CAPA+™ for ISO17025

ISO/IEC17025 compliance just got easier with CAPA+™!

Why CAPA+™? What makes it so unique?

Short Answer: Because one thing leads to another.

CAPA+™ for ISO17025CAPA+™ recognizes that under ISO/IEC17025 compliance, a "Complaint" could also become a "Nonconforming Work Investigation", which could end up also being a "Corrective Action", yet most management systems use separate forms for each of these triggered events. CAPA+™ uses one Multi-Event Form to eliminate redundancy of entries and record the entire chain of events and decisions involved in what began as a "Complaint".

To meet the requirements of ISO/IEC17025 accreditation, a laboratory must deal with the requirements of performing and documenting Corrective Actions, Preventive Actions, Customer Complaints, and Non-Conforming Work Investigations. The typical laboratory rarely encounters the need to deal with these types of events more than a half dozen times each year. As a result of this infrequent need of application, associated procedures and forms are typically less than desired in terms of design, function, ease and understanding of proper use.

Today, we often find accredited laboratories receiving deficiencies pertaining to a poorly defined policy and procedure for dealing with Non-conforming Work Investigations and determinations of customer impact. We even find some laboratories having their corrective action reports rejected due to key elements, such as root cause analysis results, missing or incomplete.

Confusing forms, redundant entries between forms, procedures with lack of detail and the infrequent need of use, can all add up to an unnecessary waste of time and resources, plus the frustration does not make for happy employees.

Quametec, with over 15 years experience developing laboratory management systems in compliance with ISO/IEC17025 has created a unique approach to dealing with these various events that occur which require investigation, evaluation, resolution and, of course, proper documentation.

What is CAPA+™?

CAPA+™ is a unique Auto-Logging System with a cleverly designed, Auto-Expanding, Multi-Event Combo-Form built in Microsoft® Excel® using VBA. It was developed for use in documenting and logging Corrective Actions, Preventive Actions, Customer Complaints, and Non-Conforming Work Investigations without the typical use of multiple forms with redundant entries. It is packaged as a single, auto-install type, executable and/or a zipped directory.

CAPA+™ includes:

  • Control Center: Auto-log and Notification Dashboard System in a Microsoft® Excel® Workbook.
  • Master Combo-Form: Auto-Expanding, Auto-Logging Multi-Event Form used to document component of an "Event". (Corrective and Prevent Actions, Complaints and Non-Conforming Work Investigations.) Each "Event" is kept in a separate workbook for ease in using copies with assessor reports and Corrective Actions dealing with assessment findings.
  • User Instructions with Implementation Procedure: Thirty-three (33) page, ISO type user procedure in an editable Microsoft® Word® format with guidance and text snippets for easy implementation in your management system.
  • Desktop Icon: Installed on the desktop for easy access to the CAPA+ System.
  • Maintenance Contract: Support is provided with via our online user & support group. Plus, direct support via email, telephone and desktop sharing using our GoToAssist service.
  • Training Videos: Three basic training videos are included for use in quickly training your staff. In fact, we thought you may want to see these before you purchase, so we have included them below.

Watch the FREE Introduction and User Training Video's

Requirements:

Any operating system running Microsoft® Excel® and Word®, versions 2007SP3, 2010, 2013 & Office365 (desktop version).

Capability:

CAPA+™ can deal with up to 2000 events in a logbook. Logbooks can be archived at will, and a new logbook initiated. Each “Event” consists of one or more of the following: Corrective Action, Preventive Action, Customer Complaint, and/or Non-Conforming Laboratory Work Investigation, as needed.

Form entries contain references to prescriptive requirements found in ISO/IEC17025:2005, this allows for direct assessment of the requirements by the user.

Detailed user instruction and system implementation procedure is provided in a customizable, Microsoft® Word® format for inclusion into the laboratory ISO/IEC17025 management system. Sections are highlighted in yellow as indication of entries that a user must edit before incorporating into their management system.

The combo-form includes auto-validation with respect to required entries. Users are guided with prompts when they fail to complete the required entries.

Support & Maintenance:

CAPA+™ comes with one-year (1) full support and upgrade service. Our Software Support & Maintenance Service includes:

FULL SUPPORT:

1. Membership to Online User Group, available 24/7. Latest download version is found here, along with a help forum moderated by the creator of CAPA+™.

2. Telephone Support; EDT M-F 9 am to 4 pm at 1-810-225-8588.

3. Desktop Support via Citrix GoToAssist Desktop Sharing Service, for direct assistance resolving any operational issues.


Pricing:

All prices are in US Dollars.
Software is delivered via download
in the 'CAPA+™ User Group' area.

Single Site Use License:
Unlimited Users

$795 USD

Professional Editor Option:
Add to selected License Fee

$500 USD

Support & Maintenance
First Year Free
$125/year USD

Single Site Use License: Allows unlimited number of users as part of a single management system of a single site location.

Professional Editor Option; Adds full VBA code access and permission to modify the program VBA code as desired for functional changes or interfacing with other programs. Use of project code is permitted by the user with this license in other software projects, providing they are not marketed and/or sold as a product which competes with products sold by the Quametec™ Corporation.

100% Satisfaction Guarantee: We know from experience that this system will save you time and money in your ongoing effort to maintain compliance with laboratory accreditation requirements. However, if you are not 100% satisfied with this software, you can return it for any reason within 30 days and we will refund the purchase price.

How to Purchase

Call Quametec™ at 1-810-225-8588 EST M-F (9 am to 4 pm).

We accept Company Checks or Credit Cards (PayPal, Visa, MasterCard, or American Express).

Upon receipt of payment, Quametec™ will provide you with download, support, and installation instructions.

© 2009-2015 Quametec™ Corporation

Last modified: Tuesday, March 1, 2016, 3:18 PM