Governance, Risk and Compliance Blog

Pharmaceutical development company Nanopharm opts for EQMS by Qualsys

Posted by Emily Hill on Thu, Aug 03, 2017

Qualsys are delighted to welcome pharmaceutical development company Nanopharm as a new EQMS customer. Nanopharm will be implementing a full suite of EQMS modules to support scalable quality and compliance management systems. 

Nanopharm is the leading provider of tailored analytical and product development of orally inhaled and nasal drug products (OINDPS). It will be using EQMS to manage all their documentation, audits, corrective and preventive actions.

Susanne Durie, Head of Quality at Nanopharm, said the team are excited to see how the system will grow within their organisation. "We’re looking forward to exploring the software and finding out how we can make the most of it." 

EQMS by Qualsys is the preferred solution for many pharmaceutical development companies, as the software helps connect data, processes, business systems, assets and people in a central, unified solution. The system helps organisations to meet standards such as ISO 17025, ISO 13485 and ISO 14971, and robust controls required for MHRA and FDA.

Welcome cake sent to Nanopharm


Alex Swan, New Business Manager at Qualsys, has seen many life science and medical device manufacturers discover more hidden value in EQMS during the implementation process.

"The Qualsys implementation team take a best-practice approach to implementing EQMS," Alex said. "This is the best opportunity most quality professionals get to take a deep look at their processes and, with our help, make them more streamlined, efficient and compliant.

"After the implementation process, not only do our customers see considerable cost savings, they find their organisations are more agile and faster to adapt to change. We help other businesses to become fitter, faster and stronger.

EQMS KPI Dashboard

For more information about using EQMS for pharmaceutical, medical device and lifescience quality management systems, download our customer case studies here. 

Download EQMS Case Study Booklet

Tags: FDA, ISO 13485, ISO 17025, MHRA

5 Must Attend Quality Management Events in 2015

Posted by Alastair Atcheson on Wed, Jan 07, 2015

New Year, New Changes

The quality management landscape is set for some dramatic changes in 2015. Namely, the introduction of ISO 9001:2015 will impact how organisations operate worldwide. Quality professionals must also stay on top of the latest technological advancements to stay ahead of the curve. Why not make it your New Year’s resolution to book your place on these essential quality management events now?

 

1. The 2015 CQI Conference

 

 

When: 15th April 2015

Where: The King’s Fund, London, UK

Why: As CQI’s annual summit on all things quality, this ever-expanding quality management event is not to be missed. Over 97% of delegates at the 2014 event felt they learnt practical advice that they could implement within their business. Open to leaders and managers, this conference will focus on how you can drive your organisation forward with strategic use of quality, excellent organisational leadership, assurance and improvement.

Overview: Through a combination of plenary and breakout sessions, quality professionals will share their knowledge and insights into the upcoming QMS Standard changes. Future-proof your business and maintain a competitive advantage. Attend and you will:

  • Discover how quality operates in world-class businesses 
  • Be inspired by thought-leaders and inspirational speakers
  • Analyse current trends and topics and probe into the future of quality management 
  • Develop practical skills from specialist workshops and breakout sessions
  • Optimise your time with a tailored conference programme 
  • Gain invaluable personal and professional experience
  • Network with other quality professionals and senior industry leaders
Early Bird discount is valid until 30th January 2015.


Click here to attend this quality management event now.


2. Quality in Social Media

quality management social media

When: 19th February 2015

Where: Harben House, Milton Keyes, UK

Why: Manage or work for an SME and want to develop your business’ online reach? Then this event is for you. Led by Ellen Willoughby, director of her own consultancy firm All About Quality, you will learn how to build and develop online relationships that can lead to more work coming directly from the Internet.

Overview: This intimate, in-depth seminar will focus on the practical tools and tips necessary for enhancing your social media presence and show you how to:

  • Improve your social media strategy
  • Optimise your online output for your business
  • Develop business connections through social media
  • Nurture relationships with leads and customers


For information and bookings email hagarwal@crayola.com.


