Contents

Life Sciences and Regulatory Compliance

The Q-Pulse Advancement Framework

The Q-Pulse ModulesLaunchPadCA/PADocument ControlAuditingWorkload Training & CompetenceAnalysis & ImprovementAsset ManagementCustomer ManagementSupplier Management

Our Key StrengthsCA/PA Management Increasing Ownership by Simplifying AccessServices to Support your Validation ProcessQ-Pulse and 21 CFR Part 11

About Gael LtdOur Customers

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Quality Management and Regulatory Compliance are core business processes within the Life Sciences environment. Whether you are a Medical Device or Pharmaceutical manufacturer, a Biotechnology company, or a Blood Services provider, the FDA, the MHRA and the EMEA require that your products, services and processes are provided and performed in a robust Quality-Assured environment that meets standards such as 21 CFR 820 and GxP.

Many organisations approach Quality Management and Regulatory Compliance in a disjointed manner resulting in a duplication of effort, an increase in unnecessary overheads and ultimately a missed opportunity to gain valuable business advantage from such actions.

Compliance management systems that are either paper-based or partially automated result in:

poor employee buy-in and subsequent input into management �system informationcostly, time-consuming manual tasks that drain valuable �Quality resourcesmissed opportunity to gain valuable management insight into the �regulatory compliance status of the organisation

Life Sciences organisations across the globe are turning to the Technology sector for software systems and support that rid them of the bureaucratic burden of compliance, enabling them to meet their regulatory commitments in a streamlined manner, whilst unlocking the latent business improvement opportunities within their management system data. Your organisation need look no further than Q-Pulse.

Life Sciences and Regulatory Compliance

‘We see Q-Pulse as substantial help to us in managing our regulated actions and activities in line with EU GMP requirements....an electronic system such as Q-Pulse will also assist us in maintaining and improving both our procedures and the processes on which they are built.’

Dr Sharon HannahProject Manager

University of Edinburgh, Clinical Reasearch Imaging Centre (CRIC)

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The Q-Pulse Advancement Framework

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Q-Pulse is a fully integrated compliance management solution that covers key regulatory functions such as Auditing, Document Control and CA/PA Management, in compliance environments including ISO 9001, GxP and ISO 13485.

By encouraging ownership of your compliance management system, reducing the bureaucracy of compliance management, and improving bottom-line performance, Q-Pulse will help to drive a cultural shift from compliance as bureaucratic necessity to compliance as an opportunity for future growth.

All of this can be achieved with the Q-Pulse Advancement Framework. These 7 simple steps can make a lasting difference to your organisation, by transforming necessary compliance activities from a costly overhead into a business benefit with proven competitive and commercial advantage.

Capture issues, NCs and complaints, create action

plans and track through to completion all within one

single, integrated system.

Analyse audits and issues, incidents, occurrences and

audit findings and determine the root

cause with detailed graphical analysis.

Improve and grow by identifying trends and concerns, highlighting

costly repeat issues and implementing improvement

projects.

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Define and document the scope of your system, policies and procedures, all with appropriate Document Control.

Publish and distribute your management system to all appropriate personnel, via secure web access, including supply chain.

Create a framework to demonstrate staff competence and capability and therefore train and develop staff.

Verify compliance of your policies and procedures through regular internal audit and prove/demonstrate adherence to legislation.

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‘Q-Pulse is probably one of the most user-friendly systems I’ve used. With its system of interlinked modules, Q-Pulse has helped us in achieving a comprehensive overview of our management system. In addition, the flexibility within Q-Pulse constantly provides opportunities for new improvements and controls within our systems.’

Mark Day Quality Manager

Orthoplastics

The Q-Pulse Modules

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LaunchPad

Designed specifically to � promote ownership and interaction in the QMS.

Provides a shortcut for each �individual to personal and specific information about their compliance actions and activities.

Allows each individual to contribute �to compliance improvement ideas across the organisation, irrespective of their position or seniority.

CA/PA

Quickly and easily � capture deviations and non-compliances from all aspects of the business.

Informs appropriate people of issues �specific and relevant to them and consequently helps avoid repeat occurrences of mistakes.

Encourages a culture of learning and �continual improvement and, in doing so, reduces organisational risk.

Document Control

Allows for the � efficient and effective management of document change from the initial request, through drafting, approval, distribution and publishing.

Radically reduces the � bureaucratic burden of Document Control by as much as 99%.

Extends your controlled documents �throughout the supply chain via a secure web interface.

Auditing

Manages the � complete audit lifecycle from scheduling, planning and conducting, to reporting and following up actions through to conclusion.

Provides the capability of managing �all audits including 21 CFR Part 820, ISO 13485 and ISO 14971.

Provides a central repository for �all audit information and allows organisations to demonstrate compliance on demand with minimum overheads and disruption.

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Workload

Offers a central source to � manage and continually monitor QMS actions throughout the organisation.

The ability to report all actions �completed across the entire compliance management system.

Only relevant information available �to each individual to encourage engagement with, and contribution to, the management system. Training

& Competence

Provides a � complete central register of all employees and their training and competence records.

Enables the planning and scheduling �of future quality promotion events including automatic emailing to attendees.

Allows employee competence gaps �to be identified and addressed in a systematic manner.

Analysis & Improvement

Enables � analysis of all CA/PA, incident and audit findings from every area of the business.

Contains graphical grouping �and trend reports to help identify related issues and improvement opportunities, unlocking benefits for your organisation.

Helps develop an ethos of continuous �compliance improvement.

