CSA (Computer Software Assurance) A move from Traditional CSV

FDA’s Draft Guidance on Computer Software Assurance for Manufacturing, Operations and Quality System Software has emphasized on ‘Critical Thinking’ to be a crucial part while implementation of automated systems. In brief it is a paradigm shift from document focused computer system validation practices to critical thinking assurance practices. The industry and the FDA are driving the shift toward computer software assurance (CSA).

Traditionally, FDA’s CSV (Computer System Validation) focuses on documentation, followed by testing activities, assurance needs, and critical thinking. Whereas, in the new CSA model it focuses first on critical thinking and then on assurance needs, testing activities, and documentation

CSA Approach:

  • Critical Thinking: Risk definition for each Software Features
  • Assurance: Demonstrate if the feature & functionality is working as desired
  • Testing Activities: Leverage and define the different test methods like Scripted and Unscripted testing

The new FDA guidance intends to focus on more testing and considerably less documentation. Let us have a brief overview of the FDA’s CSA approach for Scripted and Unscripted testing.

Testing Activities – Scripted and Unscripted Testing:

When we go by the definition of Unscripted Testing, it is a type of software testing in which the tester is free to select any possible methodology to test the software. As per the typical definition of unscripted testing, software developers / Testers use their skills and abilities to test the software developed by themselves.

Let’s take an Example of Scripted and Unscripted Testing:

When we consider of LMS (Learning management software) and applying critical thinking

  • Training need generation, Training Session management can be considered as unscripted testing.
  • The scenario wherein a production executive working in critical area has been failed 3 times in the certification, the executive should be automatically barred from entering the production areas. Since, this has an impact on product quality, we need to check this feature as high risk and must need to execute the proper test script and record the evidence. This scenario will be considered as scripted testing.

During unscripted testing there is always a possibility that few scenarios are missed by the Developers / Testers. So, performing Unscripted testing during the Requirements Phase involving the Business User’s will makes Developers / Testers to test the features, allows them to think more logically and help in adding them as new and required features. To achieve the assurance of such software features, imagine the adoption of LOW CODE PLATFORMS and applying Critical thinking and Unscripted Testing

AmpleLogic Implementation Model: Adoption of Latest Technology Trends

FDA is proposing the adoption of the Smarter Techniques in Software delivery. Research firms like Gartner Predicts that by 2024, low-code application development will be responsible for more than 65% of application development activity

LOW CODE PLATFORMS:

Low-code Delivery approach helps organizations deliver software as efficiently by maximizing reuse and minimizing the need for hand-coding. Freed from the complexities of low-level implementation details, teams can focus on high-level, strategic work that adds business value – with increased creativity and collaboration.

Imagine a situation where business User dictates user stories and the Software service provider develop the software on the fly. The adoption of LOW CODE delivery approach will add value to the CSA Approach.

How Low Code Platform can help you achieve the CSA approach bypassing the Traditional Software service model?

CSA Approach

Drag and Drop visual Modelling:

FDA’s CSA approach emphasis on identifying feature, function and operation for the automated system that directly impacts patients or product quality. With Low Code visual modelling the business users can experience the software and are able identify the areas in the process that have direct impact on product quality. Using the Drag and Drop functionality service provider will configure the application and the business user will experience the working functionality. Low Code platform’s ability to breakdown process, workflow, data set, etc. into smaller bits and pieces allows business users to use critical thinking to streamline assurance activities and capture evidence of the processes

Configuration and Experimentation Approach:

The Configuration and Experimentation approach helps in critical thinking and expanding the boundaries of what the software can do. It makes you think more logically and helps in adding more and more required features and functionality. Applying the Configuration and experimentation approach in CSV will also lead to similar outcomes of CSA.

User Requirements

During the assurance phase if the business user’s expectations can be demonstrated by the service provider, then business users can think more logically and add missing system requirements. Following, the high-level system requirement of the business users the service provider can use unscripted testing to identify new features.

“Configuration and Experimentation” of the User Requirements combined with visual modelling (Drag and Drop) Techniques the software service provider along with business users can help us to move toward less documentation, minimizing the validation time and follow the risk-based approach.

Conclusion:

Enhanced Critical thinking + Assurance + Testing Activities (Unscripted Testing) can be achieved thru Configuration and Experimentation while using LOW CODE Development Platforms.

CSA will reduce the Testing and documentation efforts. Following CSA with Low Code Development Platforms and applying Configuration and Experimentation approach will further help in visualizing the software during Requirements Phase itself, reduces the time to deliver.

AmpleLogic has been delivering Services in GMP digitalization with their solutions like Quality Management System (eQMS), Document Management System (DMS), Learning Management System (LMS), QC Planning, Electronic Log Book (eLogs), alongside with other 20+  custom solutions for Biopharma, Pharmaceutical, medical device and related industries. AmpleLogic recognized as Finalist during CPHI Worldwide 2018 Awards for reducing the Validation cycle times with their innovative delivery model.

