New Pharma eQMS: Enhanced Computerized System Validation (CSV) for Quality and Compliance

CSV | eQMS | CAPA | 21CFR part 11 | Data Integrity | Standards | Audit trail

The Importance of CSV in the New eQMS to Ensure Accuracy and Data Integrity in the Pharmaceutical Industry

Advantages of eQMS?

The pharmaceutical industry is subject to rigorous requirements for quality, safety, and regulatory compliance. In this context, the adoption of a new electronic Quality Management System (eQMS) promises to significantly improve management processes. One crucial aspect of this new eQMS is the implementation of Enhanced Computerized System Validation (CSV). Our expertise in this field aims to ensure the accuracy, integrity, and compliance of data in the system implementation and throughout the life cycle of pharmaceutical products for our clients.

The CSV of this new eQMS is of paramount importance for our clients, either during the installation of a first eQMS or, for example, after the acquisition of a Contract Development and Manufacturing Organization (CDMO) by a new pharmaceutical group and the change of the existing system to a new one to meet the needs. It ensures the reliability of information used throughout quality processes. System validation relies on procedures that we have established for identifying specifications during multidisciplinary meetings with holders of different processes and rigorous steps to ensure data quality.

The challenge

One major challenge we faced during the project was the comprehensive collection of data without loss of information. However, thanks to this new eQMS, the company can now gather all relevant information from different departments after an analysis of specifications that we conducted with various Process Stewards in a centralized system. This facilitates the complete collection of data needed for thorough CSV.

The complexity of data and processes is also a significant challenge. However, this new eQMS integrates advanced features that efficiently manage this complexity, allowing me to propose Design Changes for document and process template modifications to better meet the expectations and needs of end users. Appropriate technological tools, such as change tracking and data traceability through an Audit Trail, simplify CSV and facilitate the detection of potential errors or inconsistencies in information.

Another essential challenge in current industries is the lack of resources and specialized skills. Pharmaceutical companies must invest in staff training to ensure competence in CSV implementation. Awareness of the importance of CSV and its role in ensuring quality and compliance is crucial for the success of this transition. This is where our guidance and support come in, leveraging our expertise and competent resources to fill and strengthen teams for efficient and comprehensive CSV implementation.

Benefits

• CSV in this new eQMS offers significant benefits for the pharmaceutical industry. By ensuring the accuracy and integrity of data, CSV strengthens regulatory compliance in accordance with 21CFR part 11. Companies can quickly identify and correct potential non-conformities following deviations and complaints diagnosed and recorded in the eQMS. They can also implement and track action plans for Changes and Corrective and Preventive Actions (CAPA) necessary for improving industrial activities, thereby reducing the risks of costly sanctions and disputes.

• Furthermore, effective CSV promotes informed decision-making. Verified and reliable information allows decision-makers to formulate strategies and plans based on solid data, enhancing competitiveness and success in an ever-changing environment.

• Finally, enhanced CSV in the new eQMS contributes to improving the reputation of pharmaceutical companies. By providing high-quality products and services, adhering to quality and compliance standards, companies gain the trust of stakeholders, including patients, regulators, and business partners.

• In conclusion, the adoption of a new eQMS in the pharmaceutical industry is a major advancement for quality management. The implementation of enhanced Computerized System Validation (CSV) offers considerable benefits in terms of quality, compliance, and informed decision-making. Comprehensive data collection, managing complexity, staff training, and the use of appropriate technological tools are pillars supporting this initiative. CSV, in particular, proves to be a cornerstone in this effort.

Companies embracing this approach will be better positioned to:

• meet regulatory requirements,

• maintain their reputation,

• and provide high-quality products and services to their customers and dependent patients.

Ultimately, CSV in eQMS is a crucial step toward a safer, more efficient, and transparent pharmaceutical industry.

However, to remain competitive and relevant in the future, companies must be ready to constantly adapt to technological advancements, stakeholder expectations, and new regulatory requirements.

The need of CSV experts

Alispharm is well-equipped to address a crucial challenge faced by industries today – the shortage of resources and specialized skills in the realm of Computerized System Validation (CSV) implementation. Recognizing the significance of CSV and its pivotal role in maintaining quality and compliance is essential for the success of this transition.

In response to this challenge, Alispharm positions itself as a valuable ally, offering guidance and support. The company leverages its expertise and competent resources, including the vibrant CSV community at Alispharm. This community serves as an additional dimension, fostering collaboration and knowledge-sharing among experts within the organization. Together, they assist pharmaceutical companies in overcoming resource and skill gaps, contributing to the efficient and comprehensive implementation of CSV. Alispharm’s commitment extends beyond individual expertise to collective strength, further enhancing teams and facilitating a successful transition in the industry.