December 14, 2015
Computer System Validation (CSV) requirement has not received much attention as part of regulatory compliance process by many Southeast Asian companies. This is an often-neglected aspect, which is addressed much later in the product development and commercialization processes by the companies. However, lack of early preparation while moving forward regulatory compliance in line with GxP guidelines can be costly.
The negligence is often due to the lack of awareness about when and why one should invest in CSV.
In principle, all pharmaceutical, biotech, medical device, food, and cosmetics companies that deal with products for human or animal use need to follow CSV principles. The involvement of the company can be related to various relevant activities in the value chain including R&D, clinical trials, production, QC, distribution, and packaging, if a computerized system is used in any of the activities involved.
Importance and Impact of CSV for Life Sciences Companies
“Computer System” refers to desktop systems, client-server systems, laboratory system, data acquisition system and associated software and also system supporting documentation. The Computer System Validation (CSV) must ensure accuracy, reliability and should be able to detect invalid or changed records. In this context Computer System Validation is not only crucial to satisfy the regulatory compliance requirements but also to ensure good business practice and ethics are followed.
The main goal of CSV is to demonstrate the conformance to system requirement specification so as to avoid high maintenance cost in the event of a recall or corrective measure at a later stage after product release to market. This can be achieved only:
- Ensuring control, maintainability, and traceability at all stages
- Demonstrating the credibility and suitability of computer systems to perform with high level of accuracy and reliability
Since life sciences companies are involved in the businesses that have significant impact human lives, it is mandatory to follow the regulations as per the guidelines of GMP, GLP, GCP, etc. CSV is mandatory for all processes that are considered GxP for registering with international regulatory bodies such as USFDA and EMA. Even though for certain processes that do not fall under GxP, CSV requirements are exempted, compliance offers advantages to companies.
How AcuBiz can support in your CSV Process?
In the race to become the first in the market with cutting edge technology and innovative solutions, companies are under tremendous pressure both in terms of time and resource availability. Even though it is important to avoid any regulatory compliance issues, allocating internal human resources for CSV can be costly as CSV tasks are highly involved and time-consuming. Most companies opt to outsource these tasks so that core business activities are not compromised.
AcuBiz team is capable of offering valuable assistance to its clients by supporting them in CSV and related regulatory documentation. The salient features of our CSV solution framework include:
- Base lining and Gap analyzing: To collaborate with multiple stakeholders such as regulatory experts and test managers to quantify the risk, strategize, and prioritize for validation
- Domain-focused computer system validation in line with GxP, 21 CFR Part 11, and GAMP5
- Creation of templates based on FDA guidelines and SOPs, checklists and forms
Our team ensures minimum time and effort from clients while confirming that there are no “regulatory surprises“ during a product launch. We evaluate the risks of regulatory impact and probability as per the standards to assess computer systems.
By offering flexible, domain focused and cost effective CSV offerings, we assist pharmaceutical, medical devices, food, and life sciences companies to achieve CSV in line with their regulatory compliance requirements. This is the CSV symbiosis that AcuBiz envisions..!