DMS
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. So, with this, we came up with eDMS.  Replacing manual documentation work to automated-cum-electronic documentation, Electronic Document Management System has brought a different level of changes in contemporary pharma as well as life sciences companies. A quick peek of digitalization using Electronic Document Management Software (eDMS) While DMS has given us chances to ease our pain with an effective modification in documentation tasks, FDA’s 21 CFR part 11 has confirmed that electronic documents along with the records and signatures can surely be considered as the legitimate ones. Hence, it has confirmed that there will be no difference between paper signature and e-signature, rather the later one will be more considerable. Let’s have a quick walk through the benefits we have gained with Electronic Document Management System in contemporary pharma companies. Easy creation, management, and storage of all the crucial data and information of the company is possible with DMS. 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. 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

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Top 9 Challenges and Solutions for eDMS Software in Pharma Industry

The pharmaceutical industry operates in a highly regulated and complex environment, facing numerous challenges that can impact productivity, compliance, and overall efficiency. Managing documents from several sources becomes challenging and time-consuming. However, eDMS Software is a power-packed electronic document management system exclusively designed for Pharmaceutical and Biotech companies, developed, and implemented exclusively to meet the cGMP needs of the Pharma domain with 21 CFR Part 11 compliance, EU Annex 11 compliance can easily eliminate all the challenges faced by different companies. Below are the few regulatory bodies that offer guidelines for generating, handling, and maintaining the journey of a drug development process. However, the electronic document management system (eDMS) has become a game changer in today’s era. It is vital for the smooth functioning of the pharma operation in today’s complex and collaborative work environment. Simultaneously, eDMS addresses the challenges faced by the pharma industries in the recent scenario. In this article, we deep-dive into some of the most common issues faced by the pharma industries. eDMS paves path for transformative change In recent years, the pharmaceutical industry has witnessed a significant transformation driven by advancements in technology. This digital solution has been instrumental in streamlining processes, improving efficiency, and ensuring compliance across the pharmaceutical sector. No doubt it has become a game-changer by enhancing document control, improving regulatory compliance, enabling efficient information retrieval, ensuring data security, and streamlining audits. As a result, eDMS empowers pharma companies to operate more effectively in a highly regulated environment and like SOPs, Protocols, Specifications Annexures and more. As the industry continues to evolve, eDMS will continue to play a crucial role in supporting innovation, collaboration, and overall success in the pharmaceutical sector. Moreover, the eDMS can be integrated with pharma electronic quality management software and digital learning management systems due to its robust document control capabilities, designed to manage documents more effectively and efficiently while ensuring compliance with all the applicable regulatory requirements. Also, the Software can incorporate various document formats. Types of documents that can be uploaded in the DMS Software Key Pharmaceutical Industry Challenges & Solutions of eDMS Software eDMS has come a long way and overtaken paper-based traditional systems as part of the shift towards greater transparency, making data increasingly searchable, accurate, easy data sort, store, retrieve, archive, and difficult to forge. Let us now have look at how eDMS solves the issues faced by the pharma industries: 1. Document Accessibility from Tab, Mobile, or Web Browser: eDMS platforms are designed to provide seamless access to documents from various devices, including tablets, mobile phones, and web browsers. With responsive web interfaces or dedicated mobile applications, authorized users can conveniently retrieve, review, and collaborate on documents regardless of their location or the device they are using. This feature enhances workforce mobility, facilitates remote work, and promotes efficient decision-making. 2. Mandatory Review based on Knowledge Gained on LMS Content: Integrating eDMS with Learning Management Systems (LMS) enables a streamlined process for mandatory document reviews. When employees complete training or gain specific knowledge through the LMS, the eDMS Software can automatically trigger document review assignments based on predefined criteria. This integration ensures that personnel with relevant expertise or newly acquired knowledge review and validate documents promptly, improving compliance and reducing delays. 3. Print Controls, Additional Copy Prints, Reprints: eDMS Software offer robust print controls to manage document printing within the organization. Administrators can set permissions and restrictions on printing, limiting the number of copies, and controlling who can print documents. This feature helps prevent unauthorized distribution of sensitive information, reduces unnecessary printing costs, and ensures that only approved printed copies are generated, eliminating the risk of outdated or uncontrolled prints. 4. Issuance of Documents (Controlled Copies, Drafts, Uncontrolled Copies, and Training Copies): eDMS facilitates the issuance of different document versions and types as per the defined requirements. Controlled copies, which are official and approved versions, are securely stored within the eDMS repository. Drafts allow for collaborative editing and review before final approval. Uncontrolled copies are made available for reference purposes, typically with restricted editing rights. Additionally, eDMS can manage the issuance of training copies, ensuring that the latest version of documents is available for training purposes, maintaining consistency and accuracy. 