Rescop

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  • 0 ECA -Academy Computer Validation Seminar

    • by Maurice Kerens
    • 03-08-2020
    3.00 of 1 votes

        We are proud to announce that we will be a part of ECA – Academy conference on 27 & 28 - 30 October 2020 as a speaker.   Highlights Regulatory Update Leveraging Suppliers - Managing Quality - Leveraging Test Activities - Supplier Assessment Good Validation Practices Scalability of Validation Advanced Risk Management IT Governance Data Integrity Change Control Management Upcoming Challenges in IT Learning by doing: up to 10 Workshops Interactive sessions   For more information check the ECA Website : https://www.gmp-compliance.org/training/gmp-course-conference/computer-validation-leveraging-suppliers      

  • 0 Data Integrity - Online training

    • by Rescop
    • 18-06-2020
    5.00 of 1 votes

    Rescop Turnkey Projects & Advisory - Data_Integrity   Rescop has a standard data integrity toolbox available, developed based on 21CFRPart11, Eudralex Annex 11, the GAMP Guide and Rescop’s experiences in practice. Possibility of deployment of onsite project team that has experience with data integrity projects and FDA / EU inspections is key for knowledge sharing and teamwork!   Our Rescop Academy Services provides free Online training for Data Integrity: Will be present by Richard Mulders and Rafal Buczek - 25 June 2020 / 4-5 PM For Registration : https://rescop.com/webinars.php    

  • 0 VALIDATION USING AGILE

    • by Rescop
    • 08-06-2020
    5.00 of 1 votes

        Although Agile and Validation feel like a contradiction, Agile development can help you to efficiently validate your systems. Just imagine that during development/implementation of a system the components which are already completed can be used but are also validated for their intended usage.     Rescop Academy can help you with the method and tools to make this imagination become reality; instead of validating your system during the full development and implementation, Rescop Academy’s Agile Validation method will help you to validate parts of a system in an early stage.     Rescop provides Agile Validation using training on various levels: Foundation and Practitioner. Both training levels combine the theory from the Agile (SCRUM) / SAFe, ISPE GAMP® 5 Guide: Compliant GxP Computerized Systems and the AAMI TIR45 guidelines with exercises to simulate the practical implementation.   Validation using Agile Foundation The Foundation level training is suitable for people who need to be aware of what Agile and Scrum is and how it can be used in a regulatory environment. The training includes practical examples on how to do it.   During this training you will learn: • How the benefits of Agile development methods can be leveraged within the strict world of compliance        (validation)• How to implement Agile development methods in practice• Differences between small and large projects / programs when using Agile development methods• Focus on product / system quality instead of on validation documentation to validate• How to apply Rescop Academy’s Agile Validation method to help you to validate parts of the system in an early stage   You can get a small impression of the training.  Register free for our next coming Agile validation webinar.  Free registration      

