Compliances

Maintaining compliance with corporate policies and global administrative requirements in heavily regulated industries is essential. As the complexity of these regulatory requirements increases, there's more pressure than ever for companies and their employees to stay compliant. By failing to meet essential regulations, businesses can face hefty fines and legal issues. What's more, noncompliance can have severe consequences on the company's reputation and the lives of its clients. 

With an extensive list of rules and regulations to follow, many professionals are turning to compliance Learning Management Systems (LMS) to stay informed of the most recent changes and updates to compliance standards. ISOtrain is a specialized LMS designed to keep regulated companies compliant and enable them to meet all professional requirements with ease.

ISOtrain's system's central port of command allows you to track qualification statistics, keep personnel training profiles and assign courses to individuals as needed. You can also use our Just In Time (JIT) function with Automated Course Versioning Management to ensure your training requirements are up-to-date.

What's more, our LMS is compliant software with features like robust security management, electronic signatures and audit trails. One key element is that ISOtrain automatically tracks all activities and operations for regulatory auditing purposes. 

ISOtrain is compliant with various regulations and governing bodies in the United States and abroad. We follow a strict Software Development Lifecycle (SDL), and our in-house Quality Assurance (QA) department tests and validates all of our products before they enter the marketplace. We supply companies with pre-validated solutions and validation services. 

Request installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocol packages to ensure your team members correctly configure your new LMS. You can also enlist the support of our QA department to set up a validation program or plan an emergency response to a critical compliance issue. Our team is fast to respond and ensures strict confidentiality. 

ISOtrain is committed to assisting professionals in staying current on the most recent regulations and requirements. Our system is compliant with:

• 21 CFR Part 11 Compliance (FDA): This FDA compliance regulation allows businesses to use electronic signatures and records instead of paper ones as long as your LMS has the necessary features. A 21 CFR Part 11-compliant LMS must allow regulatory auditors to track all data and operations through audit trails. FDA-compliant software should also use a secure hosting platform, have electronic training records and require electronic signatures before every significant operation. 

• (GDPR) EU Regulation 2016/697: ISOtrain also complies with the European Union (EU) General Data Protection Regulation (GDPR). The GDPR protects EU citizens' privacy and personal information, and it applies to companies that operate within the EU or undertake business activities there. This regulation requires all businesses to state why they're collecting a user's personal information and how they intend to use it. The user portal functionalities in ISOtrain keep our LMS GDPR-compliant by allowing users to give their consent for data collection or specify their privacy preferences. 

• EMA: TheEuropean Medicines Agency (EMA) organizes inspections of businesses that develop, market, manufacture and sell medicine for human or veterinarian uses. ISOtrain ensures companies stay compliant by using specific features that allow EMA professionals to monitor and evaluate employee training history and other system operations. 

• EudraLex (Vol. 4 Annex 11): Volume 4 of EudraLex outlines guidelines for good manufacturing practices (GMP) for human and veterinarian medicines. There are 19 Annexes within Volume 4, and Annex 11 refers explicitly to automated systems. Annex 11 states that a computerized system that replaces a manual one should be high-quality and low-risk. To comply with EudraLex, ISOtrain includes risk-management operations throughout the SDL. What's more, we offer validation services with all products, and our systems feature built-in security checks with electronic signatures.

• ISPE GAMP 5: ISOtrain closely follows the Good Automated Manufacturing Practice (GAMP) guidelines from the International Society for Pharmaceutical Engineers (ISPE). The GAMP 5 provides practical instruction for how computerized systems in regulated industries can comply with current requirements while facilitating technological advancements. GAMP 5 also advises businesses on how they can improve the quality and efficiency of their computerized systems while decreasing overall costs. 

Working with compliant and validated computerized systems is essential for highly regulated industries. An LMS must have a range of specialized features to comply with U.S. and EU regulatory bodies, including:

• Audit trail: A compliant LMS like ISOtrain will track all operations and critical actions. Regulatory audits require your business to provide data tracking for quick and efficient evidence collection. This tracked data is called an audit trail, and it includes all Learning Management System compliance training courses, registrations, employee log-ins and changes to course scheduling. A compliant LMS will also record information about who did an action and the date they completed it, even if it was automatic. 

• Electronic signature: To ensure the system and company data are secure, a compliant LMS must require an electronic signature whenever an individual makes a change or completes an operation. The electronic signature ensures that only authorized personnel with a valid username and password can complete certain actions. The audit trail works alongside the electronic signature by recording what action the individual is trying to carry out, who the individual is and when they signed in. 

• Secure hosting: A compliant LMS must guarantee a secure hosting platform to protect the business and its users. The system needs to use an encrypted connection to protect its data and have ample security features at the server, database and user level. What's more, the LMS should offer a procedure for recovering data in the event of an unforeseen incident. 

• Validation: A computerized system that complies with national and international regulations will have procedures in place to guarantee the quality of each new software update. An internal Quality Assurance (QA) department can test and validate all versions of a product. Businesses should also have the opportunity to validate new versions of the system to ensure compliance and reliability. 

At Softek Export LLC, our ISOtrain developers work in a highly regulated environment to ensure that ISOtrain is compliant software. In addition to fulfilling all four of the above requirements, our systems also have numerous valuable features, like:

• Central point of command: Organize your team and set which employees can complete specific operations from one convenient platform. You can also assign self-led courses, schedule instructed training sessions and send reminder emails for automatic enrollment. Monitor employee progress, keep records of qualifications and notify your team about any changes to compliance regulations. 

• Configurable systems: ISOtrain offers straightforward functionality right out of the box to streamline your training process. You can also change your theme by selecting specific colors or writing creative messages to your employees as they complete training. Translations in over 11 languages provide further ease of use by supporting a global workforce. 

• Online training opportunities: ISOtrain features an Online Training Portal that allows personnel to claim ownership over their learning journey. Our system empowers employees by enabling them to manage their qualifications, self-register for training courses and plan for future qualification opportunities. 

• Paperless reporting: ISOtrain makes tracking employee progress effortless. Examine past, current and future statistics and use that information to produce reports for further analysis. Easily monitor employee progress and assign specific courses as necessary.

• E-learning: Our web-based LMS allows employees to access training materials wherever they are. Provide your team with articles, audio programs or video content to assist e-learning and ensure employees reach their qualifications quickly. You can also create assignments to assess their main takeaways and measure knowledge transfer. 

• 3rd party integration: Use ISOtrain to integrate your qualification data with third-party applications, including Document Management Systems (DMS), Customer Management Systems (CMS) or Human Resources (HR) programs.

• Compliant features: Our system's robust security features, electronic signature requirements and comprehensive audit trails ensure you stay compliant with U.S. and EU regulations. ISOtrain tracks and records training data, user details and completed operations. 

At Softek Export LLC, we're committed to providing highly regulated industries with an effective, reliable and validated Learning Management System. ISOtrain is the best way to schedule, monitor and update your business's training process. We ensure your company stays fully compliant with both U.S. and EU-based regulatory requirements, making it perfect for pharmaceuticals, cosmetics, biologics and other industries. 

We're proud to say we've been serving various regulated industries for over 25 years. Our knowledge and experience have allowed our software to be in use longer than any other LMS in the market. ISOtrain has provided countless businesses with the essential tools to train their team, analyze qualification statistics and stay up-to-date with compliance regulations. 

Ready to empower your workforce with a professional compliance training and learning management system? Experience the ISOtrain difference today. Our team is on hand to answer any questions you have and provide additional information on our products. Contact us to receive a free demonstration of our software and a quote for your company.