A Total Solution to Training Management, Analysis & Reporting.
Unique collaborative Software as a Service (SaaS) that that allows the users to create and implement a free training management system in the cloud. The implementation activities include the delivery, maintenance, evaluation, and storage of training content. Also, it allows verifying that the personnel involved in quality and manufacturing activities are properly trained (certified) in all applicable works to be performed related to GxP.
To get free training management system application software, click here.
Powerful Tools and Security Controls (21 CFR Part 11 Compliant) Training Management System software
This application facilitates the identification, execution, documentation, and evaluation of the effectiveness of training activities. Moreover, it brings the mechanism to document the training history records of each trained person and register its signature in a signature log.
It provides the power and capability to improve the Training documentation control activities to comply efficiently with the cGMP’s and regulatory compliance requirements. It is specifically designed for the pharmaceutical, biotechnology, and medical devices industries that want to reach the top level in competitiveness.
Application Software Features
It applies to any department that provides or performs any GxP training (e.g. human resources department, manufacturing, quality, incoming, warehouse, etc).
Besides, the scope of this procedure cover two (2) different scenarios or groups of training, specifically for:
New Hires Resources: Resources that start working for the company for the first time and must be trained with the necessary information to perform their work.
Existing Resources: This group of training is divided into two (2) scenarios, either associated with a work order or not:
New Training: This group considers the training requirements have never been taken and are necessary to perform any GxP task.
Re-Training: This group considers the training requirements that have been taken before, but; maybe refreshed since the last time before performing any current GxP task that even it has been done before, but it needs to be confirmed and documented as re-training.
Create users, positions, areas, curriculums, and courses/training.
Assign training to curriculums and positions
Document the training taken online.
View & manage training taken by users
View pending and expired training of each position and employee.
Create and Manage Companies, Divisions or Branches
e-Signature and e-Approval
Data Import and Export
Integration of other CIQA Application Modules as CAPAs, Risk Assessments, Audits, LIMS, SOPs, etc
Certification – CSV Computer System Validation, 21 CFR Part 11
Training Management System software
User Security and Access Control
One user access with security to their respective access, privileges, & password.
Multi-users access controls and administrative password management for each group.
Company Division Branch Management
A single company division branch.
Support multiple company division branches, merges, splitting of branches.
Basic audit trail of each record individually.
Advanced audit trail functionalities, with searching capabilities and reporting.
Yes, Advanced reports of multiple records and custom reports.
Simple backup functionalities for internal purposes.
Advanced backup functionalities for each branch administrator with reporting.
Secure Collaborative Software as a Service Application that is fast and easy to use.
Data Sharing & Connection from any place at any time. No local servers or installation is required. Training Management System software
All training information related to GxP can be centralized in one secure source of information accessible only by the designated authorized person as defined in 21 CFR 211.25 for pharmaceuticals and 21 CFR 820.25 for Medical Devices.
Interconnected, Private, and Secure Information
Now, you can implement one secure software applications that can grow, replacing over 30 different software in your company with Statistical Process Control and 6 Sigma Tools.
Training Management Software Application in compliance with GAMP4 & 21 CFR Part 11.
It includes an audit trail and cGMP Compatibility perfect to handle all training records taken in each area.
Keep tracking of the most important information used for planning, scheduling, and follow-up pending training. Automate all hard and time-consuming activities that traditionally are handled, documented, and filed manually. Training Management System software
Minimize and prevent human errors, legal disputes, manufacturer’s malpractices, and other risk or adverse situations in which manufacturers may be involved.
To get a free training management system application software, click here.
Over 30 custom application software modules can be implemented soon in different combinations to fulfill your business requirements. CIQA will bring the first consolidated software applications which can replace all available individual manufacturers software related to:
Accounts Receivable & Payable Management
Annual Product Review Management
CAPA Investigations Management
Change Control Management
Cleaning and Sanitization Management
Design Control, Specs, and P&ID’s Management
EHS – Environmental Health and Safety Management
Experimental Projects & Pilot Lots Management
Human Resources – Management (Screening & Recruitment)
Laboratory Microbiology Management
Laboratory of In-Process/Finished Products Management
Recalls, Containments, Shipping Holds, and Releases Management
Regulatory Compliance Submissions Management
Reprocessing / Reworks Management
Retained Samples Management
Returned Goods Management
Risk Analysis Assessment and FMEA Management
Suppliers Management – SCARS Management
Standard Operating Procedures SOPs Management
Validation & Qualification Management
Call us for more information about computer applications specifically designed for the FDA-regulated companies such as the biopharmaceutical and medical devices industries or click here for a brochure of the coming soon applications.
HOW TO AVOID MISTAKES IMPLEMENTING A TMS TRAINING MANAGEMENT SYSTEM SOFTWARE.
We suggest evaluating your current personnel positions and responsibilities to determine which quality management procedures, forms, work instructions, and training requirements are in each area, but, also consider the frequency of re-training.
If you have a small number of employees to be trained, you can initiate a GMP training effort manually using hard paper. In case you need to create or update your cGMP training procedure, you can use a template procedure to accelerate the process to implement a manual Training Management System.
To download a cGMP training procedure template fully editable in MS Word format, ready to fill, and use according to your cGMP needs, click here.
Moreover, you can use free software applications to handle your Training Management System QMS Training necessary.
To get a free training management system software application, click here.
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CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. Rest assured of the safety or being in the right hands.
CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!