  • 0 White Paper - Rescop Quality Management Suite (RC-QMS) - Security and GDPR

    • by Jan Bloo
    • 26-05-2020
    0.00 of 0 votes

    Rescop Quality Management Suite (RC-QMS) - Security and GDPR PUBLIC and the revision date 13-MAY-2020 •    Rescop meets the most extensive compliance standards.•    Rescop utilizes Microsoft's Azure secure cloud services.•    Rescop's platform and infrastructure are monitored continuously. •    Rescop complies with GDPR as a data processor in the provision of Rescop’s services to its customers. An Industry StandardRescop is the digital paperless pioneer in a GxP Compliance world. Founded in 2005, Rescop Quality Management Suite (RC-QMS) is used by companies worldwide, spanning all industries, platforms and sizes.Hosting and Infrastructure Rescop RC-QMS Software-as-a-Service (SaaS) solution is available for private clouds utilizing top-tier secure cloud services provided by Microsoft Azure.Microsoft AzureIn a world where data breaches are daily occurrences and regulatory requirements for protecting data are increasing, it's essential for organizations to choose a cloud service provider that makes every effort to protect customer data. Microsoft is committed to the highest levels of trust, transparency, standards conformance, and regulatory compliance. Our broad suite of cloud products and services are all built from the ground up to address the most rigorous security and privacy demands of our customers.To help organizations comply with national, regional, and industry-specific requirements governing the collection and use of individuals’ data, Microsoft provides the most comprehensive set of compliance offerings (including certifications and attestations) of any cloud service provider.For more information:  https://www.microsoft.com/en-us/trustcenter/complianceCompliance Rescop is ISO 27001:2013 certified for Information Security and ISO 9001:2015 certified for Quality Management.Penetration Tests and Monitoring Rescop’s front and back-end applications, as well as its IT infrastructure undergo frequently pen-tests. This is done in addition to Microsoft’s own independent tests, periodic internal tests, and 27/4 monitoring of security-related events.  Certifications and Accreditations ISO 27001 Information Security Certification Rescop received the International Organization for Standardization Certification for Information Security (ISO 27001:2013). The audit evaluated Rescop's Information Security Management System from product, infrastructure and organizational aspects, and verified that Rescop has the necessary information security controls in place to ensure the confidentiality, integrity and availability of valuable data and information assets.Rescop's alignment (as verified by an independent third-party audit agency) with this internationally recognized code of practice demonstrates Rescop's commitment to the privacy and protection of customers' content. By following the standards of ISO/IEC 27001, Rescop demonstrates that its policies and procedures are robust and in line with its high codes of practice, namely:•    Rescop customers know where their data is stored.•    Customer data won’t be used for marketing or advertising without explicit consent.•    Rescop customers know what’s happening with their Privacy data.•    Rescop will comply only with legally binding requests for disclosure of customer data.ISO 27032 Guidelines for CybersecurityRescop is ISO/IEC 27032 complying to guidelines for Cybersecurity. ISO/IEC 27032:2012 provides guidance for improving the state of Cybersecurity, drawing out the unique aspects of that activity and its dependencies on information security, network security, internet security, and critical information infrastructure protection (CIIP) domains. By complying, Rescop facilitates a secure and reliable collaboration that protects the privacy of our customers and helps to prepare, detect, monitor, and respond to cybersecurity incidents.GxP ComplianceGxP is a general abbreviation for "good practice" guidelines and regulations. Technology systems that support GxP processes such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP) require validation and qualification of adherence to GxP requirements. Solutions are considered qualified when they can demonstrate the ability to fulfill GxP requirements. RC-QMS GxP ComplianceOur fully web based solution, which runs on the common browsers and is cross-platform compatible to allow for use on any device type, including pc’s, laptops, tablets and smartphones. Our solution will help you to establish and maintain a GxP-compliant and reliable IT infrastructure and application landscape for continuous business operations. The RC-QMS suite is developed according GxP regulations and fully tested before delivering to customers in a pre-validated way.Rescop Quality Management Suite (RC-QMS) forms a comprehensive solution for quality and compliance management within regulated industries. It contains products for all key quality management processes, and these products have been designed in such a way that they integrate seamlessly with each other, to enable