5. Reconciliation of Issuance: Reconciliation of document issuance is a critical process to ensure that the right versions of documents are distributed and accounted for. Hence, it simplifies this task by maintaining a centralized record of issued documents. It tracks the issuance status, identifies discrepancies, and provides real-time visibility into the location and status of each document. This reconciliation feature helps eliminate errors, minimize the risk of non-compliance, and ensures accurate documentation throughout the organization. 6. Version Management to Avoid Deviations on Timely Management of Versions: eDMS platforms excel at version management, ensuring that the correct document versions are used throughout the organization. By maintaining a clear version history, eDMS enables easy identification of the latest approved version and highlights any deviations or outdated versions. Notifications and alerts can be set up to inform users when a new version is available, minimizing the chances of using incorrect or obsolete documents. This feature promotes compliance, reduces errors, and fosters adherence to standardized procedures. 7. Watermarks: eDMS Software provide the option to add watermarks to documents, enhancing document security and control. This feature helps prevent unauthorized distribution, discourages unauthorized modifications, and maintains document integrity. 8. Change Control Integration and LMS System Integration: eDMS platforms often integrate seamlessly with change control systems and LMS systems. Change control integration ensures that any changes made to a document, such as revisions or updates, follow a defined change control process, allowing for proper review, approval, and documentation of changes. Integration with LMS systems ensures that employees have access to the latest versions of documents aligned with their training records, promoting consistency and compliance. 9. Anytime Reference of SOPs in Shopfloor: eDMS enables real-time access to Standard Operating Procedures (SOPs) from the shop floor or any other work area. By accessing the eDMS system through devices such as tablets or mobile devices, employees can instantly refer to relevant SOPs, work instructions, or guidelines while performing

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Remarkable height of digitalization in Pharma Businesses with DMS

Go Paperless with Document Management System Gone are the days when we used to keep all our essential information and crucial data in tones of logbooks. Here comes the new era with new innovative options to get those things done without any hassle, Electronic Document Management Software. When you have a lot of data to input, limiting to manual documentation becomes exhausting, expensive, and time-consuming. Whereas with this digital add-on the entire documentation task in contemporary pharma and life sciences industries are being managed easily with organized creations of automated documents. Helping several businesses to organize their paper works digitally, with EDMS companies are now transforming themselves from paper-based to completely paperless, which is more resolved and easier to access. Coming up with a lot of helpful features, EDMS is the one that all businesses need to incorporate in their whole-sole documentation category inviting further business growth. Successful business accomplishment with eDMS With FDA’s 21 CFR part 11 regulation, it has been clarified that all the electronic records including signature and other documents will be treated as the final ones replacing the paper-based records. This has ultimately given us a sign that contemporary life sciences, pharma and biotechnology industries should take a step ahead accepting this effective-cum-painless digital trend. With Electronic Document Management, automatic feeding of data to tracking it down with needed information and further documentation has really become an uncomplicated process. Let’s celebrate this user-friendly innovation with certain benefits it has given to pharma businesses battling with some crucial challenges. Starting from document creation, review, approval, edit, rework, everything used to be handled with manual interferences, whereas eDMS has brought all these tasks into a proper streamline where every stage is managed automatically with no or rare human intervention. When this manual documentation takes a lot of quality time as an investment, the whole streamline breaks if one employee is not staying updated with the whole process. Hence, it is altogether a break of workflow as well as time-intensive work. On the other hand, eDMS will maintain the entire workflow consuming minimal time, and the rest quality time can be used in other areas of growth. In a pharma business or life sciences company, there occurs frequent changes in the regulatory and certain compliances. Keeping a tab on all those recent updates becomes a tough job with manual documentation. Whereas, with eDMS you stay updated about all those changes and have a keen observation of the whole track activities. Ever thought where to keep those shedloads of documents? What will you do when you have an urgent meeting to look after and the file you are searching for is missing? And here comes another advantage of EDMS Software. Manage a common hub for all your important data collectively under one cloud and access easily whenever required. Manual feeding means a huge chance of missing some important data or incorrect data input or mismatch of data inserted. We certainly cannot avoid these terrific situations in manual management, but these can be resolved with automatic eDMS, where you get instant reminders, notifications, or escalation pop ups immediately the software finds any error in data or needs revision of data. Documentation is not only restricted to maintaining