Total Quality and the Meaning of Data Integrity

Due to their direct impact on the health and even lives of patients, quality control and quality assurance are of paramount importance in the Life Sciences industry. All stakeholders; government agencies, manufacturers, distributors and healthcare professionals therefore take the issue of quality very seriously. We asked 5 questions to Alban van Landeghem, Sr. Life Sciences Business Consultant at Dassault Systèmes about Total Quality, a concept of high priority for Life Sciences solutions at Dassault Systèmes.

1. What is Total Quality?

“Total Quality[1] is a systemic view over the quality of the product and all processes related to the entire development and production process,” says Van Landeghem.  “In the Life Sciences industry, everyone considers the end user of a drug or device:  the patient. In order to provide the patient the best possible supportive care, each step in the therapeutic  solution lifecycle from development, manufacturing, distribution and management of bulk, intermediate or even final materials needs to be considered.”  Total Quality is the integrated framework that inserts controls and best practices at each step of the product lifecycle.

This total quality objective has one goal: provide the best efficacy and safety for the manufacturing of medical solutions, such as described in the International Council for Harmonisation[2] standards.

While Total Quality concepts have been developed first in the automotive industry[3] for understandable reasons, pharmaceutical quality is of equal if not even more importance.  “Users choose to drive a car knowing the risks, patients suffer their illness without being able to choose their drugs”.  Therefore, a systemic quality approach guarantees a level of confidence of appropriate efficacy and safety as accepted by market authorization.

2. What does Total Quality consist of?

Total Quality consists of the control of all elements, processes and behaviours that lead to the manufacturing of the product as designed and as registered. “For years, the Life Sciences industry has been very committed to delivering the best in class products to patients. To do so, standards and guidelines are continuously improved. For example; drug manufacturing guidelines such as Good Manufacturing Practices[4] [5]( GMPs)  advise companies on how to manage their quality systems, but also how to maintain their human resources knowledge and know-how.”

Manufacturers need to consider the importance of having the right people in the correct role, in the correct location, with the required knowledge and training.  GMPs also address buildings and facilities configurations: control of energy used in production, sanitation, calibration and validation of equipment.

On top of this comes the required records and documentation. Any process needs to be described in standard operating procedures (SOPs) and Work Instructions (WI) in order to convey only best in class practices. Any product (bulk, intermediary, final) being released needs to be checked through quality control processes. As quality control was typically processed at the end of operations, new approaches considering Quality by Design can involve Process Analytical Technology tools as well as allowing control to take place earlier in the process.

Once established, these quality control activities need to be audited and tracked to ensure products suit the established specifications in the marketing authorisation file.

The reason “Total Quality” is so comprehensive in pharmaceutical development is because drugs should be manufactured as designed and as registered. “And it is important to note that Total Quality extends to the whole lifecycle of the drug,”

3. What is needed for Total Quality?

“To streamline Total Quality, Life Sciences companies need, above all, a complete and 360° vision of their enterprise operations. Dassault Systèmes delivers management of quality processes through the 3DEXPERIENCE platform, which helps users answer the specific needs of several industries – Life Sciences included”.

“The 3DEXPERIENCE Platform provides roles for collaboration, design, simulation and real world analysis that will help, when properly deployed and installed, the final decision-maker to envision, based on digital experiences, the best decisions to take. The 3DEXPERIENCE Compass will indeed guide the decision-maker in its quality journey.”

4. What is the role of Data Integrity in Total Quality?

Data integrity[6] is not a new concept especially not in Life Sciences. Data integrity was as important for paper-based records as it is for electronic records. Data integrity refers to the completeness, consistency, and accuracy of data.

It is a minimal requirement to guarantee trust among regulatory bodies, the Life Sciences Industry ecosystem and not least patient communities.

These data integrity requirements are applicable to each step of the development of a drug or therapeutic device, from research, lab development and experimentation, manufacturing, distribution, and finally, administration.

Data Integrity processes are a prerequisite to ensure the end user that drugs or devices are manufactured by processes and without the corruption of data, delivering the exact benefits as expected and approved by regulatory bodies.

Data Integrity plays a very important role in gaining the trust of regulatory bodies. “For one, involved IT solutions need to be able to guarantee there has not been any information breach and that all data has been inputted by authorised staff.” Data also needs to follow ALCOA guidelines: attributable, legible, contemporaneous, original and accurate. “So you need to know who recorded the data, it needs to be readable, recorded at the time the work is performed, and in the right protocol from the primary data source, and of course complete and free from error,” Van Landeghem summarises.

5. How do you guarantee Data Integrity?

Industry standards like ALCOA guidelines have consequences for the use of technology in quality control. “The platform needs to be controlled, verified, validated and secure,” Van Landeghem says. “That means strong password protection. It should also take into account the stage of development provided by R&D departments.”

For more information about Dassault Systèmes work in the Life Science industry please see here.

[1] Total Quality Concept has originally been developped by Pr Kaoru Ishikawa, University of Tokyo in 1962.

[2] https://www.ich.org/products/guidelines.html

[3] Toyota

[4] https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf

[5] https://ec.europa.eu/health/documents/eudralex/vol-4_en

[6] FDA, Data integrity https://www.fda.gov/media/99556/download