an efficient and fully paperless quality management system.RC-QMS is a full solution for ensuring permanent inspection readiness in an efficient way. Moreover, RC-QMS enables paperless validation and compliance. Cloud GxP ComplianceOrganizations building GxP solutions on Microsoft Azure can take advantage of the cloud’s efficiencies while at the same time helping protect patient safety, product quality, and data integrity. Customers also benefit from Microsoft Azure’s multiple layers of security and governance technologies, operational practices, and compliance policies to enforce data privacy and integrity at very specific levels.The Microsoft Azure GxP qualification guidelines give customers the tools they need to build on Microsoft Azure’s security foundation by providing:•    The shared responsibilities between Microsoft and Rescop for meeting GxP requirements•    Documentation of the extensive controls implemented as part of Microsoft Azure’s internal development of security and quality practices•    Visibility into crucial areas of internal Microsoft Azure quality management, IT infrastructure qualification, and software development practices•    Descriptions of GxP-relevant tools and features within Microsoft AzureWe are partnering with Microsoft Azure to make cloud-based systems a safer, more efficient model for driving innovation and maintaining regulatory compliance.For more information: https://aka.ms/gxpcompliancePrivacy – General Data Protection Regulation (GDPR) Rescop complies with GDPR as a data processor in the provision of Rescop’s services to its customers. In addition, we are devoted to helping our customers with their GDPR compliance processes by providing robust privacy and security protections built into our services and contracts.By default, Rescop does not collect personally identifiable information (PII) other than IP addresses in logs for security purposes, end-users’ approximate geolocation (country and city in which they are located) and masked IP addresses for the ongoing operation of the Rescop systems. Moreover, Rescop collects and transfers environment properties such as browser and OS, page URL, and title. Operations and Access Control  Security Measures •    All the client files in RC-QMS are encrypted in rest state.•    All RC-QMS files are encrypted in transit state.•    The database of RC-QMS is encrypted.•    The RC-QMS security log is recording personal data: User (Last, First Name), Username, External IP Address.•    All RC-QMS servers are under change control.•    All RC-QMS servers are under access control.•    Backups are taking and stored encrypted by Microsoft Azure and ATERA.  Monitoring & Auditing Intrusion Prevention and Detection Rescop has an extensive Security Information and Event Management system (SIEM), that collects security audit trail logs across infrastructure components in industry standard formats (CEF and Syslog) using an Intrusion Detection System and for analysis and control.Rescop’s SIEM alerts are based on comprehensive pre-defined scenarios, including identification of suspicious signs such as failed login attempts, logins from unknown and off-premise IP addresses or logins during off-hours.SIEM alerts are monitored 24/7 by Rescop. The SIEM prioritizes all alerts, notifies in real time, and escalates them according to severity. Access Control User Management and Permissions Rescop’s platform has an integrated, comprehensive role-based user management and enforcement system.Assigning roles to users requires authorization from the relevant parties in Rescop, and application permissions are granularly controlled per action and screen.  Rescop’s internal corporate access control is centrally and manually managed based on strict need-to know and least-privileged principles on all levels: Application (strong authentication), Network (segmentation, firewall), Platform (access to servers), and procedural (who’s granted to review/approve code, manage changes, etc.).All internal duties within Rescop are segregated. Access verifications are done by internal audits and period reviews, including but not limited to firewall rules, user accounts permissions etc.Overall Conclusion Rescop as the developer of RC-QMS, backed with an uncompromising commitment to GxP, security and privacy, is trusted by companies worldwide. Rescop makes sure to comply with corporate, governmental and (inter)national regulations, maintaining and abiding by the strictest requirements, regulations and security measures at all levels – from its staff, through infrastructure and down to the finest details of its products and procedures.Rescop has received the most demanding international certifications ISO 27001 and ISO 9001, and offers its customers the ability to enforce corporate governance internally, while providing an overarching security umbrella – hosting Rescop’s environments with Microsoft Azure Cloud Services, actively monitoring customer security 24/7, and performing frequently  pen-tests on Rescop’s platforms.Maurice KerensManaging Director Software Development and ImplementationJan BlooCorporate Director Quality Assurance

