Isotracker Quality Management System Qms Overview By Lennox Hill Ltd 316p3z

isoTracker Quality Management Software

SOLUTION OVERVIEW

isoTracker • Designed for small & medium sized enterprises (<500 employees) – Easy-to-use, quick to set up and competitively priced – Meets requirements of ISO 9001:2008

• Web-based software – Nothing to install, accessible through any web browser – Security guaranteed with encryption and back-ups – Upgrades are included and happen automatically

• Quality Management System – Control Documents, Manage Complaints, Schedule & Run Audits, Assess Staff for Competency – See same information from any location – Full record of each activity

Lennox Hill Ltd – Vendor Information • Parent company: Lennox Hill Ltd – – – –

In business since 2005 Privately owned company headquartered in London, UK Technical team in Madurai, Tamil Nadu, India Marketing team in Cape Town, South Africa

• isoTracker quality management software – Launched in 2007 – Over 500 paid s as of December 2012 – Worldwide customer spread from Adelaide (Australia) via Abu Dhabi (Persian Gulf), Johannesburg (South Africa), Nottingham (UK), Dublin (Ireland), Newark (USA), Houston (USA) to Denver (USA) – New updates are included in subscription and rolled out every 5-6 months

Modular application – Key Features Document Control

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Version control Electronic approval Restrictive access Full history Archive old versions

Define jobs Identify Competencies Build & run tests CAPA Re-evaluate

Complaints Management

Competency Testing

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Internal, Process or Supplier Saved Standard Checklists Schedule Recurring audits CAPA Full history

Audits

Record & Track Investigate Root cause analysis CAPA Inform complainant

Ease-of-Use • • • •

Designed for non-techies therefore simple and intuitive Simple set-up that requires little training Exceeds requirements of ISO 9001 & ISO 14001 Gradual increase of features as we request them

Technical • • • •

Webinar training which can be repeated at each renewal Email with response within 1 business day Extensive online tutorials Extensive help documentation

Data safety and security • Documents and key information encrypted – SSL encryption can also be added

• Automatic daily backups – All isoTracker data is backed up every day

• Documents can be ed onto disk – Data can also be extracted into Excel

• Proactive vendor security team – Monitors security bulletins & updates servers as required

Pricing • Flat annual subscription fee – Starting at GB£ 317 (US$ 539) for 1 module with 5 s (+ system ) – Equivalent to GB£ 0.14 (US$ 0.25) per per day

• No set-up fees and no training fees • Software upgrades included

• Email included

The real cost of software Competitive Software 40%

95%

Software Licence

Subscription Fee

5%

Implementation

All Other Costs

25% Hardware IT Staff Maintenance & Training

15% 10%

10%

HIDDEN COSTS

Return on Investment (ROI) • With an implementation time measured in hours rather than days or weeks for other software we will experience with isoTracker a very hard to beat Return on Investment • Their ROI calculator can be requested on http://www.lennoxhill.co.uk/-us.html and will help us

demonstrate the ROI for using isoTracker

FEATURE DETAILS

Document Control •

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Automatic Version Control ensures that only the latest version of a document is viewable. Prior versions are automatically archived Electronic Approvals with recording of exact details of the approver plus date & time and comment at approval Restrictive Access ensures that viewing, editing, approving of documents and archive access is assigned on a “need to basis” Automated Routing ensures that document cycle time is reduced at each stage until publishing Audit Trail provides a detailed, time stamped, identified history of all activity on a document

Document Control Flow

Customer Complaints •

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Log Complaint using pre-loaded record of customers, products, process & suppliers. Assign severity level and attach documents Review & Assign Complaint comparing current complaint to prior complaints of similar characteristics. Assign responsibility Investigate complaint by asg tasks to individuals with required due dates . Record Non-Conformance and Root Cause with Importance level Issue CAPA requests with reply due dates. Automatically escalate if due dates are missed. Accept and close once satisfied with required action and proof of action Close Complaint by asg to independent individual. Warning message if CAPA request still open

Audits •

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Create Internal, Process, Supplier or Third Party Audits Construct Checklists using saved checklists or build from scratch Schedule Audits and view calendar of future audits by Auditor. Issue reminders prior to audit start date Scoring flexibility with /Fail or flexible Numeric Grading rules Run Audit online by entering results directly into the checklist. Alternatively, extract checklist and results Identify Non-Conformance and Root Cause with importance level. Assign CAPA requests with required due dates. Automatically escalate if due dates are missed. Do the Audit Report and select an Audit Opinion. Solicit from the auditee

Competency Testing •

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Create Competencies and assign them to Job Roles and Individuals Build Tests for each Competency. Tests may be various multiple choice or answer entry Schedule Assessments and select the relevant tests for the required competencies. Notify trainee prior to start of assessment Run Assessment directly from the trainee’s . Tests results automatically calculated with overall assessment graded by Trainer. Identify Non-Conformance and issue CAPA requests with reply due dates. Automatically escalate if due dates are missed. Keep Assessment Records and schedule follow-up assessments

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Named s each with a unique name combination feature that automatically re-assigns and emails new Lockout when the incorrect is used a specified number of times Assign Responsibility to each based on whether they should have istrative roles to the various modules Encryption of all the important information

CUSTOMER COMMENTS

What do other customers say… Keeping on top of Document Control was always difficult and time consuming - but not anymore! The Queen Elizabeth Hospital King's Lynn NHS Trust, UK Unlike other products we have looked at isoTracker is not complicated by unnecessary layers of functionality and has proved easy to tailor to suit our own work practices. Murphy & Son Ltd, UK isoTracker has provided us with an easy-to-use and cost effective document management system, replacing a cumbersome paper-based system. We believe that this will allow us to maximise the benefits of our management systems, and ensure documentation is consistently maintained in a up-to-date state. Sichem L.L.C., Abu Dhabi …important to maintain tight control over policies in a dynamic and intense clinical environment…becomes simple when documents are managed by reliable, very easy-touse and well ed software, such as isoTracker. Flax Bourton Public Mortuary, Bristol, UK

Learn More about isoTracker

• Get an instant Free 60-Day trial – No obligation, no credit card required. – Free including Web Demo – now at http://www.lennoxhill.co.uk/salesform/confirm.html

• More information: – Online Demos: http://www.lennoxhill.co.uk/online-demonstrations.html