Quality 4.0 - Addressing the challenges of the pharmaceutical industry.

Quality Management

Mai 23, 2023

The pharmaceutical industry is heavily regulated and quality control is a critical component of ensuring patient safety. Digital transformation can bring many benefits to the quality departments, such as improved efficiency, reduced errors, and better compliance with regulations.

However, there are also several challenges that need to be addressed to ensure a successful digital transformation in QM, including:

Introducing new digital QM platform: Especially the topic of training & change management systems is being an underestimated change for employees in the quality departments. Therefore, it is essential to have a comprehensive training program in place to ensure employees are comfortable with the new systems.
Data Integrity: The pharmaceutical industry generates a large amount of data, and ensuring its integrity is crucial. It is important to not forget about data integrity when creating user requirements specifications accordingly.
Regulatory Compliance: As we all know, the pharmaceutical industry is highly regulated and quality departments must ensure that any digital systems are validated and meet the relevant regulations such as the 21 CFR Part 11 and Annex 11.

Our IT-services in the field of quality 4.0 are designed to and address the challenges of the pharmaceutical industry to help our clients to improve their quality control and assurance performance, reduce costs, and achieve compliance with industry standards and regulations.

This includes the following services during pre-implementation, implementation, and post-implementation project phases:
Data & process modeling, quality management system implementation, test & validation, migration, service & support and training & change management.

Reference Project

In the initial situation, the customer faced the challenge of migrating documents and data from various sources without a defined scope or transfer format. To address this, our team provided the following deliverables:

First, Inconsult defined the scope and transfer format, ensuring a clear understanding of the project's requirements. Next, we deployed a migration appliance to facilitate the migration process along with defined and configured mapping and configuration rules to ensure accurate data transfer.

The migration execution involved multiple stages, including dry-runs, quality assurance (QA), and the final migration to the production environment. Throughout these stages, we conducted thorough verification to guarantee data integrity. Additionally, we created migration-related validation documentation in compliance with CSV (computer system validation) and SOPs (standard operating procedures).

Our contribution focused on two areas: defining the migration scope and mapping rules for QualityDocs and Training. By improving the data quality, we ensured a successful migration into Veeva QualityDocs and Training, the designated repository.

As a result of our efforts, the customer benefits from centralized and harmonized data stored in a single repository. The customer can continue to work with the data after migration, which means further processing of the SOPs or availability of the users' training records. This optimizes their business processes by providing easy access to information and eliminating the need for multiple systems. Furthermore, the migration allows for the retirement of the source systems, reducing maintenance costs and transitioning to a more efficient on-premises to cloud solution.

Our Service Portfolio

Data & Process Modeling
We provide business process analysis services to map and identify issues and opportunities for process improvements. This includes organizing and conducting process workshops, creating enhanced QM 4.0 processes based on our industry experience and delivering detailed documentation for the implementation of a new QM system and change management.
Quality Management Platform Implementation
We help clients to develop, implement and maintain Quality Management Systems that comply with industry standards and regulations. This includes reviewing existing systems, mapping and migrating existing data, as well as design a comprehensive solution tailored to the client's needs and validate the system to achieve compliance with industry standards and regulations.
Service & Support
We offer comprehensive service and support to help simplify our customers' processes, so they can focus on their core business while our experienced team takes care of the rest.
Training & Change Management
We provide training services in quality management systems to improve the client's internal capabilities in quality management. This includes planning and conducting of trainings in different settings tailored to the customer’s needs, such as workshops and individual training.