TrakCel is proud to announce that it has added ISPE (International Society for Pharmaceutical Engineering) and BSI (British Standards Institute) to its professional memberships as part of its commitment to operational excellence. The addition of these professional memberships underpins TrakCel’s commitment to latest critical requirements for advanced therapy technology standards.
The International Society for Pharmaceutical Engineering (IPSE) is the world’s largest not-for-profit association serving its Members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. As a member, TrakCel will join more than 18,000 professional peers from more than 90 countries in advancing the solutions that lead to improved patient health.
In addition to the membership of IPSE, TrakCel has also joined The British Standards Institution (BSI). BSI is recognized as the chartered royal society for national and global standards and is a leading authority for the pharmaceutical industry in the UK. BSI supports continuous improvements to business globally and has been providing guidance to companies for over 100 years.
TrakCel’s commitment to operational excellence is reinforced through the addition of these professional memberships and demonstrates the company’s ongoing mission to provide best in class solutions to the cell and gene therapy industry. The addition of both IPSE and BSI to TrakCel’s professional membership portfolio allows the company to become more closely aligned to standards and best practices in the industry, ensuring that TrakCel remains at the forefront of the latest development and changes in the regulatory, quality and IT landscape.
As a result, TrakCel’s global client base will benefit from:
Best in class Security – Aligned to ISO 27001. Globally recognized as the highest information security standard.
ISO 9001 Quality Management Systems – TrakCel’s QMS is aligned to the requirements of ISO9001, the world’s best–known quality management standard, ensuring our clients get consistent, quality product and service from TrakCel.
Business Continuity – Aligning towards ISO 22301, recognized as global standard for ensuring customer and TrakCel’s business continuity.
Software Validation – TrakCel follows the ISPE GAMP 5 framework, ensuring TrakCel products are produced and implemented to this industry recognized approach.
Cyber Essentials – The UK minimum requirement for providing cyber resilience and maintaining the requirements for GDPR. Working our way towards the certification.
Speaking of the professional memberships, Chris Gowing, E-Compliance Lead at TrakCel, states:
“Becoming members of two globally recognized professional bodies will ensure that TrakCel remains at the forefront of quality, technology and security standards. We look forward to actively contributing and continuing to maintain the highest standards as our technology evolves”.
The addition of both IPSE and BSI memberships to TrakCel’s Quality Team is the latest in a series of steps towards continuous improvement. During the COVID-19 pandemic TrakCel has adapted to facilitate interactive remote audits for clients globally. You can read more about how TrakCel’s team has done this here.
About the ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 18,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA and the Operations and Training Center in Tampa, Florida, USA.
BSI enables people and organizations to perform better. We share knowledge, innovation and best practice to make excellence a habit – all over the world, every day. Our purpose is to inspire trust for a more resilient world. Our solutions and services improve performance and support the United Nations Sustainable Development Goals. At BSI, our mission is to share knowledge, innovation and best practice to help people and organizations make excellence a habit. This is underpinned by our role as the national standards body and through our prestigious Royal Charter.
About Cyber Essentials
Cyber Essentials is a simple but effective, Government backed scheme that will help you to protect your organisation, whatever its size, against a whole range of the most common cyber attacks.
ISO, the International Organisation for Standardisation is an international standard-setting body composed of representatives from various national standards organizations. Founded on 23 February 1947, the organization develops and publishes worldwide technical, industrial and commercial standards.
Article by TrakCel Marketing Team - 17 Dec 2020