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Re-thinking the compliance management process

By Puni Rajah

Compliance management may not be the most scintillating subject in the world, but it is vital to meet regulatory requirements. Many life sciences players find it challenging to achieve the required record quality within regulatory deadlines. But what if the number of deviations closed on time can be improved from 34% to 94% while reducing the time required closing deviations from 66 days to 29 days? We talked to Raymond McKinney (RM) who delivered precisely these results through NNIT’s Compliance-as-a-Service initiative.

Q: Let’s start at the beginning – what exactly is Compliance-as-a-Service?

RM: Life science companies are required by regulatory authorities (e.g. FDA) to investigate deviations from regulation and procedure and, when necessary, initiate Corrective And Preventive Action (CAPA) to prevent these problems occurring in future. Additionally, changes to systems that can affect drug quality must be documented and approved to ensure that the validated state is preserved. However, many staff at pharmaceutical companies do not have enough experience of authoring these records to prepare them to the required standard or within the required time limits. Records are therefore
often incomplete, difficult to understand, or overdue. Compliance-as-a-Service (CaaS) gives our clients access to a team at NNIT which provides technical expertise on the authoring and closing of deviations, CAPAs, and change management records. This improves customers’ inspection readiness.

Q: Compliance has traditionally been fiercely guarded as a necessary total in-house capability. Why are clients re-thinking their approach?

RM: Pharmaceutical and medical device companies have been reluctant to work with external partners in the area of quality management out of a concern that there will be a misalignment in their priorities and those of the contractor organizations. However, we have worked closely with clients to develop an innovative management process that delivers real-time visibility through a KPI dashboard that provides clients with assurance of quality performance. Tying these metrics to our commercial agreement ensures alignment of priorities. Pharmaceutical companies are also finding that they are coming under increasing regulatory scrutiny. Requirements are getting tighter, and many already struggle to close deviations, CAPAs, and change management records on time. During inspections, badly written and numerous overdue quality records have translated into serious compliance risk. Inadequate and delinquent quality records set the tone for how well a company is complying with regulations. Therefore, companies have to rethink their approach and look for an alternative to having the time-consuming and expensive capability in-house.

Q: How have you built the capability that requires so many complex skills?

RM: Our first priority was to assemble a quality records team that has the compliance expertise and experience of pharmaceutical and medical devices processes across the research, development, manufacturing, marketing, distribution and after sales field operations. In addition to looking for technically capable people, we require our team members to have outstanding interviewing, writing and communications skills. Finding such a combination of capabilities requires a commitment to constantly screen for candidates. Because NNIT has a large business focused on progressive life sciences practices, we are able to hire and retain these multi-skilled people. We are able to scale our involvement with client requirements and whether supporting a single department or managing quality records for a global multi-national,
we can provide a blend of on-site teams or staff located in our offices around the world.

Q: The term ‘as-a-service’ implies cost will match results. How exactly are you defining this relationship?

RM: We see the metrics as the most practical point of focus to clarify the match between cost and results. To ensure regulatory and client procedural requirements for timeliness and record quality, NNIT tracks each step of the development and approval process.
By establishing visibility on the expected service levels and measuring performance, we are able to drive improvement. Linking our remuneration to these measures has resulted in quantifiable improvements in results across all record types. Our clients get on-time records closure, effective records that improve quality, and minimal management resources from their side. If the clients were to establish this service internally, they would need management resources redirected to recruitment, training, monitoring, performance measurement, and day-to-day management of personnel. NNIT’s Compliance-as-a-Service lifts this entire burden. This process has just helped one of NNIT’s clients improve the number of deviations closed on time from 34% to 94% while reducing the time required to close deviations from 66 days to 29 days.

Q: What’s next for your compliance-as-a-service initiative?

RM: We are thrilled to have started this journey by winning over client trust such that we have staffed their in-house quality records teams and managed to improve the number of deviations closed on time. We have demonstrated that with the right level of transparency built into the process, clients can still maintain necessary oversight. Currently, we are developing the infrastructure to allow companies of all sizes to engage with us. Our focus is on driving major improvements in compliance metrics at a reduced total cost for the whole industry, from the largest multinational to the smallest start-up.​



 

 

 

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