If you’ve ever worked on a computer system validation project, you are probably acquainted with the new FDA’s Draft Guidance https://www.fda.gov/ on CSA ie., Computer Software Assurance.
There was an ambiguity raised by FDA once stated- “Due to the complexity of software, a seemingly small local change may have a significant global system impact. When any change (even a small change) is made to the software, the validation status of the software needs to be re-established.” As you can see the previous guidance expresses its ambiguity, which looks like FDA’s requirements for Validation almost not clear and unconfident. Since then, FDA has identified this ambiguity and come out to substitute CSV to CSA for Manufacturing, operations, and Quality system software which stressed more on “Critical Thinking” that should be part while implementation of Automated systems which is in FDA’s list for release in September 2020. To support the use of new technologies, FDA is drafting new guidelines “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” hoping CSA will tackle the issues that we have at this moment. In addition, FDA also intends focusing on Direct Impact systems and not on the Indirect Systems. In short, FDA clearly understood the importance of critical thinking assurance practices for industries. Now FDA is driving a clear shift from CSV to CSA. Now we will see the differences between Computer Software Validation and Computer Software Assurance- Differences b/w CSV & CSA Computer Software Validation (CSV) Computer Software Assurance (CSA) Regulations on use of Electronic Records and Electronic Signatures were framed in 1997 in 21CFR Part 11 and a revised version released in 2003 and for Eudralex, EU GMP regulations it is Annexure 11 (EME 1998). Regulations on Non-product Quality systems released in September 2020. Definition of CSV-Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. Definition of CSA- It is a paradigm shift from document focused computer system validation to critical thinking assurance practices. FDA’s CSV majorly focusses on documentation, testing, assurance needs, and critical thinking. New CSA model, focusses primarily on critical thinking and then on assurance needs, testing, and documentation. In CSV, Validate “everything” with the risk to miss higher risk functionality. Risk-Based assurance approach is the core concept by applying the right level of risk to product quality or/and patient safety. Spends more time on documentation for the auditor than testing which creates a notable compliance burden. Spends more time on testing than documentation. Ignoring previous assurance activity or related risk controls. Here, accountability is given to prior assurance activities and downstream/upstream risk controls. The scope of detection of software faults is less as it concentrates more on documentation than testing. The scope of detection of software faults is more as it concentrates more on testing activities than documentation. Applies to non-product quality systems. It might miss the higher risk functionality as it lacks conducting more testing activities. By having a targeted risk-based approach, it improves product quality, patient safety and data integrity. The US FDA originally aimed at Case for Quality initiative taken in the year 2011 at improving quality of medical devices and for patient safety https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality Bottom line The US FDA is providing new guidance that all the manufacturing industries and healthcare organizations should immediately embrace and understand the importance of CSA. This current transition from automated testing to risk-based critical thinking approach will eventually help us to bring patient safety and also improves product quality. Anticipating this new regulation, as foresight, Avanteva has already constructed A New CSA Approach for future needs. Reach out today !
A CRO (contract research organization) supports some of the life science industries like medical devices, biotechnology, and pharmaceutical industries as business outsourcing enter for services which include R & D (research & development) and clinical trials. The majority of the CRO’s are specialized in providing these services, particularly for clinical trials. One must function where the clinical trials would be successful is the documents accurately to be translated in the required language.
The CRO’s gaining huge work over the last few years as the complexity of drug molecule synthesis its production and development has led many pharma companies to outsource the clinical trials to contract research organizations. Statistics say, in the year 2011, the CRO outsourcing services were used by 27% of top pharmaceutical companies and 47% of small-sized companies. 33 out of 38 drugs approved in the same year were tested by CRO’s. Countries, where clinical trials are performed, have their own set of regulatory guidelines and the approval procedures. For trial submissions to be approved in global countries, documents like the following patient informed consent form, clinical summary reports, and many others may have to be translated into their local languages. For instance, a clinical research organization that chooses to launch their product in Europe many have to translate into more than 23 languages of the European Union. Hence, this translation business is a large responsibility and the sponsors will be contacting CRO’s for this task thus, in turn, they contact the translation service providers. Avanteva solutions POPC Pvt. Ltd is expertise in translating these documents. We translate the following Clinical documents for Clinical companies under Clinical Trial and Research- Informed Consent Forms (ICF’s) Clinical trial protocols Patient surveys and diaries Case Report Forms (CRF’s) Investigator Brochures Adverse Event Reports IRB/IEC documentation Patient Reported Outcomes Forms (PRO’s) Patient recruitment materials New Drug & Marketing Authorization Applications Patents and Contracts Pharmacology & Toxicology Reports Ready to ensure your clinical documents meet global regulatory standards? Connect with our expert translation team today and discover how we can support your clinical trial success across multiple languages and markets.