Twitter: @allaboutquality

 

3. The IRCA Briefing: ISO 9001:2015

Presented by IRCA’s Technical Manager, Richard Green

 

iso 9001 event

 

When: April 2015

Where: TBC

Why: As part of its ongoing coverage of the developing ISO 9001:2015 standard, Qualsys Ltd. hosts this fundamental seminar covering all the key changes in the Final Draft International Standard (set for release in March 2015).

Presented by IRCA’s Technical Manager, Richard Green, the event will provide you with the insight you need to drive your organisation towards ISO 9001:2015 certification. By answering common questions asked by those within the Quality industry, the event will empower quality professionals to take ownership of the standard and generate process efficiencies.

How will the role of management change and how can they demonstrate leadership within the organisation? How can your organisation demonstrate the appropriate level of ‘risk based thinking’? And how does analysing the ‘context of your organisation’ help provide the right focus, approach and balance to the different elements of your quality management system?

Keep up to date on the developments of this must-attend quality management event by signing up to the Qualsys newsletter.

 

4. World Conference on Quality and Improvement

 

World Quality Conference

 

When: 4-6th May, 2015

Where: Nashville, Tennessee, USA

Why: With 95% of 2013 attendees recommending the event, the 2015 World Conference on Quality and Improvement goes far beyond a normal conference. Experts show you how to improve efficiency at your company, while the event itself offers countless networking opportunities.

Overview:  Over the course of three days, hundreds of sessions and workshops will provide hands-on learning and real-life application of quality theories. Foster a culture of innovation and quality at your business by attending and learn how to:

  • Innovate by combining quality and creativity
  • Sustain a leading culture of quality at your business
  • Create an innovative working environment
  • Mitigate risk and embrace new changes
  • Benchmark your company against others with live case studies
  • Apply theory and fundamentals in a non-traditional environment
  • Prepare for developments in the globalised world of quality 

 

Early Bird tickets end 13th March 2015.

Attend this quality management event now.

 

5. ISO 9000 World Conference

 

ISO 9001 Event

 

When: 9-10th March 2015

Where: Houston, Texas, USA

Why: In its 23rd year, the ISO 9000 World Conference brings together leaders in the world of ISO 9000 and QMS Standards. The conference provides invaluable insights from the people making and implementing the changes to QMS Standards. Keep pace with the revision process and learn how to comply with the revision to ensure quality is at the forefront of your organisation.

Overview: In a comprehensive schedule over two days, speakers will discuss changes and probe questions into ISO 9000 and QMS Standard revision and how this will affect your business. The different ISO tracks will enable you to:

  • Separate fact from fiction when it comes to the ISO 9001: 2015
  • Build customer intimacy through integrating innovation
  • Take charge of the changes by implementing self-assessment
  • Understand new changes via different case studies
  • Interact with other leaders during speed networking opportunities

 

Early Bird discount ends 5th February 2015.

Click here to attend this quality management event now.

 

Want more?

Why not download our ISO 9001:2015 toolkit detailing all the essential changes in the upcoming revision?

 

Auditing iPad

 

 

 

 

Tags: Quality Management Software, ISO 9001:2015, FDA

ISPE GAMP Forum increasing dialogue in Pharmaceutical Regulation

Posted by Ben Saxton on Tue, Dec 09, 2014

Qualsys recently attended the International Society for Pharmaceutical Engineering (ISPE) GAMP Forum, an event organised to increase dialogue and practical guidance between those involved in pharmaceutical regulation.

Michael Ord and Ben Saxton both attended the event to further their Pharmaceutical sector knowledge and understand the issues many of our clients face. As a vendor organisation we were pleasantly surprised and grateful of the open culture and welcoming nature of the forum.

