In order to ensure that computer systems work in the way anticipated by business managers, regulatory agencies usually require a validation process be set in place. Ignoring this step might result in datum corruption, compromise to its integrity, risk for the company’s clients, and a lower level of trust.
Implementing Computer System Validation requires guidance and in-depth knowledge. If you’re wondering whether or not CSV is required for your company, what benefits you could get from it, and ways to handle such an operation, this blog will provide answers to all of those questions.
Table of Contents:
- What is CSV in Software?
- Who Needs Computer System Validation?
- Computer System Validation in the Pharma Industry
- Computer System Validation Process Checklist
- Computer System Validation Examples
- Computerized System Validation (CSV) with PFLB
What is CSV in Software?
Before getting into the meaning of CSV, it’s crucial to understand how the Food & Drug Administration (FDA) and other regulatory bodies define computer systems. For starters, business managers need to broaden the scope of the term beyond a PC and the software suite installed on the device.
Computer systems include all the complementary equipment that supports the system as well as its users as a whole.
In software, CSV is perceived as a method that allows business managers to successfully complete the tasks a system was designed for, have control over user operations and their security, and be legally compliant.
The list of CSV activities usually consists of:
- Specifying user requirements;
- Defining functional requirement specs;
- Creating a Validation Plan;
- Writing Operational Qualification (OQ) Scripts;
- Maintaining system release documentation.
This is not a definite list of operations that fall under the term of Computer System Validation. The range of activities heavily depends on the company’s profile, scale, and the market where it operates.
Who Needs Computer System Validation?
Computer System Validation is more than a way to avoid profit loss and business risks. In certain instances, it can be life-saving.
For instance, detecting medication defects can prevent unfortunate side effects and avoid significant damage a drug consumer would’ve otherwise received.
That’s why CSV is an obligatory stage for some companies. Here’s the list of businesses that are legally enforced to conduct Computer System Validation.
- Pharmaceutical companies. In the US and most developed companies, pharmaceutical businesses have to undergo CSV. In particular, you need to validate your system if your business produces or distributes drugs used for diagnosing or treating diseases.
- Storage and distribution providers. Businesses that store pharmaceuticals, biologicals, or cell-and-tissue products are obliged to complete CSV. Otherwise, the penalties might be as high as debarment or a criminal prosecution.
- Products that sell biologicals. A product can be defined as biological if it’s made from a therapeutic serum or a virus and used for injury or disease prevention and treatment. Vaccines are biologicals too.
- Medical devices distributors. By definition, medical devices comprise of any instruments used for diagnosis, treatment, or prevention of illnesses. The most common examples of such are lasers, medical implants, tongue depressors, thermometers (only medical), and prosthetics.
Computer System Validation in the Pharma Industry
A pharma business manager needs to keep in mind that CSV is an industry standard accepted on the international level. In the US, the Food and Drug Administration is the main regulating and controlling body. It specifies computer system validation guidelines and monitors companies’ compliance with the norms.
For EU-based companies, validating the CSV software used by medical devices is a must as well. It is regulated and normed by the EudraLex Volume 4 — in particular, Annex 11 on Computerized Systems.
International healthcare protection organizations also keep a close eye on the process of Computer System Validation. This is monitored by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Uses (IHC) and the World Health Organization.
The range of benefits CSV brings to the pharma industry is quite broad.
Validating computerized systems helps establish a fixed order in which companies manufacture drugs or medical devices and distribute them.
CSV improves the efficiency of handling unexpected complications as well as the overall performance of the system.
Namely, the benefits of CSV in the pharma industry go as follows:
- Legal compliance with the FDA — after completing Computer System Validation, companies will be able to provide regulatory organs with all the needed documentation;
- Reduces compliance risks. Having empirical evidence of the fact that the system works as expected comes in handy during the inspections from regulatory organs.
- Discovers defects before a system build goes live. This way, pharmaceutical companies can avoid image losses or fraud.
- Provides companies with continuous improvement. Validation is a necessity for companies that constantly scale and add new features as it allows the development team to prevent tech debt from piling up.
