No rules no standards. Without compliance, there is no business tomorrow.
Compliance is a typical "zero-sum game". An unsuspecting ransomware attack, an unplanned downtime event, or a list of violations analyzed on a piece of paper may cause a company's business and goodwill to "lose both" and fall into an irreversible situation. . Fantasy wandering in the middle? nonexistent. In other words, companies should firmly establish bottom-line thinking and never take chances.
At present, enterprises' reliance on the cloud continues to increase, and the distribution of IT infrastructure and data resources tends to be decentralized. Management, compliance and legal teams urgently need to adopt sufficiently robust and flexible data management strategies to effectively respond to compliance requirements and reduce potential risks— - For example, finding, controlling and trusting data, whether at the infrastructure level or the enterprise data environment level; retaining and preserving electronic data to meet government and/or industry regulatory requirements; large amounts of electronic content need to be managed and processed in accordance with company internal policies; Reducing the holding of unnecessary data... The above application scenarios will be the "responsibility fields" of corporate entities in all walks of life.
In terms of its own attributes and business characteristics, the pharmaceutical industry is a representative of "strong supervision", integrating the cutting-edge practices of "Tao and Technique". With the continuous implementation and updating of industry regulations, more and more pharmaceutical companies have reported that the challenges they face in data management are increasing day by day. Ensuring the authenticity, integrity and reliability of data has increasingly become an urgent issue for the entire industry.
Key words of pharmaceutical compliance from the perspective of GMP
Global collaboration on compliance and regulation will become more common in recent years. In essence, the core of pharmaceutical supervision will change from "compliance with drug GMP" to "continuous compliance with drug GMP". You know, as early as 2015, the pharmaceutical industry was not a "mainstream track", with many thorns, but it was also giving birth to infinite possibilities. After that, with the rise of the concept of "Internet +", some investors proposed to subvert the traditional industry, and naturally turned to the medical industry.
However, at a time when the drug supply chain is increasingly complex, GMP compliance is critical, from manufacturers to regulators to consumers. Some producers end up paying dearly for GMP violations - factories closing or shutting down production until regulators deem it safe to produce there. Even as far as the current situation is concerned, most companies have obvious "gap" in data management, mainly in the following aspects:
First, the management level of different types of pharmaceutical companies varies greatly. For example, emerging biopharmaceutical companies attach great importance to GMP compliance, especially in terms of data governance and data integrity, which are in line with international standards. Traditional medical devices/equipment and traditional Chinese medicine companies pay less attention to data compliance.
Second, IT lacks an understanding of compliance business scenarios and effective communication with the "gatekeeper" - the quality assurance (QA) department. Some enterprise CIOs and management are "out of position" and do not fully coordinate IT to support business and manage electronic data in a compliant manner. If the parties cannot form a joint force, they are naturally unable to meet the data protection requirements under GMP compliance.
Third, going overseas is the general trend, and pharmaceutical companies with numerous subsidiaries and production operations all over the world have become the mainstream. How to implement unified data management and meet a series of international compliance requirements such as China's NMPA, US FDA, EU Annex 11, and EU EMA are issues that these companies must consider.
On May 10, 2021, the General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening Drug Regulatory Capacity Building". It pointed out: improving the standard management capability, that is, strengthening the construction of the drug standard system, improving the standard management system and measures, and strengthening the refined management of the whole process of standard formulation and revision; improving the information traceability system, that is, to give full play to the traceability data in risk prevention, product recall, emergency response Disposal and other work, improve the level of supervision refinement; promote the digital management of the whole life cycle, that is, strengthen the development and utilization of relevant data such as government departments, industry organizations, enterprises, and third-party platforms, and research and explore key common technologies and applications based on big data. , to promote the upgrading of supervision and industrial digitalization.
With the continuous improvement of domestic and international drug regulatory requirements, the industry is more looking forward to the specific implementation path to meet GMP compliance.
Therefore, GMP data protection needs to complete computer system verification (CSV) requirements, emphasize data integrity, and form traceable documents to ensure the ability to respond to audits and meet compliance requirements. There are techniques that can help companies ensure the reliability of GMP data generated and maintained in electronic systems, such as verification of program controls, technical control tests, etc.
Integrated solution to three core challenges
There is no shortcut to compliance, the process must be perfect, GMP must be followed, and data must be safe.
If GMP certification is related to the survival of enterprises, CSV verification is related to the survival of IT departments. In pharmaceutical companies, CSV verification is required for all business data related to GMP. Therefore, pharmaceutical companies need to confirm the IT infrastructure, because IT infrastructure has a significant impact on data integrity, both a regulatory requirement and a regulatory requirement. Second, you need to ensure that the IT infrastructure is in a compliant and controlled state before applications can be deployed on IT equipment.
Because, CSV verification is the only way to assist the production department of the enterprise to improve GMP compliance.
In the process of continuously improving the informatization level of drug production and quality management in the pharmaceutical industry and establishing a drug traceability system, it is inevitable that some special functions will be customized in the process of implementing an informatization software project, and even a complete set of software systems will be customized. Therefore, once CSV verification is often ignored by enterprises, data security-related problems occur, and the entire IT department and even the core business will face collapse. IT, in particular, should learn from it, abandon "short-sighted" thinking, guide practice with the concept of "long-termism", and design a complete data protection and management platform from the perspective of continuously satisfying compliance.
All in all, in the face of the information construction of the pharmaceutical industry, the top priority is to create a unified data protection management platform, implement global management, form standardization capabilities, and fully cope with the three core challenges of complexity, scalability and flexibility:
In terms of coping with complexity, the system platform should focus on breaking down barriers, avoiding data management "separately managed" and falling into the quagmire of siloed islands, unified protection of enterprise data from a global perspective, and realization of full life cycle management; Growing data scale, data of different types and access frequencies dynamically match resources, properly store and manage it and incorporate it into the overall data management platform, these are all issues that enterprise IT needs to consider; The probability will form a cross-region, cross-local and cloud environment infrastructure resource pool. The data management platform needs to be able to support multiple sites, multiple modules, and multiple workloads, reduce complexity and optimize costs through global management.
By using an integrated solution, the CSV verification process that pharmaceutical companies must go through in their GMP compliance journey will be greatly simplified, and at the same time, the operation and maintenance management of digital assets will become easier and more sustainable. It can be said that the integrated delivery model that meets GMP compliance requirements and CSV validation has gradually become a popular standard for electronic data management in the pharmaceutical industry.
write at the end
The informatization construction of pharmaceutical enterprises has a history of many years. Although most pharmaceutical manufacturing enterprises attach great importance to the construction of informatization, there are still drawbacks, and the protection capability and level of data and information security need to be improved. However, as industry regulations become more and more stringent, the pharmaceutical industry is not only faced with how to "resist pressure", but also how to become more standardized and reasonable? Data management is essential, and data management should also be called the core driving force of the “internal driving force” and the hardest “underlying logic” in the pharmaceutical industry.
If the data is compliant, it will live, and if it doesn’t, it will die. Therefore, what can really help an enterprise must be a solution tailored to local conditions. Only by building a complete and unified data protection management platform in the long run can digital-driven business compliance transformation be implemented.
.jpg)