Common issues within pharmaceutical compliance were shared with other members of the forum with a shared goal of improving practice for all. The November event was held at the recently opened and incredibly impressive Waters Mass Spectrometry facility in Wilmslow. The facility is an inspiring space to hold a forum and all delegates enjoyed the fine catering provided.

WW

The forum consisted of a number of presentations all delivered by an expert of their field as well as break-out sessions where a number of different topics were debated.

Trevor Simmons of ZigZag started events with a thought-provoking presentation on the use of Cloud solutions. We were all in agreement of the advantages that Cloud could offer but definitions are required around what “Cloud” refers to with Open Clouds, Community Clouds and Private Clouds all available to organisations. Trevor stressed the importance of being aware of the need to control where our data resides, especially if you need to conduct data destruction at any time.

Chris Reid of Integrity Solutions updated the forum on the ISPE special interest groups including mobile apps led by Sion Wyn of Conformity, the result of which is the ISPE GAMP Mobile best practice. This discussion may have been aimed at addressing issues faced by mobile apps designed for the general public more than the corporate world but was still of great interest to ourselves. Our iEQMS Auditor App for the iPad is in general use by a great number of our clients including those who are FDA regulated.

Sion Wyn

John Andrews of Integrity and Heather Wilkinson from GSK hosted an open floor discussion on regulatory intelligence in which the need for electronic signatures, the FDA being able to take pictures on site and audit trail were all raised. We have been developing a complete audit trail solution to live within EQMS for some time and the points raised within this discussion were reassuring to hear from such an audience.

We attended the round table discussion, focussing on how to select a suitable partner organisation when outsourcing key functions, while as a group we exploring how such a critical relationship is measured. It’s hard to give a definite answer for this but a mixture of well-designed metrics and the less quantifiable ‘how well do they deliver this service’ appears to be the best measure.

"It was enlightening to spend the day with Quality professionals from the Pharmaceutical world, sharing ideas and best practice during the round table break-out sessions. As a supplier of an audit manager application currently in place within the pharmaceutical industry, the final presentation on the use of Mobile Apps within the industry was very interesting and has started numerous new product discussions within our organisation."

- Ben Saxton, Qualsys' Business Development Manager

Qualsys value the continous personal development of their staff as well as ensuring EQMS is developed to provide a solution to the challenges faced by both prospective and existing clients alike. The ISPE GAMP forum helped deliver on both of these points. For a more in depth report or to receive a demonstration of the iEQMS Auditor App please contact Ben or Michael on 0114 282 3338

Request Demonstration

Tags: EQMS, Events, FDA, Pharmaceutical Regulation, GAMP

‘Obamacare’ shifts global power balance of Pharmaceutical Industry

Posted by Michael Ord on Fri, Oct 18, 2013

As the gridlock in Washington subsides for the time-being, the effects of the Patient Protection and Affordable Care Act; so-called ‘Obamacare’ are set to extend to all corners of the globe.

washington 


Obamacare looks set to trigger a shift in the balance of power in the global pharmaceutical industry. We review the news to identify the key issues for Quality and Compliance Teams within Pharma-chem companies.

$350b Bonanza for Indian and Chinese Pharma

pharma image

The introduction of the new legislation will inevitably lead American purchasers to source generic drugs at a reduced cost. Indian and Chinese generic manufacturers are gearing up for a bonanza that will see them try to prise away market share in the $350 billion US market.

The major challenge for the Indian and Chinese manufacturers will be compliance with exacting FDA regulations and the introduction of compliant manufacturing processes and record keeping essential to deliver the product quality expected by the American market.

FDA Sanctions in 2013

Already this year, according to agency data, as many as 19 manufacturing facilities in India have been barred by the FDA from supplying products to the US, more than any other country. Problems faced by Ranbaxy Laboratories, Wockhardt, RPG Life Sciences and Dabur India have been widely publicised and here. Chinese Pharmaceutical facilities have received the next highest number of sanctions at seven.