the paperwork’s, but along with the data it is also required to keep an eye on parallel departments like production, operation, quality assistance, etc. This can be done smoothly with the help of Document Management Software whereas it’s a tougher manual task. In an organization where a lot of employees do work, keeping their data is really hard work and sometimes we miss data which could create trouble afterwards. Well, with DMS each detail of all the employees is being secured under the shed of a specific cloud and it is easily accessible through secured and personalized credentials. When we keep or preserve data using DMS instead of manual documentations there is no chance that a natural calamity or fire attack in the storage area will destroy the data. This is high time when every business is transforming themselves from human-operated to automated, Document Management System of AmpleLogic is encouraging budding as well as established pharma and life sciences companies to enlarge their scope of digitalization with a smart modern touch. Its motto is to channelize end-to-end digitalization in several pharma industries with the impact of trending Pharma 4.0 and full-fledged automation.  Schedule a call with the AmpleLogic team to enroll for a free demonstration of Electronic Document Management System Software. 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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Streamlining Pharmaceutical Manufacturing with DMS Software

Maintaining strict quality standards, efficient processes, and compliance with regulatory requirements is paramount in the highly regulated and complex pharmaceutical industry. Document control plays a pivotal role in ensuring that manufacturing processes are well-documented, consistent, and adhere to regulations such as Good Manufacturing Practices (GMP) and the Food and Drug Administration (FDA) guidelines. To achieve these goals, pharmaceutical companies increasingly use document control software solutions. Document Control Challenges in Pharma Manufacturing Pharmaceutical manufacturing involves a multitude of processes, from research and development to production, testing, and distribution. With numerous stages and departments involved, managing documents manually can become overwhelming and error-prone. Some of the challenges faced include: Version Control: In a dynamic manufacturing environment, documents such as Standard Operating Procedures (SOPs), batch records, and work instructions are frequently updated. Keeping track of the latest version and ensuring all relevant stakeholders can access it can be challenging. Compliance and Audits: Regulatory bodies demand pharmaceutical companies to maintain accurate and up-to-date documentation to ensure product quality and patient safety. Preparing for audits and inspections can be time-consuming and stressful without proper document management. Collaboration: Collaboration among various departments and teams is essential in the pharmaceutical industry. Ensuring that the right people can access the right documents while maintaining control over editing and changes. Traceability: Tracking changes made to documents is vital for accountability and meeting regulatory requirements. Manually tracking modifications can lead to errors and inefficiencies. Security: Protecting sensitive information and maintaining data integrity are paramount. Unauthorized access to critical documents can have serious consequences. Benefits of Document Control Software: Document control software designed for pharmaceutical manufacturing addresses these challenges and offers numerous advantages: Version Control: Automated document control software ensures that only the latest version of a document is accessible. It eliminates confusion caused by outdated documents and prevents the use of incorrect procedures. Centralized Repository: All documents are stored in a centralized digital repository, accessible to authorized personnel from different locations. This streamlines information sharing and collaboration. Workflow Automation: Document control software can automate approval workflows, ensuring that relevant stakeholders review and approve changes before implementation. Audit Trail: An electronic audit trail captures all changes made to documents, including who made the change and when. This feature simplifies audits and ensures accountability. Access Control: Role-based access control ensures only authorized personnel can access, view, edit, or approve documents. As a result, it enhances security and prevents unauthorized modifications. Search and Retrieval: Advanced search capabilities allow users to quickly locate specific documents, reducing time spent searching through physical files or shared drives. Electronic Signatures: Digital signatures provide a secure way to approve documents, and regulatory agencies legally recognize them. Integration: Many document control solutions can integrate with other quality management systems and tools, creating a seamless ecosystem for managing processes and documentation. Choosing the Right Document Management Software: When selecting document control software for pharmaceutical manufacturing, consider factors such as: Regulatory Compliance: Ensure that the software meets industry-specific regulations and guidelines. Customizability: The software should adapt to your company’s unique processes and workflows. User-Friendly Interface: The software should be intuitive and easy for all users to navigate. Scalability: Choose a solution that can grow with your company’s needs and evolving regulatory requirements. Security: Robust security features, encryption, and user access controls are essential. Support and Training: Look for a provider that offers adequate support and training to ensure successful implementation. Conclusion In conclusion, document control software plays a vital role in streamlining pharmaceutical manufacturing processes, ensuring compliance, and maintaining product quality. By adopting the right software solution, pharmaceutical companies can improve efficiency, reduce errors, and enhance collaboration while meeting the industry’s stringent requirements. 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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Achieving data integrity is made easy with eDMS in the pharmaceutical industry