- Maximizes system efficiency. If companies have validated systems, a business manager increases its future value and the efficiency of employers that use it. In the long run, CSV reduces both operating and labor costs.
Computer System Validation Process Checklist
As a rule, CSV is a multi-stage process.
Usually, while validating computer systems, companies stick to the Good Automated Manufacturing Practice V-Model, also known as GAMP-5.
It is built in a way that ensures there’s a quality check after each validation stage. Let’s take a look at the step-by-step breakdown of Computer System Validation.
- Planning — at this stage, a company manager establishes the deadlines and the budget needed to carry out Computer System Validation. Also, all stages are broken down by time and monetary estimates.
- Defining user requirement specifications. Basically, this includes all the functions a system needs to carry out.
- Design specifications. At this point, a team involved in CSV decides the look of a given function and the way it should function in order to complete all tasks outlined during the previous stage.
- Configuring a system build. This stage consists of writing configure scripts that will design the software for a computer system.
- IQ tests. A testing team runs a range of scripts to determine if they have chosen the correct way to install the system into the user environment.
- PQ tests — a CSV engineer has to test worst-case scenarios to ensure a system would still work properly under poor conditions.
- Reporting. All planned activities are reviewed. A tester has to document the result of validation and organizes them as proof that a system is ready for release.
These are the main steps of the computer system validation that would help testers get a reliable outlook on the hardware and software that has been assessed.
Computer System Validation Examples
To get a better understanding of which systems should be validated according to the law, let’s take a look at the FDA-backed list of computer system examples.
- Control systems. The technology stack of modern control software is extremely broad — there are sequential function charts, function blocks, ladder logic, and so on. That’s why it’s wise to use a matrix-based documentation system to validate such systems.
- Clinical, laboratory, or manufacturing database systems. Now, when the use of wearables to collect medical data is almost commonplace, there’s a lot of data systems have to manipulate and store. That’s why validating database systems requires constant innovation. The good news is, there is no lack of disruptive CSV practice. A group of Japanese scientists, for instance, has suggested a way to validate clinical database systems that use wearable by creating a custom data-flow model.
- Manufacturing execution systems. MES is a dynamic environment — that’s why, during validation, developers pay extra attention to assessing the performance of its workflows. Manufacturing execution systems are often tested by the configurable manufacturing models. A CSV engineer has to assess and approve of alternate paths, step-by-step operator procedures, dispense specs, and so on. The validation process has to enforce the security and compliance of an MES.
- Laboratory data capture devices. Validating data capture systems, testers rely heavily on Good Automated Laboratory Practices and the National Environmental Laboratory Accreditation Conference.
- Automated laboratory equipment. The process of automated equipment validation consists of quality control checks, sustainability tests, the validation of analytical methods, and the qualification of analytical instruments.
Computerized System Validation (CSV) with PFLB
At PFLB, we have created an automated CSV solution that pharmaceutical businesses and healthcare service providers will benefit from. After validating your computer systems, you will not have to worry about legal liabilities with GMP, Annex 11, ISO, and FDA regulations.
By reaching out to PFLB for computer system validation services, you will be able to:
- Reduce the amount of effort needed to release the build as well as the operating costs;
- Identify best practices for system management and streamline them across all systems that are subject to legal regulations;
- Have ready-to-go documentation that will come in handy during an audit;
- Simplify and streamline the QMS’ and lab information management systems’ validation process.
- Manage computer systems proactively, being able to predict risks and reduce their negative impact on the system.
A business manager can always count on our team of high-class lab information technologists — we will answer all of your questions, provide advice, and share best practices we’ve collected through years of working experience.
Computer System Validation is crucial for a healthcare company’s lifecycle as it is an integral part of your business’ legal compliance.
Other than being a standard requirement, it provides the entire team with a better understanding of the system and insights on ways to use it to the fullest extent.
Computer System Validation will only be fruitful if performed by a professional team. If you’re looking for a trusted team that will take care of all CSV aspects, contact PFLB. Take a look at our Computer System Validation services to get a better idea on how we can contribute to your project. To discuss a CSV project, contact the team — we look forward to a fruitful collaboration!
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