SharePoint QMS for Pharma
Montrium’s SharePoint based QMS provides an easy to deploy and cost effective solution to quality management. Our QMS is composed of a series of integrated SharePoint modules which can be easily adapted to your quality and operational environment. These components interact with each other to provide seamless integration of the quality management process.
- QMS components have been designed to enable easy customization to your existing environment
- Integrated modules and workflows ensure a seamless quality management process
- Use of native SharePoint technology means that the QMS can easily integrate into document and records management environments of SharePoint
- Pre-defined dashboards, metrics and KPIs provide realtime insight into quality management operations and enable trending and targeted troubleshooting
Quality System Document Management
The Quality System Document Management module manages the document lifecycle for all documents that form part of the quality system such as SOPs, Policies, Work Instructions and Forms. This lifecycle includes the review, approval, training and document promotion processes. The lifecycle process also manages biennial review and document obsolescence. Quality system documents can be distributed as digitally signed PDFs via the QA workspace or through the training management process. The QS document management module provides QS document information and references to all other QMS modules.
CAPA & Incident Management Modules
Both CAPA and Incident Modules are composed of a web based InfoPath forms and workflows which manage the analysis, execution and close-out phases of the CAPA and Incident management processes. CAPA can integrate with the auditing module and training module if necessary. A dashboard allows the analysis of incident causes and overall CAPA performance. Both modules can output PDF versions of the CAPA and Incident forms which can be distributed or stored as records.
Change Management Module
The change management module is a collection of intelligent forms, workflows, action lists and record libraries for the management of the change control process. An intelligent InfoPath change control form is used to collect change control information and to manage change control status. The change control module interacts with the CAPA and training modules ensuring proper integration of processes. Once a change has been completed, the change request form is converted to a PDF record using the PDF generation module. The form can then be signed if required using 21 CFR Part 11 compliant digital signature application/device. The PDF form is then transferred to a repository where it is stored as a record.
Montrium’s Training management module is composed of Training plans for the planning and completion of SOP or Regulatory training. These training plans are executed through the use of an automated training workflow. When an employee is allocated to a training session, they automatically receive a task to confirm that they have read the relevant SOP or participated in the training session. A training matrix clearly outlines all required training by role and also tracks which employees have been trained on what. Finally, a Training Record of all training completed, on-going or planned to date for each employee is available online. The training record is populated dynamically from the training matrix and a PDF training transcript can be generated for audit and inspection purposes.
Audit Management Module
The Audit Management module has an integrated set of tools and workflows which can be used to manage whole audit programs or individual audits. This module comes with a series of pre-defined checklists based on current GxP regulations which can be used for different types of audits including:
- Clinical Site Audits
- CRO Audits
- GMP Facility Audits
- Central Lab Audits
- CSV Audits
Once completed, these audit checklists are used to automatically generate the audit report and observations with their respective ratings and can be used both offline and online. The module is also capable of generating standard audit plans, letters and certificates.