Data integrity reaffirms the pharmaceutical industry’s commitment to manufacturing safe, effective drugs that satisfy quality standards. Simultaneously, data integrity is a vital tool for regulatory authorities to employ in protecting public health. Recent FDA Form-483 observations and warning letters reveal that data integrity is the major issue the pharmaceutical industry is currently dealing with. Failure to comply with data integrity requirements may result in many un-validated results, which may cause post-marketing issues and frequent product recalls. Therefore a comprehensive approach is necessary to address the underlying causes of data integrity problems, which lead to poor quality culture, organizational or individual behavior, leadership, processes, or technology. Therefore, appropriate software is vital for enforcing practices necessary for compliance and easing the burden for both parties. This software’s functionality supports audit trail maintenance and review and streamlines systems to enhance productivity. Industry trends shaping audit demands In recent years, the focus on data integrity has intensified, followed by warning letters, notices of concern and statements of non-compliance. Authorities seek to reduce incidents of poor data integrity by promoting transparency and revamping regulatory guidelines related to pharmaceutical manufacturing. Electronic data systems have overtaken paper as part of the shift towards greater transparency, making data increasingly searchable, accurate, and difficult to forge. The enforcement of ever-evolving audit trail regulations is driven by one underlying factor, which is the demand for high-quality products. To this end, the US Food and Drug Administration (FDA) is considering novel strategies for incentivizing mature quality management systems. Moreover, FDA has suggested introducing a rating system for pharmaceutical companies. Here, they can reveal a rating indicative of their commitment to establishing quality management systems that help anticipate problems before they arise. As a result, this move would provide companies with robust quality management maturity and competitive advantage, potentially allowing them to grow their market share. Data integrity is essential for reshaping the pharmaceutical industry and triggering significant innovation to ensure the information’s reliability and trustworthiness. In the future, the significance of implementing measures and practices that frame the integrity of the collected data through the whole life cycle of a product will increase. Now, companies that have started implementing the DI practices and a DI program will likely gain considerable advantages over their competitors. Certainly, here are some points highlighting how achieving data integrity is facilitated by using an electronic Document Management System (eDMS) in the pharmaceutical industry: Centralized Storage: eDMS provides a centralized repository for all documents and data, ensuring easy access, retrieval, and management of critical information. Version Control: The system records document versions, revisions, and updates, minimizing the risk of using outdated or incorrect information. Audit Trail: eDMS creates an electronic audit trail that captures user actions, edits, and document history, offering transparency and accountability. Role-based Access: Access controls and permissions are enforced, limiting document access to authorized personnel enhancing security and confidentiality. Electronic Signatures: Digital signatures add an extra layer of authenticity to documents, making them legally binding and tamper-proof. Workflow Automation: Automated approval workflows streamline document review and approval processes, reducing human errors and accelerating document lifecycle. Data Integrity Checks: eDMS can include built-in data integrity checks to ensure accurate data entry and prevent inconsistencies. Validation and Compliance: eDMS platforms can be validated to comply with industry regulations like 21 CFR Part 11, EU Annex 11, and GxP guidelines. Reduced Paper Usage: By transitioning from paper-based to electronic processes, errors due to manual data entry are minimized. Real-time Collaboration: Teams can collaborate on documents simultaneously, promoting real-time feedback and updates while maintaining data integrity. Search and Retrieval: Advanced search capabilities in eDMS enable quick retrieval of documents, reducing time spent on data searches. Backup and Disaster Recovery: eDMS systems often include data backup and recovery mechanisms, safeguarding documents against loss or corruption. Regular Audits: The system supports regular audits and inspections, ensuring data integrity and regulatory standards compliance. Data Validation: eDMS can include validation checks to ensure data accuracy, completeness, and adherence to predefined formats. Training Records: eDMS can manage training records, ensuring that personnel accessing documents are adequately trained and qualified. Consistency Across Sites: Multisite organizations benefit from standardized processes and data integrity practices across various locations. Compliance and workflows are made easy with Amplelogic’s Document Management System (DMS) The pharmaceutical industry is under immense pressure to show greater transparency and data integrity to provide a reliable supply of high-quality pharmaceutical products. Accurate and evolving audit trail regulations reflect the necessity to safeguard public health and represent a primary challenge for manufacturers. To remain compliant, manufacturers demand software systems qualified to handle all datasets without compromising productivity. Therefore, implementing an Amplelogic DMS helps you to achieve compliance, simplify audit trail reviews and enhance workflows. Here are a few features of Amplelogic’s DMS to simplify compliance and audit trail reviews: A user can develop templates for any document kinds, and the workflow can be set according to the SOP. It keeps track of the most recent version of every document created and makes it easy to access that version. Integrates with other systems, such as Quality Management Systems (QMS), Learning Management Systems (LMS), and so on, to simplify document preparation and handling. The dashboard displays all the pending tasks of the end user. An archiving mechanism helps the data to be archived at a predetermined time frequency based on the company’s SOP. To learn more about our software, click on this link to explore. 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cloud software devlopment
