Testimonials from clients

“Engaging with the team at Maly was a pleasure. They immediately got on board with the concept of the project and helped shape how the project would unfold. Working to our preferred methodology meant they were a valuable partner in delivering our project.”

Carl Farmer – Senior developer at Chrysalis Technology

Our case studies speak for themselves

“From the first day to now this has been an outstanding experience. I could not recommend them highly enough.”

Andrew Rooney – Product Lifecycle System Coordinator at Allergan (Acquired By AbbVie Inc.)

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 medicines that solve serious health issues today and address the medical challenges of tomorrow. With over 47,000 employees around the world, AbbVie focuses on delivering transformational medicines and therapies that offer significant patient benefits. Allergan Aesthetics is part of the AbbVie portfolio, and was Maly’s first client in 2010.

The Challenge

As with all American pharmaceutical enterprises, AbbVie is subject to the Good Manufacturing/Distribution/Laboratory Practice of GxP, where x denotes the specialist field. Quality assurance is essential and all software is stringently verified ahead of going into production. Allergan approached Maly in 2010 and while the initial challenge was looking at sales operations, taking data from multiple sources and producing reports to support the frontline sales teams, it became apparent that the systems in place across the business could be significantly improved by taking a more holistic view of the regulatory and process requirements. Maly were asked to look at all the business processes, map the different systems and establish clear objectives for each. Rules and steps for each process were required so responsibilities could be assigned and progress tracked. Specifically, one of the initial challenges was a disconnect between the Regulatory Authority(RA) department and the Artworks department. Between the two they were responsible for the highly complex and regulated labelling process, with Artworks responsible for the design of the labelling, packaging and messaging to support each product and RA responsible for the adherence to the strict regulations and laws as dictated by each country’s Ministry of Health. By not using a common process or supporting system, the two departments were not working together effectively, leading to significant risks of incorrect labels or packaging. If errors of this kind made it to the shop shelf, there was the risk of harm to consumers, potential stock recalls, brand damage and fines.

The Solution

Having worked with Allergan and then AbbVie for over 10 years, Maly was best placed to understand the complexity of the processes involved and be able to design new software and enhance existing software to ensure appropriate security, availability, accessibility and integration, as well as compliance with the regulatory constraints placed upon the business. The initial solution was to design an Artworks Project Management system, including an electronic form for the RA department to complete, progress could be shared automatically, streamlining the process and putting in place the rigorous standards of data and system security required. With so much of the artwork itself outsourced to a third party, the internal project management capability of the new system ensured the Artworks Department could accurately track and flag nearing deadlines and milestones, manage timelines and record performance metrics. 

The Artworks Project Management System was the first solution in a series of innovative software tools designed and deployed by Maly. Subsequent systems included a Score Carding system for the Quality team, where Maly integrated data from multiple systems to provide team performance scores against quality targets; a Workflow Management System that can be used for a variety of processes, prompting action at appropriate times; and a Temperature Excursion tracking system for the transportation of temperature sensitive drugs. 

Collectively these systems became known as The Hub, a flexible, highly configurable, centrally managed set of process management tools with intuitive dashboards, making them easy to use. Maly’s flexible, innovative solutions have streamlined a number of manual, fragmented and iterative processes, saving AbbVie both time and money.

The Results

Maly understood the level of process control required for a global pharmaceutical enterprise. They developed and deployed a number of fully integrated systems that solve many different process control and project management scenarios that vary from a shared electronic form between highly regulated departments, to vital temperature tracking software, ensuring the integrity of temperature sensitive drugs. 

AbbVie now has a process control Hub that is designed for the way they work and is accessible, flexible and cost effective.

From a quality perspective, The Hub means that during internal and external audits there is less exposure to non-conformity, and when issues do occur AbbVie can respond quickly, putting corrective measures in place.  This efficient, seamless, highly configurable and resilient solution has revolutionised process control within AbbVie.

Business Benefits
  • Flexible, configurable system that can be used in many process control scenarios
  • Increased visibility and control over all processes
  • Reduced exposure to non-conformity
  • Exception management, they can respond quickly and put changes in place to resolve 
  • More efficient communication between siloed departments
  • Seamless integration with existing systems  
  • Improved performance reporting and management
  • Better business insight with easier access to business data

“Maly are a great team to work with, they know what they are doing and we trust them with the development and maintenance of our software tool.”

Lesley Kumar & Palvinder Gil, Partners & Co-Founders, Insight Regulatory

Outstanding support for regulatory compliance product

About Insight Regulatory & Cerberus

Insight Regulatory LLP was set up in 2018 to provide large companies in the financial services and banking sector with practical, pragmatic and effective compliance, risk and prudential regulatory advice. This is based on over 50 years of the combined experience as regulators and in-house experts of the founding partners Lesley Kumar and Palvinder Gil gained at organisations including Bank of America and the Financial Service Authority (FSA). They are particularly focused on helping clients put in place the right governance, processes ad reporting to ensure they remain compliant at all times with stringent UK and global regulations and rules regarding financial transactions and trading. As a result they have created their Cerberus Platform which is designed to help financial institutions remain fully compliant with the Senior Managers and Certification Regime (SMCR) rules. The platform provides:

  • Real time compliance activity monitoring
  • Detailed compliance reporting for user with audits and regulators
  • Simplification and control of staff certification
  • Responsibility and governance mapping and tracking

All this is delivered through a simple and intuitive UI tailored to the specific internal structures and processes used by financial services companies.

The Challenge

Having created an initial MVP of the Cerberus Platform using overseas development resource Insight were now looking for a UK partner who could deploy, operate, support and further develop the solution in response to customer requirements. This would need to be done in a highly secure way given the sensitive nature of the data being generated on the platform as well as being robust and scalable to support any users across multiple financial services clients. Insight were also looking to further enhance the platform with a process modelling and automation capability so that it could help clients track many instances of complex compliance processes such as transaction reporting. Insight were introduced to Maly who’s Okuda tool had the potential to address the complex compliance process requirement, however the Maly team also had the skills and proven track record to be able to deploy and operate a platform of this type for major corporate clients.

The Solution

Maly we’re able to get to grips with the Cerberus MVP, understand its design and code base and architect a solution to host it securely on AWS. Having deployed it they then put in place the operational and support services required to make it robust and reliable solution to demonstrate to potential clients of Insight. Maly also developed a parallele “Sandpit” version of the Cerberus Platform which they used to develop and test  range of new features and capabilities for insight such as additional audit reporting, improved email certification and improved notifications of overdue compliance steps.

The Result

Insight now had a robust and reliable first version of their Cerberus product that they could demonstrate to their financial service customers as well as an expert technical team in place to be able to support any proof of concepts or implementations that they secured as a result of their business development activities. Furthermore they had had a product development roadmap (with supporting testbed environment) Cerberus including planned multi-tenancy so it can support multiple corporate clients (and many concurrent users) simultaneously and future integration with Maly’s Okuda tool to bring low code process modelling and automation.

Customer Feedback

 “We’re very happy with what Maly have done for us and have a great working relationship. Maly work at our pace and have the technical know-how that we needed to upgrade our software product. They have great experience and are very responsive to our needs and have taken the time to understand our product and improve it. We have access to all the experience in the team and are great to deal with on a personal level. We trust Maly to do what we need and provide advice on the best way forward.”

Lesley Kumar & Palviner Gil, Partners & Co-Founders, Insight Regulatory

Whether we are building a platform for a FTSE 100's supply chain regulation or helping a start-up to punch above their weight, we take immense pride in the level of impact we have had on the businesses we have worked with.
Please see a few examples of this work below.