GMP Software
Best Practices for Manufacturingwith control, traceability, and safety
With the Qualiex, you can organize processes, centralize documents, and ensure full compliance with GMP standards. From supplier qualification to production control, records, and batch release.
Be 100% compliant with GMP
Document Management and Mandatory Records
Get all the POPs, operating instructions, cleaning procedures, production records, and quality forms organized by process, line, product, and department. Ensure that operators always use the correct version of the procedure, without the risk of performing a process that deviates from the approved standard.
Deviations, nonconformities, and CAPA in a single workflow
Record process failures, labeling errors, parameter deviations, hygiene issues, or contamination. The Qualiex conducts the entire investigation: root cause, impact on the product, and corrective and preventive actions, with a complete history and evidence ready for inspection.
Stress-Free Audits
Plan internal audits, conduct external audits, and record findings, evidence, and action plans all in the same environment. No more spreadsheets, folders, or scrambling for documents when an audit takes place.
Metrics that show whether your factory is truly under control
Track deviations by line, rework, batch rejections, investigation time, CAPA efficiency, and regulatory risks. Get a clear picture of whether your operation is improving or accumulating quality liabilities.
People trained to operate in accordance with GMP
Ensure that operators, supervisors, and technical teams are qualified for each process they perform. Record training, refresher courses, and evaluations, and link everything to the procedures and areas where each person works.
Be 100% compliant with GMP
Document Management and Mandatory Records
Get all the POPs, operating instructions, cleaning procedures, production records, and quality forms organized by process, line, product, and department. Ensure that operators always use the correct version of the procedure, without the risk of performing a process that deviates from the approved standard.
Deviations, nonconformities, and CAPA in a single workflow
Record process failures, labeling errors, parameter deviations, hygiene issues, or contamination. The Qualiex conducts the entire investigation: root cause, impact on the product, and corrective and preventive actions, with a complete history and evidence ready for inspection.
Stress-Free Audits
Plan internal audits, conduct external audits, and record findings, evidence, and action plans all in the same environment. No more spreadsheets, folders, or scrambling for documents when an audit takes place.
Metrics that show whether your factory is truly under control
Track deviations by line, rework, batch rejections, investigation time, CAPA efficiency, and regulatory risks. Get a clear picture of whether your operation is improving or accumulating quality liabilities.
People trained to operate in accordance with GMP
Ensure that operators, supervisors, and technical teams are qualified for each process they perform. Record training, refresher courses, and evaluations, and link everything to the procedures and areas where each person works.
What Our Customers Are Saying
Qualiex is a system where you'll never feel left to fend for yourself, because you'll always have support from the professionals at ForLogic.
The implementation of Qualiex itself brought us a benefit by allowing us to optimize our document database and, as a result, gain control over everything.
The most important factor in choosing Qualiex was the system’s usability, which is excellent and provides everything we need for our management system.
We're familiar with several tools available on the market, but we see what sets Qualiex apart, both in terms of customer service and functionality
See firsthand how Qualiex transforms your quality management
FAQ - Frequently Asked Questions About GMP Software
What is GMP software?
GMP software is a solution that helps companies digitize and organize processes related to Good Manufacturing Practices. The tool centralizes documents, records, deviations, audits, metrics, training, and other information necessary to keep processes standardized, traceable, and compliant.
How can a company ensure Good Manufacturing Practices?
To ensure GMP compliance, it is necessary to standardize processes, keep procedures and records up to date, train staff, control deviations, conduct audits, and monitor quality indicators. Integrated management of these activities facilitates compliance and continuous improvement.
How to manage documents and records required by GMP?
Documents and records must be organized by processes, products, lines, or areas, with version control, approval, and access to the correct information. A GMP system allows for the centralization of SOPs, work instructions, production records, cleaning protocols, and quality forms.
How to Manage Deviations and Nonconformities in GMP?
Deviation management involves recording the occurrence, investigating its causes, assessing its impacts, defining corrective and preventive actions, and monitoring their effectiveness. Digitizing this process facilitates the traceability of investigations and helps reduce the recurrence of problems.
How important are audits for Good Manufacturing Practices?
Audits make it possible to verify whether processes are being carried out in accordance with established procedures and requirements. Documenting evidence, results, and action plans helps the organization identify deviations and ensure that its processes are ready for inspections and evaluations.
What are the benefits of using GMP software?
GMP software centralizes information, improves process traceability, reduces manual controls, and makes it easier to track documents, deviations, audits, metrics, and training. This contributes to more standardized processes and more efficient quality management.
How does Qualiex help with Good Manufacturing Practices management?
Qualiex brings together features for managing documents and records, deviations and CAPA, audits, metrics, and training. With this information centralized, the company can monitor quality processes and maintain organized and traceable evidence for audits and inspections.
Does Qualiex allow you to manage deviations and CAPA actions?
Yes. Qualiex allows you to record deviations, investigate causes, assess impacts, define corrective and preventive actions, and track these actions until they are completed. The history of investigations and evidence also facilitates process traceability.
Does Qualiex help with the management of GMP-related training?
Yes. Qualiex allows you to record training sessions, refresher courses, and team evaluations, linking training to the procedures and areas in which each professional works. This helps ensure that employees are qualified to perform their duties in accordance with established processes.
How does Qualiex help prepare a company for GMP audits and inspections?
Qualiex centralizes documents, records, evidence, audits, deviations, action plans, and metrics, making it easier to access process histories. This allows the company to keep its information organized, traceable, and available for audits and inspections.