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eQMS

Root Cause Analysis with example for “5” Why technique

Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in the quality process to get to the “root cause” (actual cause of origin) of the non-conformity. RCA helps to correct or eliminate the cause and prevent the problem from recurring (preventive action). Root cause analyses is aimed at improving products or processes quality and must an in systematic ways to be effective. Different Methods of doing Root Cause Analysis: Root Cause Analysis Methodology   Fish bone technique The “5” Why’s technique. Barrier Analysis Change Analysis Casual Factor tree analysis Failure mode and effects analysis Pareto analysis Advantages: To identify non-conformity and the causes, so that permanent solution can be found. To develop a logical approach of problem-solving, using data that already exists in QMS (Quality Management System) To identify current and also future needs for organizational quality improvement. To establish a repeatable systematic step by step processes, in which one process can confirm the results of another with deep analysis. Challenges: Not having the ability to understand the problem and therefore not defining it correctly. Not considering all possible failure modes. Not able to identify all root causes. No proper defined solution for the non-conformity. The “5” Why technique causes mapping Non-conformity identified: Decrease in the viscosity of Vitamin D3 syrup. The “5” why technique can be expanded to 15 why or 150 why the deeper you go the more thorough analyzing takes place and reveals better solutions Contact us for more information about the AmpleLogic Quality Systems Offerings.   Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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DMS

Why is embracing the Document Management System still intimidating?

DMS in a layperson perception A thorough-cum-simpler explanation of Document Management System will make us understand about the efficacy of this digital trend. With the name “Electronic Document Management System”, we get an overall idea that the system is supposedly managing the documentation process. Now, this process is the common one being done in every organization, we all know. Here the point comes is : How are these documentation things being processed or managed in various industries these days? Collecting all the needed data or information of a company and putting them down in a specific file or document is something that we know very well, which has been done manually for ages. But with trending technological inventions like IoT, AI, Cyber Security, etc., in the ongoing digital world, we must step up to a more effort-less mode of documentation. 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On incorrect data feeding, mismatch of information, missing data, you will get a reminder or notification which is not possible in manual management. All the data is stored in a specific and common cloud, which is accessible to everyone from everywhere. A smooth documentation now ensures a streamline workflow and saves a lot of time and resources which can be used in other areas of growth. Complete replacement of paperworks into paperless documentation becomes easy with eDMS. Having thorough data on drugs, research, new compliances, regulations require error-free documentation and with Pharmaceutical Document Management Solution this task can be managed easily. Storage of all the digital documents under a common cloud is much safer than keeping manual data in the form of documents stored in some physical storage. Accessible cloud storage documentation allows you to access the data whenever and wherever required, whereas in manual management there is some chance of missing out on important data. An organized documentation not only takes care of the data storage but also ensures a smooth flow of additional departments like SOP Management, manufacturing, operation, quality planning, etc. Terrorizing reasons restricting full-fledged eDMS inculcation Despite a lot of benefits, there are many companies who are reconsidering their decisions of incorporating Document Management Systems into their business. Every innovation comes with certain pros and cons. When we have already understood several benefits of the automatic documentation process, let’s explore the risky or stressed side or probable challenges of this digital trend. Data being vulnerable: With documentation being staged on digital platforms, it is extremely necessary to keep an eye on the security side. When crucial data is stored in the cloud then there comes a major terror of data being vulnerable and being attacked by malicious cyber frauds. Hence, it is required to maintain utmost cybersecurity ensuring the documentation is safe in the cloud kept away from cyber thefts. Doubt on successful implementation: There are so many growing features of Electronic Document Management and Tracking Software for Lifesciences industries, but we need to explore all those specifications accurately. Adding on a digital trend to a business could sound fun, but the real game starts when you implement the software effectively. This can be done with active seminars, group discussions, and taking feedback from employees (who are using it) on document management solution. Fear of smooth integration: The DMS must come up with appropriate integration of all relevant departments, then only we can assure its potential usage. Hence integration of DMS with other in-house applications must be done properly to make the system work automatically and independently. Staying inconsistent in usage: To replace paperworks with digital paperless ones, giving employees detailed training on Pharmaceutical Document Management and Tracking Software is essential. Hence, keeping the usage of DMS consistent becomes a tough task if the users are not well-trained. So, the prior task is to train employees about the usage of the platform and bring consistency in keeping the system in work consistently. Realising the probable challenges as well as conquered benefits of Document Management Solution we can easily understand how to proceed with this amazing transformation from loads of paper-based documents to hassle-free paperless one-stop-data centres. AmpleLogic’s best DMS software is assisting several pharma as well as other businesses to successfully implement this amazing digital tweak to their work processes making lives easier. Talk to our team to enroll for a free demo on Electronic Document Management System. 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LMS

Benefits of Training Management System

Here’s what a Training Management System can, and should, do for you: Learning Management System makes it very easy for trainers to update existing training content or add new content in a short time Comply and Meet essential regulatory requirements and other best practices more easily Enhance managers and employees ability to achieve required results, not just complete the training Measure the reduction in operational expenses, travel time and on-site visits Reduce the time for needed for creating, updating, printing and shipping of learning course manuals and documentation Dramatically reduce the cost of software for managing and creating training courses Improve the administration of your learning programs Increase your ability to manage and deploy e-learning to your employees across any location Consolidates training information to improve efficiency, improved facilities coordination and cost utilization Improve personnel performance by enabling you to manage admiration and human resources more effectively Implement more and more effective skills and competency training management programs Reduce training costs Increase the number of training courses that you can deliver for less money Training Course materials on an effectively deployed Learning Management System (LMS) can be accessed by employees across geographies, without affecting the quality or consistency of training These training systems allow the creation, personalization, and download of detailed training reports outlining the progress of the learners, departmental groups, completion of work, time taken to complete the task, etc. which allows easy evaluation of their progress either as an individual or a group A modern Learning Management System, like AmpleLogic LMS, can support your organizations as it grows, and give you the flexibility to add the latest features and functionality to support your training and learning programs Are you ready to invest in a new Learning Management System or LMS? Contact us today to find out more or schedule a demo. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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