Most of the industries use translation service for their daily operations. With their growth in the business, they had to find a right translation agency that will be capable to meet their requirements and follow timely submissions.
In this article, the author explains the criteria to choose the best Translation service provider in the translation business. The following are the recommendations suggests considering a perfect translation service provider for your documents:- Decide your requirements at the start Check the Qualifications/experience of the translator Go always with Certified Translators Find native speaking/local translator for the target Language Pick a Translator for your suitable area Customize the process for every project Translation management and the procedures Confidentiality Insist for a timeline for submission Plan above steps and implement 1. Decide your requirements at the start This is the primary step to start finding a right translator for your documents. Examine and list out all the requirements for your business. Any particular text that needs to be translated has a level of significance of its own. The accuracy of the documents translated plays a crucial role. Discuss with your project management team and decide the budget, amount/type of documents to be translated and the language to be translated. “A contract made between the translation agency and the client will get the pricing fixed for a standard number of years.” Highly qualified translations will usually cost a bit more but remember that it is worth investing as you need the best results. Learn and decide the importance of quality and accuracy of the translation to you. Do not get compromise with the quality. This will benefit you to a greater extent when you look for a translator, because not all translators are created equally. 2.Check the Qualifications/experience of the translator A translator should be aware of the linguistic rules of communication like mastery of spelling, proficiency in grammar, understanding syntax. One needs to check the Qualifications and experience in the field of translation before you start the project. You can contact us to know more about our translators or just email to translation@avanteva.org 3.Go always with Certified Translators In the outside market, you may find many translators but you must choose a qualified translator. If you ask us we will be able to show the certifications as evidence to understand their abilities and area of expertise. 4.Find native speaking/local translator for the target Language As you know, translators work from a foreign language into their mother tongue. If you need a translation in Hindi, for example, you need a Hindi native who speaks English and translates from English to Hindi. It’s always better to choose someone whose native language and target language are the same. 5.Pick a Translator for your suitable area Translators should have a very good command of the language and also needs technical expertise in their field of work. Here at our company, we have translators who are specific for every field like Clinical, medical, non-clinical, or general translations. An approach that is suitable for all shall not serve the purpose. So, pick a translator that works for you. 6.Customize the process for every project Based on the client requirement, we customize our services accordingly. We do Forward and Back translation, for example first translating source (English) into the target (Hindi) and then the target language (Hindi) back into source language (Hindi) using different translators. Lastly, we compare both versions and work on any discrepancies or wrong translations. This is a robust method we carry out in general as part of our service. Along with these procedures, we also take up Proof Reading. Once the translation is done by the translator, we make sure that the text (assumed to be the final PDF copy that reach the target audience) is rightly proofread. This is performed by a third person other than the translator. This step ensures high accuracy of the translation and eliminates the possible errors that might occur before it reaches the intended audience. All the above inclusions may cost a bit but gives 100% accurate translations. Therefore, we highly recommend these procedurals on a routine basis. 7.Translation management and the procedures Our company has standard protocols for Translation management procedures. All the translators are well trained and instructed to implement the constructed procedures without fail. And we show continuous efforts to make sure that translation is happening in the right manner. For that, our Project Management Lead supports the smooth running of every project that been taken up. 8.Confidentiality Ask about the procedures a translation service company takes that guarantees the confidentiality of your document. Our company provides signed confidentiality agreements for special projects. 9.Insist for a timeline for submission We highly ensure to submit the translated documents within promised stipulated timelines. We understand the urgency of your operations. But be aware that urgency is not always synonymous with quality. To speed up the process, we distribute the work to different translators for different steps like back, forward translations, editing, proofreading etc,. This helps us to obtain homogeneous results without errors. 10.Plan above steps and implement Make a checklist to ensure that all the above requirements were met without any scope of errors. We believe “Failing to Plan is planning to fail”. So plan at every step to achieve the best end results. Conclusion: Companies (customers) hence need to be more careful in choosing the right translation company to set their work standards and their projects. Establishing best practices and make sure to implement the same shall be mandatory. Along with improving the subject matters can reach a large way for outpouring qualitative outcomes.
