Quality Management Modules

The Predisys Quality Management modules are an ideal companion and extension of Predisys quality control solution.

The optional modules are built upon and extends Microsoft SharePoint and Microsoft Office, and provides the users with an easy, intuitive solution for quality management.

The solution supports FDA Title 21 CFR Part 11, but may naturtally also be used in non-regulated industries. 

Predisys Corrective and Preventive Action (CAPA)

Successfully implementing and documenting a Corrective and Preventive Actions (CAPA) is one of the key processes in a manufacturer’s daily quality operations. A functioning CAPA system has important implications on product quality, as well as on compliance and adherence to standards.  However, companies often fail to utilize CAPA’s function as a potent tool for managing quality issues within the organization, instead viewing it as only a cumbersome regulatory requirement.

Predisys CAPA solution helps to turn CAPA into an effective tool for continual improvement throughout the entire organization. A common weakness in poorly functioning CAPA systems is the lack of prioritization of CAPA issues according to the risk they pose, leading to the more important issues getting lost in the flood of less crucial ones. Predisys CAPA solution implements a risk-based categorization for all CAPA requests, ensuring visibility to the most urgent issues.

This visibility is further enhanced through the use of digital CAPA dashboards which show the real-time status of each action item in a highly visible and intuitive format. This ensures that the overall status of the entire CAPA system, as well as of each individual action item, is evident at a glance. In addition, in accordance with ISO9001, Predisys CAPA solution identifies 3 distinct categories of action: Correction, Corrective Action, and Preventive Action.

A major downfall of paper based CAPA systems is that information is easily lost in the records, and is hard to locate. Predisys CAPA solution’s extensive document search capability is applicable to any part of the CAPA flow, including any attachments (such as meeting minutes) and may be used to identify recurring/previous issues which have initiated CAPA action items. It allows trending of CAPA issues according to various key factors such as product type, department, and root cause.

Predisys Nonconformance Management

The identification of nonconformances and opportunities for improvement provides the organization with valuable chances to practice continual improvement. However, an inefficient procedure for managing nonconformances which simply records each nonconformance and directs it to the CAPA system quickly results in the manufacturer becoming snowed under by a huge number of CAPA issues. A systematic procedure for evaluating nonconformances allows only those issues in need of the CAPA process to be directed that way. Other nonconformances may be sufficiently rectified using simple corrections.

Predisys Nonconformance management solution streamlines the process for identifying, evaluating, reviewing, and handling of nonconformances from different sources of quality information. It links quality issues from all processes and departments and offers methodical assessment of nonconformances, resulting in fewer unnecessary CAPA items. The Predisys solution also allows CAPAs to be initiated from nonconformance reports, creating seamless escalation of a nonconformance to CAPA status.

Predisys Quality Audit solution

Several regulatory requirements (e.g. FDA) as well as ISO9000 series place great emphasis on internal auditing as part of continual improvement. Internal auditing systematically monitors and analyzes the organization’s entire quality system for evidence that appropriate and necessary quality system process guidelines have been implemented and that they are being adhered to. 

In addition to internal audits, manufacturers operating in regulated environments may also be required to conduct supplier audits to monitor that a supplier conforms to regulations and requirements.

Predisys offers a quality Audit module as part of the Quality Management Suite which guides and records all the preliminary as well as follow-up work (including all documents and reports such as schedules, checklists and reports) required for managing both internal and external audits.