What do you think high-performing pharmaceutical companies might be doing to perform better? You will observe that they are quick to identify and resolve issues. Also, they use relevant tools and innovations for process efficiency and to maintain a culture of quality.
At No deviation, we have partnered with Kneat, Mirrhia, Klaxoon and PlantQuest to help us focus on high-quality patient-centric solutions. Here are some solutions offered by them that could help your pharmaceutical company perform better in your day-to-day operations.
Paperless validation software with Kneat
This has distinctly revolutionized the traditional validation practices in pharmaceutical, life sciences, medical devices and other GMP-compliant industries. The time, effort and cost incurred in creating, maintaining and storing enormous quantities of paper documents that are required for everyday operations are great. In fact, paper-based validation documents absorb resources in activities that neither provide value nor are technical in nature. Inefficiency is another factor to consider.
Paperless validation software offers a cost-effective validation solution to pharma companies through fully digitising and managing the validation life-cycle. Such a system will achieve:
– Increased productivity
– Quality assurance
– Reduced time-to-market, change-over and cycle-times
– Consistency and compliance
– Data integration
– Integrated validation and change management process
– Real-time equipment release
– In-depth, instant visibility
Our partner, Kneat Solutions offers a rich paperless validation platform, KneatGx™, purpose-built for the life sciences industry, which makes validation easier, faster and smarter. This standalone SaaS enterprise solution digitizes the entire validation life-cycle, enabling validation teams to author, review, approve, test-execute, manage exceptions and post-approve any business process in a 21 CFR Part 11 compliant web-based software that’s securely accessible anywhere with an internet connection.
You can contact us at kneat@nodeviation to learn more about our paperless validation services in collaboration with Kneat Solutions.
Environmental monitoring system (EMS) with Mirrhia
In the pharmaceutical industry, cGMP manufacturing requires a validated monitoring system that follows GAMP specifications. An EMS monitors the critical environmental parameters within a facility and collects and records this data to verify compliance. Environmental parameters deemed GMP-critical include temperature, humidity, particle count, and pressure. If properly designed, an EMS will also record the data from support equipment such as freezers, fridges, incubators etc. All these elements are GMP-critical for product release, with set parameters for the environment and equipment that are within determined alarm set-points, spanning production through to shipping. This is also applicable to transportation wherein the product requires a particular environment to remain stable.
Mirrhia is one such global GMP monitoring platform. It is centrally validated, configurable, scalable and can control all critical parameters. It offers various features on a single platform, including alarm management, intelligent monitoring, microbiology traceability, calibration management and more.
Learn more about the No deviation and Mirrhia partnership or get in touch with our team for more information about the EMS.
Project management with Klaxoon
Project management in a pharmaceutical company is challenging. This is because there are numerous facets to be considered, such as timeline and budget planning and management, scope management, project planning, execution and monitoring, regulatory and compliance management, risk management, team management, environment safety and stakeholder management. Moreover, these facets are interdependent, greatly increasing the complexity of project management, and causing delays in the project timeline should there be any deviation from plans.
Pharma companies need to be highly efficient in all aspects of business, and cross-functional team communication and collaboration are vital in minimising the risks in projects. The right project management tool can go a long way in enabling processes to move according to plan. Such tools enable companies to harness the power of their teams through specifically designed solutions that increase the efficiency of meetings and make work practices more collaborative. Through an array of functionalities and scalable interfaces, these tools aid in:
– Increasing engagement
– Improving information dissemination and retention
– Facilitating better, faster decisions
– Enabling quick access to documents
– Increasing visibility
– Simplifying workload
– Etc.
Klaxoon, a global expert in cloud-based teamwork solutions offers a sophisticated SaaS platform of tools, which improves efficiency and engagement in team meetings and more. It can be used at the office or remotely.
You can get in touch with our team for more information about Klaxoon.
Tracking critical equipment with PlantQuest
A pharma manufacturing unit has a very large number of assets, and the location of fixed and portable assets may sometimes become an issue in areas of safety, maintenance, and operational tasks. The use of current resources including complex layout drawings and P&IDs are time-consuming and not very safe or efficient. In fact, searching for fixed equipment could even be the source of project delays.
PlantQuest, a software company headquartered in Waterford, Ireland, saw the opportunity to provide a Google Maps experience, only, in this instance, inside the work environment. The company provides a mobile and desktop solution to workers that enables them to locate assets or groups of assets within an industrial unit. The algorithm-based navigation system is signal-free, not requiring GPS, Bluetooth, WIFI or 4G, which means there is no need for the installation and maintenance of expensive telecom infrastructure.
There are other advantages to using such location and navigation solutions, including:
– The reduced time to complete critical tasks
– Increased efficiency
– Increased productivity
– Reduced risk, and thereby, increased safety
– Enhanced emergency response
– Effortless asset management
PlantQuest can be used during all phases of a project.
As evident, certain well-chosen tools go a long way in helping pharmaceutical processes to become quicker and more efficient. New solutions are constantly evolving and presenting themselves. It should be noted that while it’s always good to remain open to cutting-edge technologies, it’s important to fit the tools to your requirements, rather than chase the latest trend.
You can contact us at admin@nodeviation.com to learn more about No deviation’s partnership with PlantQuest in providing location and navigation solutions for the pharmaceutical industry.
At No deviation, we partner with you to help you with executing your CQV process, troubleshooting or your CAPA, or implementing new digital solutions. Our team will come with an open mind and follow the simple steps that are Understand, Observe, Define, and Implement.
Reach out to us for a full risk-based paperless validation with integrated commissioning and test plan or to bring efficiency to your existing paper-based IQ, OQ execution. You can also visit our website for more information on our services.
Pierre is a Chemical Engineer and the CEO of No deviation. He likes to develop a team vision for quality accountability and innovation. He is hugely optimistic and sees the opportunity in every task he undertakes.
