CASE STUDY

Oxford Biomedica adopts Pisys Permit to work

Summary

Oxford Biomedica (‘OXB’), the UK-based contract development and manufacturing organisation for cell and gene therapies, has deployed the Pisys Permit to Work system across five sites, replacing a paper-based process that offered no cross-site visibility and no reliable link between permits and isolations. Following a rigorous IT security review, a three-month trial and a six-month configuration programme, the system is now central to how OXB manages contractor activity and risk assessment across its operations.

Background

OXB is a leading CDMO specialising in viral vector manufacturing for cell and gene therapy, with operations across five UK sites. Listed on the London Stock Exchange, OXB works with global pharmaceutical and biotech partners at various stages of development and commercial manufacture. The scale and regulatory complexity of its operations place high demands on its control of work processes.

Challenge

Before adopting Pisys, OXB managed permits to work using paper across all five sites. Jovan Lazarof, Director of Engineering  summarised the main issues:  ‘The core problem was visibility – there was no way to see, from a central point, which permits were open across the estate, where isolations stood or which permits were overdue for handback.

Linking isolations to permits was a particular gap. Under the paper system, there was no reliable mechanism to show which isolation was attached to which permit, or to track the open and closed status of both together. Reporting on outstanding permits required manual checking rather than any kind of live dashboard.’

Solution

As a regulated biopharmaceutical manufacturer, OXB applies rigorous standards to any third-party system touching its operations. Before Pisys could be onboarded, the company’s procurement, legal and IT security teams all had to be satisfied – a process that involved formal supplier engagement, purchase order approval and a detailed security review covering server location, data handling credentials and backup arrangements.

The IT security stage was the most intensive part of the onboarding process. OXB’s IT team required documented evidence of Pisys’s security posture before granting any access, and there were several rounds of clarification and response before the criteria were met. Single sign-on was then implemented through direct collaboration between Pisys and OXB’s IT security function – a further technical step that needed to be resolved before the system could go live for end users.

Pisys worked through each of these requirements systematically. Jovan noted that the speed and openness with which information was provided was a significant factor in getting through the process without it stalling.

An initial two-week trial was extended to three months at OXB’s request before the organisation committed to an annual subscription. During that period, all permit types were configured within the system. Jovan then worked with the Pisys support team, refining workflows, adjusting permit structures and building access groups for different user types.

A significant change was the migration of risk assessments from OXB’s previous system into the Pisys platform. This allowed risk assessments to be linked directly to permits, and – crucially – a single risk assessment to be attached to multiple permits, removing duplication that had existed under the old approach.

Result

The most significant operational improvement has been cross-site visibility. OXB can now see the status of all permits across all five sites in real time, including which are open, which isolations are active and which permits are outstanding for handback – information that simply was not available under the paper system.

User adoption has been straightforward. Jovan noted that the system requires no specialist training for staff who are comfortable using a PC: the interface is structured clearly enough that most users can navigate it without formal instruction. Custom access groups control what each user type can see and do, with restrictions that prevent users from taking actions outside their role.

The next phase is mobile rollout, with the end goal of having contractors request permits before arriving on site, with documentation pre-attached and ready to issue on arrival. A risk assessment statistics dashboard – equivalent to the permit statistics screen already in use – is also in development.

IMPROVED

Visibility

SIMPLE

Operation

BETTER

Risk Management

Testimonial

The system is very easy to use and very user friendly.  The support team is always available, responds quickly and is very knowledgeable. Well done to Pisys for getting us to where we want to be. If you know how to use a PC and how to fill in a form, you don't need training - you just follow the instructions.

Jovan Lazarov, Director of Engineering, OXB

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