  • 0 RC-QMS RC-SLM - NEW LABEL FEATURE!!

    • by Maurice Kerens
    • 26-05-2020
    0.00 of 0 votes

    RC-QMS RC-SLM - NEW LABEL FEATURE!! Our new "Labels" feature allows printing labels for systems using RC-SLM suite. Labelling helps identify and track down: Calibration schedules Maintenance information Much more System-related information The feature allows you to have multiple labels at the same, customize to your needs. Labels are generated automatically using the System data available in RC-SLM, so there is no risk of making a mistake when preparing the labels manually. Your system has a lot of configuration items? No, problem. It is possible to generate labels for all of them with one click! Using our labels saves your time and limits manual mistakes.   For more information, contact us or request a free demo : DEMO REQUEST

  • 0 The future of Computerized System Validation (CSV)

    • by Adriaan Wanner
    • 26-05-2020
    5.00 of 1 votes

      According to the FDA a lot of pharmaceutical companies are struggling how to embrace the new ways of working and how adapt and implement new (digital) technologies. They have questions like: Should we transition to Agile way of working; Should we use tooling for our validation documentation; Should we automate our testing. Based on my experience companies are still focusing too much on meeting regulatory requirements via heavy loaded documentation packages. Not adopting best quality practices like the new technologies and ways of working has the potential to increase risk to patients. With the current focus we focus too much on having it documented (Good Documentation Practices) and not having a safe product for our customers. The compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing, product development (both medicines and automated systems) and validation practices. The FDA has acknowledged this struggle a few years ago and is currently focusing on Computerized System Assurance instead of Computerized System Validation. A draft version of this guideline will be available in September 2020. With this blog I will start to give our vision on how to implement this CSA approach in the daily CSV practices. Our vision is in line with the new thoughts from the FDA and the proposed guideline. The Rescop vision on the CSA approach will be detailed out in the following blogs which I will write in the coming months: Paradigm shift (less documentation more testing); Risk based testing; New testing techniques and how to capture evidence; Using tools; Vendor assessment. Please contact us for more information via a.wanner@rescop.com    

  • 0 Cloud Computing in a GxP Environment - 26-28 February 2020 | Berlin, Germany

    • by Maurice Kerens
    • 26-05-2020
    0.00 of 0 votes

    We are proud to announce that we will be a part of ECA – Academy conference on 26-28 February 2020 as a speaker. Our Chief Technology Officer, Maurice Kerens with over 30 years experiences in areas of business information management, Enterprise Architecture, supply chain management and IT compliancy will represent us on behalf of Rescop at this GMP Certification Programme.     Highlights   Compliance requirements for Cloud Computing Inspectors‘ / regulators‘ expectations and findings during inspections Types of cloud computing Use of Cloud Computing in a GxP environment Outsourcing and Cloud Computing – what is important for contracts Data Integrity and Cloud Computing IT security and data protection requirements Validation of a Cloud Process Cloud Computing from the suppliers point of view Technology behind Cloud Services Moving to the Cloud     For more information visit : https://www.gmp-compliance.org/

  • 0 The smart pharma (4.0) factory

    • by David van Minde
    • 26-05-2020
    0.00 of 0 votes

    Pharma 4.0, also called the smart factory is a framework for adapting digital strategies to the unique contexts of pharmaceutical manufacturing. This means more connectivity, productivity, simplified compliance and collecting digital production information to respond to problems as they emerge.Digitization, an important component of Pharma 4.0, will connect everything, creating new levels of transparency and speed for a digitalized manufacturing process. This will enable faster process for decision-making and provide in-line and in-time control over business, operations, and quality.Rescop has the unique combination of Compliance software, Consulting services and Training services for GxP Compliance to adapt digital strategies to the unique contexts of pharmaceutical manufacturing.Are you curious how Rescop can support you to implement the Pharma 4.0 smart factory framework?Please contact us for more information via info@rescop.com or sales@rescop.com.

  • 0 AgileOne Platinum Supplier 2019 Awards!!

    • by Rescop
    • 26-05-2020
    0.00 of 0 votes

      We are proud to announce that we received the Platinum Supplier 2019 Award from our partner AgileOne in London! A big thanks to all of our consultants in the field and business support members that continue to deliver high level services to our clients.  

