CAPA-centered quality software for medical devices

The AcQualis™ application handles CAPA (Corrective And Preventive Action) events in manufacturing, for compliance with ISO 9001/2000, FDA and CE medical device requirements, including 21 CFR Part 11 requirements for electronic documents.

Key Benefits

	Manages CAPA (Corrective and Preventive Action) forms
	Manages engineering changes
	Manages document and bill-of-materials corrections
	Manages inspection logs
	Interacts with ERP inventory and bill-of-materials

The AcQualis™ system is focused on...

	Addressing the special significance of CAPA for FDA-regulated device makers, leading quality-management teams to spend more focused time on CAPA, generating clearer, fuller and more complete documentation.
	Enhancing team collaboration - This system is the only one we know that captures people's interactions so that in the process of resolving an issue as a team they create a fully compliant CAPA document, saving time and money.

Presentation

Click here for a presentation that focuses on the unique advantages of Commonwealth Software’s AcQualis™CAPA application:

	CAPA Presentation (Acrobat .pdf, 914KB)
	CAPA Brochure (Acrobat .pdf, 626KB)

Product Description

AcQualis™ is a collaborative application that gathers critical quality-related information from throughout the organization, contributed by people in a variety of roles. It interacts with the company’s ERP system (Enterprise Resource Planning). 

More specifically, the program manages a database made of several different types of documents connected with Corrective and Preventive Actions: (1) Review Notification (RN) forms - forms that trigger a committee review, (2) Repair forms - handled as a subtype of RN, (3) Engineering Change requests / Engineering Change orders, (4) Corrections to Bills-of-materials and other documentation, and (5) Inspection Log entries. The central CAPA document (RN) is more than just a non-conformance form - it is not just negative - our application also functions as a multi-ported, instantly accessible suggestion box, which everyone in the organization is empowered to use, whenever there’s an opportunity to identify a potential improvement in a product or process. 

Interlocking forms - Review Notification forms, Engineering Changes and Correction forms have an interlocking relationship: A Review Notification cannot be closed until its dependent Engineering Change(s) are closed, along with other required actions. An Engineering Change can’t be closed until its dependent Correction(s) are closed.

Correction forms are also used alone to implement a simple but powerful workflow solution for correcting drawings, bills-of-materials and other critical documents.

Focus on collaboration - The application's distinctive features all contribute to enhance collaboration; together these features present an exceptionally rich document model:

	Threaded narratives - The threaded narrative fields work like a “blog” or threaded discussion, and identify the contributions of each participant with name and date, showing vividly how the issue was tackled and resolved. Users compose comments in a separate window where spell-checking is available.
	Rule-based document life cycle management - A document passes from one phase to the next in its life cycle when the STATUS is changed, Configurable document life cycle means that status identifiers are defined using a Status List Management screen. Each change of status is validated using a set of Status change validation rules. Rules are developed using a Rules Management screen.
	Configurable checklists - Checklists are managed both at the document level by clicking the Required box and system-wide using the Checklist Management screen. Name and date are recorded for each checkmark made.
	Document-style concurrency – several users can view a document while only one may edit it – read/only users are notified when the document becomes available for editing.
	Attached Documents - Documents from any Windows application (Word processing, spreadsheet, image, CAD) can be attached in two stages: an active stage where they are editable in place from any workstations that has the host application, and an archived stage where they can be read but not changed.
	Indelibility - Central to the design of this application is the need to make it behave like indelible “ink on paper,” to disable the computer’s normally-desirable ability to allow a user to change a document without leaving a trace of the document’s state prior to the change. CAPA uses many innovative methods to apply this constraint and to communicate the state of the data to its users.

Architecture - AcQualis™ is developed using the Windows Multiple-Document Interface (MDI) and ADO database connectivity. The CAPA data is kept in the form of a secure relational database (MS SQL Server 2005).  The ERP data comes via ODBC or OLEDB from the ERP system’s native database platform. Everything that persists in the application is stored in the relational database, which handles the mechanics of sharing data among multiple users and allows unlimited reporting and analysis using the CAPA application’s own reports or such external tools as Crystal Reports, Quantrix, Cognos, Microsoft Access, Excel.