Rescop

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  • 13 Rescop free Webinar training

    • by Rescop
    • 26-05-2020
    5.00 of 1 votes

    Rescop free Webinar training   Rescop is offering free online trainings the upcoming months. In the time of COVID19 we find it important to contribute to our industry by sharing knowledge and supporting personal development. The first online training will be on Thursday 16th April 2020 on Life Cycle Process Validation by Jos Nieuweboer, Principal Consultant. Jos will give an introduction on life cycle process validation and share some insight on the latest developments.   Register now and save your place: Free registration.

  • 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 GMP Certification for Medical Cannabis

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

      Are you looking for a GMP certification for growing, extracting and manufacturing cannabis for medical use?   You’ve come to the right place.   Manufacturers of medicines must comply with Good Manufacturing Practice (GMP). GMP requires that medicines:   Are of consistent high quality; Are appropriate for their intended use; Meet all applicable requirements.   For more information contact us!

  • 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.  

  • 0 ISO 27001:2013 Certified

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

      Rescop, a Dutch-based GxP company, providing GxP Consultancy and creator of the RC-QMS Software Suite for small and medium enterprises and large organizations from around the world, has been awarded the International Organization for Standardization certification for Information Security Management (ISO/IEC 27001:2013). The ISO/IEC 27001:2013 Certification is one of the widely accepted and globally recognized security standards that enable organizations to identify, prevent and defend potential security vulnerabilities. Rescop’s compliance with the ISO standard was certified by LRQA (Lloyd’s Register Nederland) Certification – Netherlands, the world’s leading certification body. It demonstrates the company’s strong commitment to the ongoing maintenance and development of its Information Security Management System (ISMS), making information security and data protection an integral part of all its business processes. “The ISO 27001 Certification completes our vision for Rescop as a RC-QMS provider,” said Maurice Kerens, Chief- Technical- Officer (CTO) of the organization. “Rescop’s is and has always been a forward-thinking GxP company. We believe that data security is essential to the stability of companies, providing our new and existing clients with an extra level of safeguard for their information assets.” The ISO/IEC 27001:2013 Certification is a showcase of Rescop’s overall strategy to ensure that its RC-QMS comply with the highest international and regional standards, and that its services are based on globally accepted standards and protocols. The rigorous audit process entailed thorough interviews with various departments such as Development, Implementation, Quality Assurance, Human Resources and Finance, as well as investigation on risk management, physical security, access controls, and security best practices. Rescop’s ISMS successfully met all logical, process, physical and management controls to achieve compliance with the standard. “We are proud to have earned this certification, attesting that our highest level of controls is in place when handling client’s confidential information.”