  • 0 The Benefits of Paperless Validation

    • by Bjorn Aalbers
    • 26-05-2020
    0.00 of 0 votes

      Validation is defined by the Food and Drug Administration (FDA) as “Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes”. Traditionally, companies capture the documented evidence on paper, typically using in-house formatted MS Word or MS Excel templates to create the content, and then printing and signing the document to establish a formal version. However, current IT applications and database technologies provide tools required to enable paperless validation. This whitepaper summarizes the benefits of using a software solution for validation within FDA/GxP regulated industries. Standard benefits of introducing an IT Solution When introducing a software solution for validation, the following “standard” benefits which are inherent to IT solutions, are immediately realized, such as: Standardization; paperless validation requires defined validation processes and activities, which will be enforced by the software solution. This will avoid reinventing the wheel and ensure optimization and efficiency gains. Access anytime, anywhere; the use of a software solution will allow global access, through various kinds of devices. This facilitates teamwork and ensures progress of activities, thereby reducing the cycle time for validation. Elimination of paper; paper as a medium requires continuous activities by personnel related to printing, distribution and storage, and these activities can be eliminated by using a software solution. This will lead to efficiency gains and cost reduction, not to mention the positive environmental impact. Control; paperless validation enables visibility of validation activities and provides management with the required tools to control and improve processes. This leads to efficiency gains and cycle time reduction. Traditional benefits of document and workflow management systems Software solutions for validation need document and workflow management functionality as a basis. Besides the standard benefits noted above, this functionality brings the following standard benefits related to electronic document and workflow management: Quicker review and approval processes; automated routing of documents for review and approval, including electronic signatures, will speed up the document workflow by eliminating traditional manual activities related to distribution and signing of paper document versions. This reduces the cost and cycle time of validation. No loss of documents; the risk of losing a paper version during document routing or storage is eliminated when using a software solution. This facilitates compliance and will reduce the time required to search for paper documents, which in turn reduces the cost and cycle time for validation. No paper archive needed; the introduction of a centrally and online accessible software solution will eliminate the need for a traditional physical archive for storage of validation documentation. Although a software solution requires an investment for IT infrastructure to ensure continuous availability and storage of electronic documentation, the reduction of costs related to traditional archive facilities and continuous manual labor related to archive management will lead to an overall cost reduction. Quicker searching and retrieval of documents; searching for paper documents requires a structured and continuously maintained indexing system, which requires a significant amount of manual labor in the case of larger organizations. A software solution for validation will facilitate instant retrieval of documentation based on any query. This reduces the cost and cycle time of validation activities and will ensure that documents are readily retrievable during an audit, as required by FDA/GxP regulations. Benefits specific to validation Besides the standard benefits related to paperless validation and document and workflow management, there are a number of interesting benefits specifically related to using a software solution for validation as follows: Enforcing the order and traceability of both documents as well as content; as depicted in the traditional V-model, validation activities and documents require a specific order and relationship, which can be established and controlled when using a software solution. Furthermore, a software solution makes the validation process and activities transparent, and eliminates the need to manually create and maintain a traceability matrix. By establishing the links between both documents as well as requirements, test cases and results, items can be tracked and subsequent actions assigned to individuals. This, in turn, facilitates compliance. Reduce the costs of validation; by eliminating the human activities required for preserving the order and relationship of documents and content. Reuse of content; in a traditional paper based system, validation documents tend to be rewritten ‘from scratch’ each time. Employing a software solution provides the ability to easily re-use previous content i.e. requirements, test cases, etc. which, in turn, greatly reduces the time and effort involved in producing validation documentation. Focus on the actual validation work; by eliminating the manual labor related to workflow and document management, validation personnel can fully focus on the actual job of validation, entailing planning, specification, testing and reporting. This facilitates compliance and reduces the cost and cycle time for validation. Management reporting; one of the major challenges in managing a validation project is accurate reporting on open activities, especially documents in the process of review or approval. Software solutions typically provide a real time view on the progress of activities which enables management to make timely decisions and take appropriate actions in an efficient manner. IT Solutions Although the benefits of paperless validation compared to the traditional way of working may be clear, it can still be a challenge to convince stakeholders of an organization for the need for investing in a paperless validation solution. When evaluating the IT budget and prioritizing solutions, the benefits of IT solutions supporting primary business processes are typically perceived as more tangible compared to a quality management solution like a validation lifecycle management system. However, the aforementioned summary of benefits should provide solid reasons to justify the investment in paperless validation. Rescop provides global consulting services and software solutions for FDA/GxP compliance and has extensive experience in setting up business cases for paperless validation solutions. In addition, Rescop can provide real world examples of cost and cycle time reduction based on implementing and using paperless validation solutions in practice.