In the context of this post, CSV is an acronym that stands for Computerized System Validation. [We will not be describing here other meanings of the CSV acronym available on the internet, such as: Comma Separated Variable/Value, Christlich Soziale Volkspartei, Collegium Studiosorum Veritas, Cocksfoot Streak Virus, Chrysanthemum Stunt Viroid, Catecholamine Storage Vesicles or Circumferential Shortening Velocity and others]. This post serves as an introduction to understanding what CSV is, what it entails and why is CSV interesting for the reader of this article. Furthermore, the interested reader can form a baseline knowledge of CSV for more posts to come in this blog.
What is a Computerized System?
According to PIC/S (ref.1), a computerized system is a combination of computer elements (hardware, firmware, software) along with the applicable operating procedures and people that control the computer system. This computer system can be linked to other equipment or instruments. The computerized system may further interact with other computerized systems, thus forming a networked operating environment.
Figure 1. A Computerized System
The GAMP5 guide is a thorough industry guideline that helps Life Sciences companies comply with industry regulations. Computerized systems are classified into four Categories according to the GAMP5 guideline (ref.2). Notice that Category 2 does not exist in the GAMP5 – it has been consolidated from the previous version (i.e GAMP4).
|1||Layered software, software used to manage the operating environment||Operating Systems, Anti-virus software, Network monitoring tools|
|3||standard product, no configuration, no customization||COTS software|
|4||configurable product||Data acquisition software, LIMS, CDS, ERP, MES, CRM|
|5||customizable product||Developed and customizable IT applications|
What is Validation and what is its purpose?
The third word in the CSV acronym is “validation”. Validation intends to provide evidence that something (i.e. a Computerized System in the case of CSV) always does what it is intended to do. This verification process can save time and money by discovering weaknesses or gaps in processes prior to going “live”. It can also increase product and system quality and finally, it can provide visibility of the risks associated with a specific process.
In the field of CSV the V-model is regularly employed as a guide to verify the user and functional requirements. The V-model is described in detail in the GAMP5 guide. Although CSV is used to validate computerized systems (initially or retrospectively) and to address audit findings, the ultimate goal of CSV is to provide confidence that the computerized system operates and performs as specified and also that it meets industry regulations. A Risk-based approach is beneficial to assess the degree of validation effort required.
Figure 2: Representation of the V-model
Where and when is CSV used?
All regulated organizations that use computerized systems to manufacture products for human use and in some cases for animal use must follow CSV principles at all times. This includes companies that produce pharmaceuticals, vaccines, biologics, food products, medical devices, nutritional supplement and even cosmetics.
In general, CSV principles must be applied if a computerized system is used for any of the following purposes:
- To manufacture, process, distribute, package or control a pharmaceutical product.
- To collect, analyze, or store data during production, R&D or clinical trials of a pharmaceutical product.
- To collect data that could impact patient safety or product quality.
- To provide information to regulatory authorities or other pharmaceutical companies.
CSV predominantly applies to the application level, from a User’s perspective. Currently though, the trend is that CSV principles are being used more and more in the development and supporting levels of an application as well (i.e. IT Development and Support Factory, IT Infrastructure, etc.)
Regulations and Guidelines relevant to CSV
The use of computerized systems in the Life Sciences must comply with certain regulations of Good [Manufacturing, Laboratory, Documentation, Clinical] Practices (GxP), so CSV principles must be applied in this case. The regulations under which a company operates and manufactures a product for human consumption or use must be followed. The United States FDA, the European EMA, the British MHRA, and Swissmedic in Switzerland are examples of regulatory bodies overseeing whether Life Science companies comply with current industry-specific laws. These groups inspect and audit life sciences companies frequently and regularly. A successful audit outcome can allow a pharmaceutical company to distribute their product to its customers, therefore providing confidence relating to patient safety and product quality. On the other hand, an audit accompanied by “observations” and “findings” may be catastrophic to the pharmaceutical business operations, sometimes including closure of entire manufacturing sites. GAMP5 and PIC/S referenced here provide guidelines to ensure an organization meets the industry regulations.
To summarize the relation between CSV and GxP, CSV must be used in all processes that are considered GxP within a Life Sciences company. However, CSV is not mandatory in processes that are considered non-GxP, although its use may provide benefits to the organization.
Why might you be interested in CSV?
For the IT professional who provisions business and technology consulting services in the Life Sciences field, understanding what CSV is about and also knowing when and how CSV principles can be applied, is an advantageous skill to have.
For the Life Sciences company and for people associated with one, applying CSV principles for GxP projects is highly recommended, if not a “must” nowadays. Due to increased internal resource capacity and in search of efficient new approaches to tackle problems, Life Sciences companies seek consulting expertise from external providers. Cambridge Technology Partners (CTP) is such a provider, and as an experienced business and technology consulting group, it has demonstrated it can extend its services into the CSV area providing solutions to large and mid-size Life Sciences organizations.
It has been known for some time now that the IT, Business and Quality groups within the Pharma environment must work together efficiently and productively to accomplish their common goals. It is also becoming increasingly evident that CSV is an integral part of achieving these goals and meeting industry regulations.
Service providers specializing in CSV act as facilitators within the relevant departments of a Pharmaceutical company and provide their expertise in order to:
- Help their customers achieve their validation goals and to benefit by employing CSV.
- Increase the chances of success during regulatory audits by enabling the customer to comply with industry regulations.
- Provide confidence that the regulated company’s computerized systems are doing what they are intended to do.
- Reduce costs for the customer and improve efficiency.
- Ultimately, play a role in improving patient safety, product quality and data integrity.
|CDS||Chromatography Data Software|
|COTS||Commercial off the shelf|
|CRM||Customer Relationship Management|
|EMA||European Medicines Agency|
|ERP||Enterprise Resource Planning|
|FDA||Food and Drug Administration|
|GAMP||Good Automated Manufacturing Practice|
|LIMS||Laboratory Information Management System|
|MES||Manufacturing Execution System|
|MHRA||Medicines and Health-care products Regulatory Agency|
|PIC/S||Pharmaceutical Inspection Co-operation Scheme|
|R&D||Research and Development|
Keep reading the CSV blog series with Part 2: Do you want to learn even more about it?
- PIC/S Guidance PI 011-3. Good practices for computerized systems in regulated GxP environments. 25 September 2007. (http://www.picscheme.org/pdf/27_pi-011-3-recommendation-on-computerised-systems.pdf)
- GAMP5. A Risk-Based Approach to Compliant GxP Computerized Systems. ISPE 2008.
Latest posts by Ilias Christodoulopoulos (see all)
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- ‘Have you heard of CSV?’ part 4. Suppliers of Computerized Systems in CSV. - August 6, 2015