It is a system that manages and tracks training for personnel working in biotechnology and biologics environments to maintain compliance with GLP, GCP and GMP standards.
In the cutting-edge field of biotechnology, innovation, compliance, and precision are paramount. Our industry-leading ISOtrain LMS is meticulously designed to meet the unique challenges of the biotechnology sector, enabling companies to excel in a rapidly evolving landscape. With robust features and unparalleled functionality, our platform facilitates seamless training and regulatory adherence, empowering biotechnology organizations to push the boundaries of science and discovery.
We provide comprehensive understanding of biotechnology regulations, including GLP, GCP, and other standards, ensuring alignment of training programs with regulatory requirements and offering adaptive learning paths tailored to individual learner needs.
Tailor training programs to address the specific needs of your biotech workforce. With adaptive learning paths, employees can progress at their own pace and focus on areas where they need the most improvement, leading to enhanced skills and performance.
Our system offers real-time monitoring of compliance status and training progress, coupled with automated alerts for expiring certifications and upcoming training deadlines. This proactive approach allows you to manage compliance risks efficiently and address potential issues before they impact operations or regulatory compliance.
Centralize document control and ensure accessibility of critical documents such as SOPs, protocols, and regulatory filings through our seamless DMS integration tool, streamlining processes and enhancing regulatory compliance.
Our platform provides access to a wide range of customizable reports and dashboards, offering insights into training effectiveness, compliance metrics, and performance trends. Leveraging data-driven insights, you can optimize training programs, identify areas for improvement, and demonstrate compliance during audits and inspections.
Our mobile-friendly platform enables remote access to training materials, allowing scientists, researchers, and clinical staff to complete training from anywhere. This facilitates collaboration and knowledge sharing across geographically dispersed teams, fostering innovation and agility in biotechnology research and development.
Benefit from dedicated support from our team of biotechnology industry experts, who offer guidance and best practices for implementing and optimizing ISOtrain LMS. Additionally, access ongoing updates to ensure your organization maximizes the value of ISOtrain LMS for biotechnology excellence.
Advance innovation while maintaining compliance with ISOtrain Biotechnology Training Management Software. Built for regulated biotechnology environments, ISOtrain delivers structured learning and validated processes that give you control over personnel training. Designed to meet GLP, GCP and GMP standards, ISOtrain enables biotechnology companies to organize, track and verify every training requirement.
As a trusted biotechnology regulatory compliance software, ISOtrain supports training for research, development and manufacturing teams working in biologics, pharmaceuticals and advanced therapies. Role-based assignments, adaptive learning paths and automated notifications keep employees qualified and ready for inspection.
Request a demo or start a free trial today to experience ISOtrain in action.
ISOtrain supports both large-scale and emerging biotech operations. It simplifies the complex training demands of biologics manufacturing, aseptic processing and batch record management. Supervisors assign courses, monitor completion and receive automatic alerts when renewals or recertifications are due.
Each ISOtrain installation is validated and compliant with 21 CFR Part 11. Built-in IQ, OQ and PQ qualification packages confirm operational integrity and audit readiness from day one. Administrators gain full visibility into team qualifications while maintaining traceable records for internal and external audits.
ISOtrain delivers the structure required by regulatory agencies such as the FDA, EMA and other international authorities that oversee biotechnology manufacturing.
ISOtrain extends beyond standard learning platforms by serving as a biotech document storage LMS that integrates with document management systems (DMS). This integration provides secure access to controlled documents such as SOPs, batch instructions and validation protocols.
Each document follows a defined life cycle with version control, access restrictions and complete audit trails. Personnel receive automatic read-and-understand assignments when a new version becomes effective. All activity is logged to meet 21 CFR Part 11, EudraLex Annex 11 and ISPE GAMP 5 requirements.
ISOtrain functions as comprehensive biotechnology regulatory compliance software, supporting alignment with global standards such as GLP, GCP, GMP and GDPR. Its real-time monitoring and automated reporting tools provide compliance officers and quality teams with clear oversight of training performance.
Dashboards display key metrics including overdue assignments, pending qualifications and audit readiness levels. Reports are generated instantly for agency submissions or internal reviews.
ISOtrain supports biotechnology companies through every operational stage:
Manage laboratory training, experimental safety and data handling assignments.
Track aseptic gowning qualifications, equipment operation and batch release requirements.
Softek Export LLC has provided validated learning management solutions for regulated industries for over 25 years. ISOtrain reflects that legacy through proven performance and direct implementation support.
Every installation includes access to our experienced QA and development teams, who maintain ISOtrain under strict SOPs and an established Software Development Lifecycle.
Here are the answers to some common questions about biotechnology training management software and ISOtrain:
It is a system that manages and tracks training for personnel working in biotechnology and biologics environments to maintain compliance with GLP, GCP and GMP standards.
ISOtrain integrates with document management systems to track document versions, read-and-understand confirmations, and audit trails in full alignment with 21 CFR Part 11 and EudraLex Annex 11.
Yes. ISOtrain supports multilingual use, aligns with international agency requirements and manages training across multiple locations.
Understanding the pivotal role that training and compliance play in the success of biotechnology organizations, our team at Softek Export is dedicated to providing a powerful tool that empowers your workforce, fosters innovation, and ensures regulatory compliance. Join the ranks of leading biotech companies that have chosen ISOtrain LMS as their trusted partner in training and compliance.