It's a must: companies in the pharmaceutical and medical technology sector are obliged to introduce validated software and adhere to strict compliance rules. Computer systems used for the production, testing and documentation of sensitive products such as medicines must provide accurate and reliable data. There must be no room for deviations; after all, the goal is maximum patient safety.
Strict requirements from supervisory authorities
In software-supported production, for example, the dosage is calculated automatically. The slightest error can lead to products being faulty, deviating from the strict standards and posing a risk to patients. Regulatory authorities such as the FDA (Food and Drug Administration) and the EMA (European Medicines Agency) therefore stipulate requirements that must be met in software-assisted manufacturing.
Computer system validation as a factor for business success
Computer system validation can bring considerable benefits for your own company. Safe, high-quality products ensure satisfied customers and avoid complaints. You avoid unnecessary costs for complaint processing, promote your company's image with high quality standards and avoid legal consequences â setting the course for long-term success and growth.
However, in order to achieve the desired security, conformity with the applicable regulations and the desired quality, you must first successfully complete the computer system validation process â and this is where challenges lurk that can become stumbling blocks if approached incorrectly.
The four biggest challenges of computer system validation
They underestimate complexity of strict regulations.
Typical standards such as GxP, 21 CFR Part 11 and EU GMP Annex 11 regulate the requirements for computer system validation. Anyone who deals with them quickly realizes that they are extremely comprehensive and are adapted at regular intervals. This is important and right, because the products in question are sensitive. But patients will only receive safe products if the specifications are taken into account in every detail and implemented accordingly.
They do not have sufficient expertise.
In-depth expert knowledge and a suitable project methodology are required to fulfill the technical and regulatory aspects of computer system validation. Only very few companies have both, which usually leads to delays and an increased risk of errors. You run the risk of losing valuable time, which you do not have in a contested market with numerous competitors, and risk the quality of your products.
They are under great cost and time pressure.
Strong competition and turbulent economic times are putting companies under increasing pressure to bring products to market quickly and cost-effectively. The idea of going through the validation process with less precision or shortening it is an obvious one. This can have an impact on the quality of your products, patient safety and ultimately the reputation or even approval of your company.
You want to validate software in the public cloud.
Successful validation of a computer system means that it fulfills its intended purpose consistently and reliably at the time of testing. In the event of an update, there are naturally changes that need to be tested and approved again. The execution of these periodically recurring tests therefore requires good planning so that they run routinely in the case of updates and can even be supported by automated tests if necessary.Â
4 tips for successful computer system validation
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With experienced experts, you can go through the computer system validation process purposefully, successfully and safely.
The best way to bring professional knowledge to your validation project is with an experienced partner. Based on the practical experience of numerous projects, the necessary specialist knowledge and a suitable methodology, you will master computer system validation safely and purposefully. You use a software solution that reliably meets all requirements, paves the way for innovative products and drives your company forward.
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A risk-based approach ensures compliance with less complexity.
Experienced validation partners use a risk-based approach to reduce the complexity of the processes to be checked while maintaining full compliance and safety. Instead of checking all processes equally, the focus is on the critical areas that have a direct impact on product quality.
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Regular training courses build up internal skills.
To ensure that the internal understanding of the requirements of a validated software solution is covered, regularly train the people involved in further training courses. To cover all aspects, this training should include both technical and regulatory aspects.
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Special approach makes computer system validation in the public cloud a successful project.
With the right approach, computer system validation in the public cloud also becomes a successful project. Using a cloud strategy, you can work with the right partner to implement your ERP system in the public cloud in a compliant and validated manner and meet the requirements of EU GMP Annex 11 in the long term.
This ensures that computer system validation runs smoothly and reliably.
We are YAVEON, experts for the pharmaceutical and medical technology industry. As a Microsoft partner, we have been advising and supporting companies in the pharmaceutical industry with successful computer system validation since 2008. With experience, best practices and all the necessary documentation, we provide them with a way to safely introduce our centerpiece, the industry ERP YAVEON ProBatch. With success! Our solution is already in use worldwide with over 750 installations. ProBatch is not only fully integrated into Microsoft ERP Business Central, but also includes everything that a suitable pharmaceutical or medical technology solution needs:
Our team consists of over 230 hard-working people who are passionate and dedicated to the success of our customers. Because companies in the process industry that choose YAVEON expect more than just practical functions. They get a solution of the highest quality, industry-specific advice based on years of experience and best practices, and a long-term companion.
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