary regulatory, technical and business expertise to help us.

Q: How has this streamlined approach using CATSWeb helped Galderma?
A: Several ways:

• Management has access to the audit information as soon as the audit report is issued. They can immediately manage the audit contact’s response, and therefore quickly respond to the situation.
  
• The Auditor can easily produce an electronic audit report, and follow post audit actions and due dates which are assigned to the Auditee.
• The Auditee can delegate the response to each issue with one click, but can still oversee and endorse the final response.
  
• QA management can oversee problems resolution and trigger CAPA when audit problems are residual.
  

Q: How have the users responded to the system?
A: QA and another department all feel comfortable with the new streamlined approach and the tool, which is very user friendly.

Q: Do you see any other applications that you might be configuring with CATSWeb in the future?
A: I am thinking of implementing a Change Request process with CATSWeb. CATSWeb will also be used to support any workflow based on issues, dispositions and actions.

Q: Now that you’ve had a chance to see CATSWeb and SysGen, Inc., in action what do you like best about the software and the consultants you’ve worked with?
A: They listen to you, take time to understand your business, and then propose pragmatic and relevant solutions. That was why we chose them.

Q: Would you recommend CATSWeb and SysGen, Inc. to others?
A: Yes, definitely!

About Galderma
Galderma is a global pharmaceutical company specializing in the research, development and marketing of therapeutic, corrective and aesthetic solutions for dermatology patients and a leading player in the worldwide dermatology market. Its expertise covers a broad spectrum of skin, hair and nail diseases.

Created in 1981, Galderma is a joint venture between Nestlé and L'Oréal and employs more than 2,600 people. The company has wholly-owned affiliates in thirty-two countries and a worldwide network of exclusive sales agents. In 2006, the company had global revenues of €687 million. Galderma’s website is www.galderma.com