Indian and Chinese companies will need to accept intense scrutiny if they want to make the most of the opportunity. India is one of the first countries, apart from China, in which the FDA has opened offices, and the country recently allowed the regulator to increase its number of inspectors in the country by seven to 19.

Conclusions

The US and European pharmaceutical giants will no doubt look to protect their position but this is likely to lead to cost-cutting and pressure on the ability to deliver quality at the right price.

This dilemma of a squeeze in resources and a demand for greater efficiency will force Quality Managers and Compliance Teams to review their processes, adopt new technological approaches all under the burden of greater over-sight.

Ultimately, the consumer is set to benefit provided the FDA and other regulators retain the power and sanctions needed to assure their protection.

Robert Oakley, Qualsys Director said:

"At Qualsys, we are already seeing a greater demand for iEQMS Auditor for mobile auditing, ECMS Change Management software and EQMS Risk Manager - all tools with powerful workflows that can easily demonstrate business efficiencies and ROI. 
 

iEQMS Auditor for iPad

EQMS interest from Pharmaceutical Manufacturers in China, the Middle East and the US, shows us that everyone sees the same opportunity and feels the same pressures.

It will be interesting to see how Obamacare plays out."


 

Attend Free Webinar


Image credit: here and here

Tags: EQMS, FDA, Pharmaceutical Regulation

Compliance and Document Management Software - Qualsys User Group 2012

Posted by Gemma Baldan on Wed, Nov 14, 2012

Thursday 8th November saw our sixteenth annual user group. Our UK based clients travelled over to Qualsys head office in Sheffield for a day packed with ideas, new developments and sharing of best practice.

EQMS User Group

Rob Oakley, Commercial Director speaking at the EQMS User Group on 8th November.
 

The day kicked off with a look at some of our most recent developments, to some great feedback. The new Dashboard and Training Manager we’re both warmly welcomed, and we received some useful product enhancements ideas to consider for future versions.

After lunch, we took a look at the future of EQMS and some potential user interface designs.

describe the image

“Our user group attracts a range of customers, from those who were responsible for the initial implementation of EQMS across their organisation, to Document Managers, IT Managers, Compliance Managers and general system users. Sharing our vision of EQMS and encouraging comment enables us to capture direct feedback from every type of user, this really does shape how we work”. Michael Ord, Client Support Manager

We looked at the current EQMS interface and reviewed some potential ideas for future versions, all of which were well received. One key point when considering changing the EQMS interface is that current users continue to find it a simple system to work with. 

EQMS User Group 

“The user group is a fundamental part of EQMS’s future development. We share new pre-market products and take suggestions and feedback from our clients; they are at the centre of what we do. We plug the feedback straight back in to the product; everything we do is user driven.” Gemma Baldan, Account Manager

Many of our clients have thousands of users. Moving forward, we review how we can lift and gently change the interface of EQMS to be even more intuitive, whilst keeping the fundamental principles the same.

describe the image

 "The day spent with the Qualsys team and other members of the User Group was by far one of the most enjoyable study days that I've been on. The information was presented clearly. The round the table discussions provided an insite into how other companies utilised EQMS effectively. A thought provoking and enjoyable day - Thank you"

Gillian Southwart, NHS

"The Qualsys team are helpful and friendly whilst still being very professional. It's so refreshing to deal with a company who wants our feedback and is keen to act on it."

Helena Mchutchison, Oxford University Press

"A slick, well organised day. Essential up-to-date technical developments and user discussions delivered in a relaxed and friendly way, as you would expect from the Qualsys team."

Tom Ray, Diageo

"EQMS works for my basic requirements but the The User Group did highlight to me that EQMS is far more adaptable than I thought and we probably to not use it to its max capabilities in our Trust"

Deborah Scott, Leeds Teaching Hospital 

"Only recently been in contact with Qualsys but am pleased with the level of customer care that they provide."

