At Softek Export LLC, we create validated Learning Management Systems (LMS) for regulated industries. Our LMS, ISOtrain, improves how regulated companies organize, schedule and manage the employee training process. ISOtrain is fully compliant with both company and regulatory requirements, making it the ideal choice for companies working in pharmaceuticals, food production, cosmetics and other regulated industries.
The training requirements for these industries are complex and changeable. Ensuring you and your team meet the most current compliance standards is essential to avoid warning letters and costly fines. Time-sensitive compliances can be challenging to juggle alongside product updates and staff management, but ISOtrain can solve this. We keep your company compliant with corporate policies and regulatory agencies regardless of what changes your business experiences.
Softek Export LLC is a privately held company located in Miami, Florida. Softek is an agile organization that has developed software and services for a variety of applications like: Training Management, SOP Circulation/Approval, Project Cost Tracking, Direct Labor Distribution, Manufacturing Control, and Instrument Calibration.
We use our extensive experience and knowledge to provide various regulated industries with efficient, versatile and validated training software configured to their specifications. ISOtrain allows companies to stay on top of employee training requirements with ease.
We service various regulated industries to enable them to stay compliant in their training, including:
Food industry: LMS for food production allows companies to keep employees compliant with the latest food safety requirements. Integrating training and exams into an LMS like ISOtrain can streamline the process and ensure your employees understand the most current regulations.
Pharmaceuticals: Pharmaceutical professionals must remain compliant with requirements that ensure the safety and efficacy of drug manufacturing. A Learning Management System for pharmaceutical companies takes the guesswork out of compliance by providing a single portal for managing employee training and analyzing qualification statistics.
Medical devices: Medical devices must comply with eight separate regulatory categories. An LMS for medical products and devices assists employees in becoming experts in these specific regulations while ensuring they stay up-to-date on any changes.
Radiation-emitting electronic products: The manufacturing of radiation-emitting electronic products is heavily regulated. If the product is also a medical device, it must comply with the regulations within that industry as well. Learning Management Systems for manufacturing these products are essential for remaining compliant with changing requirements within the industry.
Biologics:Biologics encompasses businesses that create medicinal products from blood, organs and other living organisms. Vaccine manufacturers also belong to this industry. ISOtrain allows employers to stay current on the numerous compliance regulations their personnel must meet.
Animal and veterinary: Veterinary Learning Management Systems provide e-learning on this industry's best practices. The systems support you as you train personnel on regulations regarding animal products, including food, medicine and devices.
Cosmetics: A diverse workforce combined with various projects can make training and continuous education a challenge. A Learning Management System for the cosmetic industry streamlines the process and ensures each employee is knowledgeable.
Tobacco products: A specialized LMS for tobacco companies can provide courses and training resources to ensure your business stays compliant in this heavily-regulated industry.
ISOtrain is compliant with U.S.-based and international regulating bodies. Our Quality Assurance (QA) Department monitors and validates all of our products before we release them to the marketplace. We offer validation services, including installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocol packages. Our QA Validation Services Team can offer consulting services for you to establish a validation process, respond to emergency compliance situations and provide IQ/OQ/PQ solutions.
ISOtrain is compliant with the following governing bodies and regulations:
21 CFR Part 11 Compliance: Part 11 of Title 21 of the Code of Federal Regulations (CFR) states that electronic records and signatures are a reliable alternative to paper records. For an LMS to be 21 CFR Part 11 compliant, it must have specific features to ensure all data and operations are trackable.
"GDPR," EU Regulation 2016/679: The General Data Protection Regulation (GDPR) is a European Union (EU) law that protects the data privacy of EU citizens. To comply with GDPR, companies must use plain language to say why they're collecting a user's data and how they plan to use that information.
EMA: The European Medicines Agency (EMA) overlooks and evaluates medical products. The EMA also coordinates inspections to ensure companies comply with the EU standards when developing, advertising, making and selling medicines.
EudraLex (Vol. 4 Annex 11): Volume 4 Annex 11 consists of specific guidelines for the use of electronic signatures and documents within industries developing, manufacturing and distributing medicinal products.
ISPE GAMP 5: The Good Automated Manufacturing Practice (GAMP) sub-committee of the International Society for Pharmaceutical Engineering (ISPE) advises companies on how to create compliant LMS and other computerized systems.
ISOtrain has been a global LMS leader for over 25 years. Our robust, scalable and secure software includes extensive reporting options. We also maintain an in-house Quality Assurance Team for validation and follow a strict Software Development Lifecycle (SDLC). To ensure ISOtrain meets the highest quality standards, we are also accustomed to hosting vendor audits.
We're the leading choice for LMS in heavily regulated industries. ISOtrain has been in use for longer than any other product in the market, and we've provided countless companies with the resources to train personnel, track training data and analyze statistics. What's more, ISOtrain provides data tracking so that you can stay compliant in the event of a regulatory audit.
By maintaining complete electronic LMS transactions, you can quickly provide auditors with their requested information. If your organization purchases another company, we can convert the purchased company's training records from your LMS. In addition to these many benefits, the main features of ISOtrain include:
Central management portal: Manage the entire lifecycle of your training program from one easy-to-navigate central point of command. Assign specific courses to employees, monitor their progress and track their qualifications. You can also use this portal to instantly notify employees about any changes to compliance requirements.
Mobile applications: Our Android and iOS mobile features allow you to use our LMS wherever you are. Control the reporting, training, qualifications and assessment functions entirely remotely.
Configurable functionality: Our flexible software allows you to add or remove features as your company's business needs evolve.
Continuous development: Our Quality Assurance (QA) department executes software testing and validation for continual product improvement.
Efficient compliance: Our LMS makes it easy to stay on top of changing compliance requirements and regulations. The automated system allows your company to standardize training procedures and update educational material.
Regulated industries require a specialized LMS to streamline the employee training process. ISOtrain is a Learning Management System that enables your employees to comply with corporate and regulatory requirements. Ready to partner with the leading LMS, ISOtrain?Visit our solutions page today to learn more about our products, or contact us for a free software demonstration.