DMS

Document Management Systems is a boon to the Topical Pharmaceutical Sectors

Incorporating new-age technology in Lifesciences: With digitalization in impact there has been a lot of astounding changes in every industrial sector including pharma and life sciences companies. When practically we have uncovered countless benefits of this new age inculcation in the global market, we also cannot walk away from the fact that digitalization has also disrupted industries on various other levels. With this we conclude that every innovation comes with certain pros and cons! But humans have always found out ways to deal with the harsh part of any innovation and so they have dealt with this too. Keeping customer satisfaction and business extension at the forefront, contemporary pharma industries have started adopting digitalization trends in their manufacturing as well as operation and document management system is one among many. With this, automatic integration of all the document-related activities of a pharma sector has been way easier & simpler. Transforming paper-based activities to automatic paper-less ones smoothly with less cost consumption is the whole-sole intention behind this digital trend in pharma companies. DMS: Get it transformed from Manual to Automatic Pharmaceutical industries go through a huge number of paper activities every day and to manage them there is a high requirement of resources. But, with manual interferences there is a quite good chance of information mismatch, incorrect feeding, untimely delivery, etc. Whereas with DMS or Document Management Systems, all these activities can be handled easily without any manual activities. Whatever is the phase of the entire pharmacy function, on every stage there is a big need of maintaining all the informative documents safely, so that they can be accessed whenever required without any hassle. In a way, DMS has contributed a lot to the content management activities encompassing all the electronic data like emails, batch records, quality control records, crucial regulatory details, etc. Instead of creating a pile of informative files manually one after another, through the Electronic Document Tracking System one can easily find all the important data stored in one place accessible from anywhere. Besides, FDA’s 21CFR Part 11 compliance says that it has been mandatory for all the organizations to replace their paper-based documents and signatures with electronic records and e-signatures. Aiming to better the document maintenance of the pharma companies, AmpleLogic is also encouraging life sciences industries to introduce eDMS into their business activities and attain a tag of paperless company. Using Document Management Systems, a lot of things can be handled efficiently in a specified manner and many challenges faced by Lifesciences industries can be tackled easily. Sort of difficulties industries face these days with manual activities in pharma industries are: Excessive Time Consumption: because of paper-based activities, one channel stays dependent on the other every phase, which consumes a lot time. besides, it hampers streamline planned for project. with document manager, this whole manual set-up can be processed smoothly and automatically without any hassle. Probability of Errors: When the whole documentation is managed manually, there is a huge probability of misplacement of documents. With this, it becomes difficult to get the accurate document or data whenever required. Poor Tracking Activities: It becomes difficult to keep a tab on the tracking activities of various regulations being updated in several pharmaceutical industries. Lagging on training the resources: With DMS software, it becomes easy to integrate learning management systems (LMS) with the documents, automatically. When these things are done manually, then it lacks integration and resources are not being intimated about the trainings to be taken as per their domain and skills. Last-minute rush: With many things altogether, it is tough to memorize a few revisions work, which can be done easily using eDMS. It will intimate users with automatic notifications, reminders, escalations, etc. without any miss, so that things can be done before the deadline. Inefficient collaboration: In manual document management it becomes tough to collaborate various departments like operation, production,quality assurance, engineering, etc. in a perfect streamline, which can be accomplished using DMS. Unsecured data storage: Keeping a stack of paper-based documents in a physical storage could be dangerous when they face unprecedented accidents like fire or anything. Why not use a secured cloud for orderly document control? When there has been an inevitable need to consolidate digitalization to the contemporary life sciences industries, then we must consider the Document Management Systems as the very first trend to bring in. Understanding the benefits of eDMS, AmpleLogic is assisting various pharmaceutical companies around the globe to add this seamless and cost-effective integration to their business. We would like to resolve all your queries on DMS, reach us for a quick demonstration. 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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