Credit: International Institute for Management Development (IMD) This February, I have decided to return to the topic of future readiness of pharmaceutical companies. It is a topic which has been gnawing away at me for well over a year, even before I first wrote about it (see Pulse 19 March 2024). Future readiness – a […]
ProblemAn organisation working towards gaining ISO 9001 Quality Management System certification was experiencing significant challenges. They needed to establish processes to follow within the business, but also needed to track compliance with these processes and manage non-conformances effectively. They also needed the scope to integrate the HR needs of the company and asked for a
ProblemLike many of the clients we work with, this particular organisation was using Microsoft Word and Excel to record and share data as part of one of their key processes. Typical challenges were resulting in a process that was inefficient and did not meet the requirements of the regulators: forms getting lost; poor version control
ProblemAn established software house was having problems with performance on a particular piece of software. It was believed that the issues systemic and so they commissioned us to work with them in finding a solution. SolutionWe placed one of our most senior developers with over 30 years experience on site who performed a comprehensive analysis,
ProblemTwo separate departments collaborating on the same regulatory affairs process were suffering from a lack of evidence, accountability and transparency which was resulting in poor communication and non-conformance notices being raised against them both. SolutionWe built a new cloud-based system to manage the process for both departments. By coming in as a neutral 3rd party
ProblemThe labelling and artworks department of this major multinational pharmaceutical company was having challenges in streamlining the process workflow. Projects were incorrectly prioritised, bottlenecks were created by other teams and operational output was below requirement. SolutionAs the system involved interaction with many regulators for multiple projects it was critical that our analysis and solution were
No matter what your business provides, every company has a set of regulations that they must comply to, something that amongst the bustle of a heavy workload, can get lost. Resulting in a non-compliance, without the knowledge that it is occurring. What we want to outline for you today is 5 of the main compliance
Maly deliver Innovative Process Control via The Hub About AbbVie Inc. Based in the US, and founded in 2013, AbbVie is a biopharmaceutical company. It brings together the stability, global scale, resources and commercial capabilities of a pharmaceutical company with the focus and culture of a biotech. AbbVie’s mission is to discover and deliver innovative
We once again are happy to have new team members joining us! First we are excited to introduce another developer, Kieran, to the growing Maly team. Kieran is an experienced software developer and programmer that we warmly welcome to the team. With his adaptability, solid skillset and his friendly demeanour we are sure he will
We are very excited to have expanded the team again! We extend a warm welcome to Grace and are very pleased to have her as part of the Maly team! Grace will be taking part in our testing processes, undertaking research, and taking on some administration tasks. She is working with us on a part
