Category Epic Management Team

EPIC Auditors Awarded Cyber Essentials Certification

Cyber Essentials Accreditation

Cyber Essentials Accreditation

This month, Epic Auditors are proud to announce that they have achieved certification from Cyber Essentials proving their dedication to guard against cyber threats and demonstrate a commitment to cyber security.

What is Cyber Essentials?

Cyber Essentials is an official UK, Government backed scheme that encourages organisations, of all sizes to adopt best practice in information security and ensures they take sufficient measures to prevent against the risks of possible threats against a whole range of cyber attacks.

The Cyber Essentials Certification is awarded by means of an independent assessment of the business security controls and processes, it also gives peace of mind that company defences will protect against the vast majority of common cyber-attacks. Receiving this accreditation shows that EPiC Auditors have addressed those basics to prevent the most common attacks within their systems.

Richard Andrews, Managing Director of EPiC Auditors commented “Achieving the Cyber Essentials certification is crucial in ensuring our cyber security is as strong as possible to protect our clients’ sensitive data. Our clients can have the confidence and trust that we are following best practice guidelines and recognise the importance of keeping their information safe and our IT systems secure.”

EPIC Auditors are dedicated to investing in its cyber security and will continue to adopt best practices in their information security strategy to ensure that the data we hold is managed properly and kept in a secure and safe digital environment.

The Pharma Tech Outlook’s QA Awards 2022

EPiC Auditors Awarded Top 5 Quality Assurance Services Companies in the UK

We are delighted to announce that EPiC Auditors have won a place in Pharma Tech Outlook’s Top 5 Quality Assurance Services Companies in the UK 2022, the annual listing of 5 companies in the UK that are at the forefront of providing Quality Assurance services and transforming businesses in the region.

Pharma tech Outlook publication

Specialising in performing mock inspections, GXP audits, supply chain and system audits, delivering bespoke training and supporting post-inspection remediation EPiC Auditors help clients achieve and maintain regulatory compliance.

Comprising of an experienced group of ex-MHRA Inspectors, the EPiC management team and consultants fully understand clients’ diverse needs and can therefore advise the best course of action to address the challenges they face and make their operations compliant with MHRA and EU regulations and guidelines by providing comprehensive GXP consultancy service.

As ex MHRA inspectors, EPiC Auditors is able to bridge the gap between pharmaceutical companies and the regulatory bodies, making us ideally placed to provide the knowledge, skills and expertise to drive sustainable compliance across the UK and Europe’s pharmaceutical and biotechnology industries.

You can access the Pharma Tech Outlook Magazine Quality Assurance Edition and read the full feature article here: https://www.pharmatechoutlook.com/magazines/May2022/Quality_Assurance_Europe/?digitalmagazine

MHRA Compliance Monitor Process (Part 2)

MHRA Inspectorate Blog has recently published Part 2 in the Compliance Monitor Process series with further information about the Compliance Monitor (CM) role and application process.

The blog can be found here: Compliance Monitor Process (Part 2)– CM role and application process

The blog acknowledges that it is common for companies that are at IAG to employ consultants to assist with remediation activities, and this is something that EPiC has extensive experience of supporting including reporting on progress to MHRA. The application process for an individual to apply for the CM pilot programme to be named on a register will be based on an eligibility assessment by MHRA considering career history, relevant experience, not having been personally the subject of MHRA regulatory action and/or significant adverse findings in the previous 3 years, and the need to have completed relevant training in the CM process. Eligible CM’s will then be assessed by MHRA for suitability on a case-by-case basis when they are nominated by a company, to confirm that they have sufficient experience of the dosage forms and site operations and that there is no conflict of interest. 

In response to the recent MHRA Inspectorate Blog post, Richard Andrews commented “It is good to see that both eligibility and suitability of the CM are being assessed which draws parallels from the naming of Qualified Persons (QPs) on UK manufacturing licences. Although a QPs eligibility to be named may be assessed by the Joint Professional Bodies, MHRA, or an EU regulator, their suitability to be named on a specific UK manufacturing licence is assessed and decided by MHRA based on site-specific knowledge and experience, which is above and beyond their eligibility assessment. The same two-stage approach will help to ensure CMs will have the background experience and site-specific knowledge to assess risks to product quality and patients in developing and overseeing remediation plans and assisting with implementation. This type of remediation work is a core service we offer at EPiC and is why our consultants will be applying to be named as CMs.”  

Compliance monitoring

MHRA Compliance Monitor Process (Part 1)

At EPiC, post-inspection remediation is a core element of our GXP compliance consultancy service. Many of EPiCs consultants have experience of MHRA Compliance Management team (CMT) and Inspection Action Group (IAG) processes, gained working within the MHRA and also outside as consultants. EPiC auditors regularly support companies who have been referred to CMT or IAG , leading root cause analysis workshops, advising on the response to the inspection findings, developing remediation plans and assisting with implementation. In a number of cases, EPiC have also provided assessment of compliance improvement following MIA suspension which have led to reinspection by MHRA and lifting of the suspension.

In response to the recent MHRA Inspectorate Blog post, which can be found here: Compliance Monitor process (Part 1) – An introduction

Richard Andrews commented ‘Based on our extensive experience to date, EPiC fully supports MHRA’s plan to further evolve it’s risk-based inspection practices with the launch of the compliance monitor process, which will see the MHRA begin a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors. EPiC intend to apply to be named on the register of MHRA compliance monitors and eagerly awaits the publication of the second part of MHRA’s compliance monitor process blog, which is expected to provide more details on the Compliance Monitor role and application process’.

Richard Andrews
Richard Andrews-EPiC Managing Director and Senior Consultant

MICHELLE YEOMANS TO JOIN EPIC AUDITORS IN APRIL

Another ex MHRA Inspector Joins the EPiC Team

EPIC Auditors is very pleased to announce that Michelle Yeomans will be joining us on 7th April to fulfil the role of EPIC Auditors Operations Manager. 

Michelle Yeomans

EPIC Auditors was established in 2014 by Liz Allanson and Darren Jones (both ex MHRA) to fulfil the increasing need for ex MHRA Inspectors to conduct mock regulatory inspections and to provide consultancy advice from the Regulatory perspective. The company has developed considerably over the last 8 years and Michelle has been appointed to further strengthen the management team and assist with the day to day operation of the business.

Michelle is well known to the pharmaceutical industry having been in the MHRA GMP/GDP management team for many years and been a familiar face at many MHRA GMP/GDP and GCP Symposia.  Michelle has completed 17 years in the MHRA starting as a GCP Inspector, progressing to Senior Inspector and gaining accreditation for GMP inspections of manufacturers of clinical trials, before moving to become a GMDP Operations Manager and ultimately the GMDP Inspectorate Unit Manager.

Michelle brings to EPiC not only the considerable length of service in the MHRA, at both Senior Inspector and senior management level, but also excellent organisational skills, and 19 years previous experience working and auditing in the pharmaceutical industry.  Michelle held positions in Technical and QA roles with various pharmaceutical companies and operated as an IMP Transitional QP prior to joining the MHRA.

Over the years Michelle has engaged extensively with the industry and we are sure this will continue as she works with our clients to help them to improve their GXP quality systems and regulatory compliance.

We are really excited about Michelle joining our team, and acknowledge the skills that she will bring to improving our own quality systems as well as those of our clients.

You can read more about Michelle’s background and qualifications as well as meet the rest of the EPiC Auditors Team here: Meet The Team

If you need our help and support then please don’t hesitate to contact us.

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