Matthew Pendleton, Nothampton General Hospital

"It would be far to say that EQMS is an essential tool in delivering and evidencing our compliance framework. I look forward to the planned developments which should further embed EQMS as a cornerstone of our systems."

Mark Davy, Quality Manager, Leeds Teaching Hospital 

For more information about Qualsys' support services or User Groups, please speak to us, we'd be happy to hear from you:

Click to contact us

 

Tags: EQMS, Events, FDA

Validated Computerised Quality Systems in GxP Environments

Posted by Gemma Baldan on Fri, Nov 02, 2012

Is the system fit for purpose?

It’s crucial that organisations operating across the Pharmaceutical and Medical Device industry carefully consider the impact of the introduction of computerised quality system applications. 

The European Medicine Agency's (EMEA) Guidelines to Good Manufacturing Practice (GMPs) - Annex 11, Computerized Systems (aka EU Annex 11) and The Food and Drug Administration's (FDA) rule on Electronic Records/Signatures (21 CFR Part 11 aka Part 11) are crucial in the manufacture of pharmaceutical products.

compliance

Businesses operating within the Medical Device and Pharma industries are compelled through the FDA and EMEA to instigate a formal validation process to ensure that all software is fit for purpose.  Whilst the legislation that governs particular sectors may vary, the principles of software validation are consistent and typically demand consideration of the following areas:

  • Software Vendor Development Methodology
  • Customer Requirement
  • Customer System Specification
  • Software Verification
  • System Validation
  • System Change Control and Validation
  • Problem Resolution Process and Tracking

So how can we ensure that a computerised quality system is fit for purpose under either Part 11 or Annex 11?

Whether operating under Annex 11 or Part 11, all computerised systems used in GxP regulated environments require compliance for ensuring integrity of data and records. 

 The FDA suggests that “when computers are used as part of the quality system, the [device] manufacturer shall validate computer software for its intended use according to an established protocol. This has been a regulatory requirement of FDA's medical device Good Manufacturing Practice (GMP) regulations since 1978”

 EMEA Annex 11 goes further into the requirements of computerised systems than Part 11. There are specific points in Annex 11 that relate directly to the supplier and service provider of the software. It addresses formal agreements, software review and supplier audits.  It is important to note that a software supplier cannot sell a validated system; validation requires a risk-based approach that the system performs as intended in its actual environment; however a system can provide the functionality to enable compliance with the specific regulations.

Key considerations:

When evaluating computerised quality systems, consider if the system;

  • Provides access control /user management.
  • Allows only authorised changes to data and documents
  • Ensures data integrity including: prevention of deletion, poor transcriptions and omission. 
  • Provides full time stamped audit trails
  • Provides Disaster recovery / Back up and retrieval
  • Provides the use of Electronic Signatures where necessary
  • Allows for system maintenance and change control
  • Supports management of training documentation

  

Five tips to help ensure you select the right supplier:

  1. Evaluate the quality methodology of the supplier; how do they design, construct, supply and maintain the software? Do they have relevant ISO9001 and TickIT quality marques in place to underpin the way they work?
  2. Understand the history of the vendor’s suppliers, if they have outsourced work – was all the software built in house? If not, how are the vendor’s suppliers quality checked?
  3. Are any third party apps used within the software? How heavy is the vendor’s reliance upon these apps, and how reliable are the apps themselves?
  4. Consider any known limitations of the software package or versions and the adequacy of any corrective actions by the Supplier.
  5. Has the supplier supplied to GxP regulated industries previously? Was the software compliant in ensuring integrity of records and data
Finding a vendor that you can trust to work closely alongside you is crucial to the success of your project; in our next post we'll be discussing key considerations of vendor selection.
For further help or information, feel free to Get in touch. We'd be happy to hear from you.

 

Tags: Quality Management Software, Annex 11, Risk Management, Compliance Management Software, Document Management, FDA