Asset Management

Provides a � complete central inventory register of your assets.

Maintains a detailed historical record �of all checks including maintenance and risk assessments.

Enables the planning, scheduling �and notification of all future check activities including quality checks and risk assessments.

Customer Management

Maintains a � register of complaints, compliments and correspondence.

Reports � on customer complaint issues collectively or in isolation.

Allows � organisations and customers to work together to develop win/win situations.

Supplier Management

Maintains a � register of current approved suppliers and a historical record of suppliers performance.

Highlights � suppliers deemed unsuitable based on previous performance.

Allows � you to develop win/win situations across the supply chain and enhance customer satisfaction.

‘Corrective and preventive action (CA/PA) violations were cited in 87% of device warning letters last year, leading FDA to remind firms to fully investigate complaints, find the root cause of nonconforming products and document their CA/PA activities.’

The Silver SheetMedical Device Quality Control Reports

Our Key Strengths

CA/PA ManagementThe biggest strength of Q-Pulse can be found in its ability to manage the Corrective Action / Preventive Action (CA/PA) process. This represents our belief that CA/PA Management is the key to a truly efficient and effective management system that adds real business benefit to the implementing organisation. Importantly, CA/PA is also a key area of scrutiny from regulators such as the FDA, with the vast majority of warning letters citing some form of CA/PA violation.

Using our unique CA/PA wizards, templates and workflow process you can:

design data capture wizards based on all your CA/PA recording �requirementsdevelop customised CA/PA management templates based on your �specific process flowsdistribute CA/PA information throughout the organisation in a streamlined �yet systematic manner

This unique approach to CA/PA Management results in increased employee contribution, structured CA/PA investigations and a culture where CA/PA is embraced as a process improvement technique throughout the organisation.

Increasing Ownership by Simplifying AccessImportantly, unlike software systems that are complex, cumbersome and daunting to their users, Q-Pulse has been designed specifically with enhancing the user experience in mind. Key functionality such as a simple user interface, a personalised compliance portal, easy access to both outstanding and approaching actions and full integration with existing emailing systems make Q-Pulse a system that is readily embraced by its users. This results in more people interacting with your management system, thereby increasing both the robustness of its data and the improvement opportunities contained within.

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Services to Support your Validation ProcessGael can assist and support you throughout your validation process by providing the tools and information you require to guide you through the validation mindfield.

Our Validation Project Management service includes on-site consultation with a project manager to help you develop the User Requirement Specification (URS) to match your implementation requirements. Once this consultation has taken place, a clear link will be provided to Gael’s test scripts, helping you make an informed, risk-based decision, about the level of validation testing required for your organisation to achieve compliance with key regulatory requirements.

Gael also provide generic documentation for the validation process - structured templates that will allow you to adapt your internal processes to develop the documents you require. Working in conjunction with independent validation specialists, ECL2 Consulting Services LLC, a validation plan template package was developed, which includes:-

Validation Plan �

Configuration Plan �

Traceability Matrix �

IQ/OQ/PQ �

Validation Summary Report �

Q-Pulse and 21 CFR Part 11Q-Pulse gives organisations all the technical controls required to put a 21 CFR Part 11 compliant system in place, with enhanced functionality for electronic records and signatures, including:

robust passwords �

intruder lock-out �

password expiration �

second electronic signature for record sign-off �

full audit trail on all record creations, editions or deletions �

Together with Q-Pulse’s technical controls, our range of professional services, including supporting documentation and training, provide procedural controls that can help organisations to put the administrative controls in place for a complete 21 CFR Part 11 solution.

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Gael Ltd was established in Scotland in 1995. Since its inception, the philosophy of Gael has always been to offer software solutions and supporting services that facilitate continual improvement.

As the market leader in the design, development and delivery of management system solutions for the Life Sciences sector, we designed Q-Pulse to enable organisations to not only demonstrate compliance against their regulatory commitments but also to present opportunities from within the management system for enhancement and improvement.

Our Customers

More than 300 Life Sciences organisations worldwide use Q-Pulse, from medical device manufacturers including Rocket Medical, to pharmaceutical and biotechnology companies including AstraZeneca and Reckitt Benckiser, as well as blood services providers such as the Scottish National Blood Transfusion Service and Heartland Blood Centers in the US.

About Gael Ltd

‘Prior to Q-Pulse, we managed our Medical regulatory compliance with separate systems, which led to longer audit cycle times and difficulties with employees taking ownership of compliance activities and actions for which they were responsible.

‘Now with Q-Pulse we have an integrated framework, which makes it easier for employees to take ownership of actions, management now have visibility of the amount of compliance activities being undertaken, and getting an accurate picture of our compliance status across the company is quick and easy.’

Les ToddOperations Director

Rocket Medical

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From implementing and maintaining processes and procedures to improving and growing your management system, Q-Pulse offers a comprehensive system to manage all of your compliance needs in all areas of your organisation. Contact us now on +44 (0) 1355 593400 or at lifesciences@gaelquality.com to discuss how Q-Pulse can transform your compliance activities from a costly overhead into a business benefit with proven competitive and commercial advantage.

T +44 1355 593400 │ F +44 1355 579191 │ E info@gaelquality.com │ W www.gaelquality.comGael Ltd, Orion House, S.E Technology Park, East Kilbride, Scotland. G75 0RD

Q-Pulse is a registered trademark of Gael Products Ltd.All rights reserved worldwide. Copyright © 2009 Gael Products Ltd.QPM-74