Case study

About Purdue Pharma Canada

Established in 1952 in New York, Purdue Pharma, formally Purdue Frederick, began its operations in Canada in 1956. Purdue Pharma Canada specializes in manufacturing a wide range of products, including laxatives, bronchodilators, antiseptics and analgesics.

Key drivers for going electronic

In 2005, the need to better control resources initiated the e-QMS project at the Pickering, Ontario, Canada site. Gino Garofalo, Director of Quality Assurance, was the project leader. When interviewed about the initial drivers in wanting to go electronic for Quality Management, he stated that the major issue was control- many different changes were issued on paper-forms for different Quality Processes and it was very difficult to find the link between them all. There were some concerns because documents came missing. He recalled a few incidences in which important documents were misplaced and the time loss in searching for those documents became a worry.

Key reasons for selecting SOLABS QM

In selecting their e-QMS system product/provider, Purdue Pharma established a list of priority criteria. The first important element was the service contract. They were looking for a vendor that would have the ability to have an open dialog and discussion in real-time. The flexibility and adaptability of the product to Purdue Pharma's way of doing things, and not-vice versa, was crucial. The cost of the product was also a key selection factor: budget needed to be respected. Following the evaluation of different offers, SOLABS was the vendor selected as they could execute all those criteria.

The Purdue Pharma implementation team

As in most of SOLABS client cases, Purdue Pharma being a mid-size Life Sciences company, the client effort was limited to a team of 7 individuals. Primarily, the team composed of a team leader, the Quality Assurance Manager as well as 6 staff members from Quality and Validation departments.

The SOLABS implementation team

The SOLABS implementation team includes 5 to 7 staff members. In this case, a project manager, a technical lead, a business process, validation and a technical support specialist.

Lessons learned by Purdue Pharma from the implementation

For Purdue Pharma, the biggest lesson learned from the SOLABS QM Implementation project is to make sure key staff members are trained thoroughly on the system. A better knowledge of the system will allow for better training of staff on a larger level as well as tailoring of the product to the companies' specific needs.

Lessons learned by SOLABS from the implementation

SOLABS always recommends that the total e-QMS implementation project be spread out in different phases. The product should be deployed in several waves. For example, in phase 1, clients can start by using the system for Document Control as well as Change Control and then add more processes, such as CAPA, Deviations and OOS in phase 2.

Benefits of SOLABS QM at Purdue Pharma


  • Visibility: Information is available in real-time- simply press a few buttons and quickly obtain a summary of the evolution of any Quality Process or task at any given time.
  • Time saving: The system allows processes to move more smoothly. Staff members do not waste time searching for paper documents. Real-time reporting on the state of each task allows for better control of human resources. The time saving on clerical tasks has allowed Purdue Pharma to initiate more Change Control Processes, these causing significant improvements on the Quality side of things.
  • Reducing the effort of preparing for audits: Auditors still prefer to deal with hard copies, paper-documents so all documents must be printed prior/ during their visit. However, documents are easily traceable and the time spent on preparing the information is greatly reduced. Also, the control of documents printed from SOLABS QM is much stronger as validity watermarks are automatically generated when printed. Auditors also appreciate the fact that all users work within the same unique system and, therefore, there is no discordance in information between different departments.

Conclusion

As a final point, SOLABS QM is seen as a competitive advantage at Purdue Pharma. Going from paper to electronic has definitely changed the way people work and improved the way Quality Assurance is managed within the company.

View our webinar: A Quality Management System Customer Success Story with Purdue Pharma