Category: Quality Assurance Consulting

  • JobBOSS Certification under ISO 13485 and FDA QS 21 Parts 11 and 820

    Software like JobBOSS is an integral part of many shop processes.  While it may not be as ‘visible’ or ‘apparent’ in many situations, it is often key to scheduling, controling, recording, and maintaining many of the results of work completed in various shops.

    As a result, regulatory agencies like the FDA and ISO require proof that the software is in compliance with regulations like FDA Quality Systems regulation 21 Parts 11 and 820 and ISO 13485 if the products from the machine shop are used for registered industries.  Your surveillance audits, and the client audits that are requested by customers to ensure that the supplying shop is in compliance, may include the software such as JobBOSS.  The audit pertains to the actual use of the software in the shop, including installation, maintenance, and upgrade processes.  The auditor looks for proof of due diligence with regard to the above processes and requires proof from the audited organisation.  In software, this proof generally takes the form of screen shots showing unchanged behaviour in major functionality after upgrades have occurred, and various supporting reports and documents.  This constitutes a Quality Assurance program for the software.  The auditor examines these proofs and evidence of the Quality Assurance program to provide a Pass on the audit.

    If you have a concern about passing an audit for JobBOSS or have had an audit that has resulted in an NC rating, take a look at our service  to see what can be done and how it can help you pass an audit.  Contact us to follow up.

     

    NVP has generated and maintains a regression package for JobBOSS to help organisations pass the audit.  Since it is already built, the cost is restricted to customising it for your situation and gathering up the artifacts as proof.  The cost of updating is borne by NVP.

  • Let a Quality Assurance Manager Fix It

    Are you struggling with your company’s data management system? Are you and your team, customers or management frustrated with your processes? Are you having challenges delivering on time or scaling your sales cycle to realistic delivery dates? If you are losing customers, talent and credibility because you are struggling to manage your financial data, inventory, CRM data or other software that’s critical to your company’s success, it might be time to think about hiring an external Quality Assurance Manager. (more…)

  • Reduce Business Risk with QA

    The software your business relies on to operate successfully is crutial to the success of your company. Software RISK (a potential problem that may occur due to lack of information, control or time) is something that should be minimized wherever possible when it comes to your daily business operations.
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  • Make Better Business Decisions With the Help of QA

    When it comes to your company’s inventory management system and financials, is your information readily available so you can make key business decisions (with confidence)? If you can’t easily and honestly answer yes – perhaps it’s time to look at the process(es) with which you and your company manage data. This data could include monthly sales figures, accounts payable/ receivables, sales management data, purchase order tracking, contact database, employee information and more. (more…)