Solution by Process

System Planning

isoFiles helps Managers to plan and execute their meetings and audits more effectively. This module automates all steps of the meeting’s lifecycle, such as scheduling, preparation, audit, report drafting & approval, report issuance, and  corrective action monitoring (CAPA).

Audit Management

IsoFiles Audit Management allows Companies to take a different approach to compliance and risk management and support their Audit programs using a computerized, centralized system.

Audits monitor critical processes, identify dysfunctions and help companies to improve overall Quality. An Audit Management System enables efficient management of resources, workflow, data and records associated with internal Corporate Audits at all levels, as well as Audits for suppliers and regulatory inspections from Governoment. In addition, an effective Audit Management System manages and tracks all observational records and the Action Plan (CAPAs) to ensure an adequate resolution.

Controlled Document Management

Document Management tol in isoFiles enables Organizations to improve information control, enhance productivity and drive continuous improvement. Migration to a full-featured digital document system provides a significant time savings in versioning, approvals and distribution management. Documents are available everywhere and in real time.

Customer Complaints / Feedbacks

An effective complaint management system is essential to achieve Company objectives. isoFiles provides the ability to log, respond and investigate Customer claims. Furthermore,  the Complaint processing module provides tracking of trends through automated reporting. With isoFiles, your Organization can centralize its Complaint processing, efficiently manage site-level surveys and electronically process corrective actions.

Knowledge & Training Management

IsoFiles training management provides automated tracking and management of employee training / competencies, ensuring that mandatory trainings are scheduled and monitored until completion, enabling companies to reduce risk, increase employee productivity by improving the management of policies and training requirements across the enterprise.

Supplier Quality

isoFiles allows you to extend your quality and compliance processes to supply chain partners. It offers features and functionality such as Reception Inspections, Supplier Claims, Specification Sheets, Vendor Dashboards, Qualification Workflows, Approved Vendor List, and Non-Conformance and CAPA Tracking results.

Non Conformance / Deviations

isoFiles standardizes data and centralizes quality process content throughout your Company value chain, providing decision-makers with a full picture of Operations. The Compliance Management module provides a common framework and an integrated approach to manage all compliance requirements. 

Corrective Actions

Complaints, Audits, Incidents often result in non-compliance events that need to be addressed in the Corrective Action process. IsoFiles’ action tracking enables organizations to track and manage the Actions implementation process, automate performance verification over time, and provide seamless traceability to related quality processes , including, Risk Assessments Change control and Training.

Processes Management

This module allows you to define your processes, assign the drivers, associated risks/ Opportunities and thus trace the relationships between the processes of your Company.

Change Control

Applications of the change management system include areas such as equipment, process, batch / materials, documents, computer systems, vendors, emergency, labeling and packaging, changes EHS, utilities and validation. isoFiles provides a standardized change control process across the enterprise while allowing flexibility to respond to specific workflow steps, making it a solution designed to be flexible enough to handle all types of changes using of a centralized system.

Lot Management / Traceability

With isoFiles, your batch records are available at all times, making up the history of manufacturing, packaging, Quality Control and Release of each batch. Only one click, makes you able to access to all Data to trace industrial and commercial operations performed on each production batch.

This module contains the detailed standard sections of a batch file in a regulated industry and ensures the archiving, a digital approval flow for each file with the possibility of attaching the reports related to the batch (incidents, validations etc …)