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Case Studies

Quality & Regulatory Case Studies

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EU Medical Device Regulation (EU MDR) Compliance

Goals and Business Driver:

Our client needed to achieve compliance with the applicable sections of the EU MDR by 26 May 2020, in order to be able to continue to market medicinal products with delivery devices in the EU, distribute in the EU medical device from other suppliers or to bring new such products to the market. 

Discovery & Design

Enterey consultants were brought in to support the remediation of compliance gaps, previously identified by the Client, through integration and management of 12 cross-functional workstreams.

Implementation

Our consultant managed the project budget and provided key project management support, by leading the day-to-day operations of 12 different cross-functional workstreams, tracking their individual progress against the overall project timeline and defining a communication plan to facilitate the communication between stakeholders group.  Enterey built metrics tracking tools to assess project performance and reported regularly on project status to stakeholders, through email, newsletters and presentations. Our consultant constantly maintained a high level of engagement with stakeholders, by facilitating multi-day workshops and leading regular team meetings.

Results Achieved

Our Client, with the guidance of Enterey consultants, identified the strategy to follow to ensure compliance gap remediation by May 2020. One of the workstreams assessed the company’s portfolio and identified which products and processes needed to achieve compliance, and therefore should have been part of the project scope. Another workstream successfully selected a Notified Body after completion of a selection process that required screening and evaluating several alternative options.

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Product Quality Review Optimization

Goals and Business Driver:

Our client was experiencing increased complexity with product quality review processes in order to ensure compliance with global health authority regulations and an increasingly complex supply chain.

Discovery & Design

Enterey was brought on to define and implement a process optimization program.

Implementation

Working with key stakeholders, we identified breakthrough solutions to simplify data analysis and design a long-term plan to deliver an integrated process for review at both the site and product level. The group evaluated regulations, guidance documents, and inspection trends alongside the product portfolio to create a risk-based and segmented approach that ensures compliance at minimal impact to business operations. The team also developed a streamlined report to minimize resource impact for immediate deployment while longer-term integration and automation activities are being developed

Results Achieved

The updated process and streamlined report closed compliance gaps and decreased quality right-first-time errors as much as 70%, in addition to removing non-value added work and decreasing hands-on-time by >30% per report.

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Product Quality Review Knowledge Transfer

Goals and Business Driver:

Successfully transfer oversight and operation of the Product Quality Review (PQR) process to new global quality site in Canada.

Discovery & Design

Enterey was brought on-board to assist with this PQR transfer by designing a system to facilitate the transfer and develop new training programs to increase efficiency.

Implementation

A team of Enterey consultants designed a knowledge transfer strategy and program to support process transfer. They proactively identified key risks related to loss of information and key resources to prevent the impact to business continuity, and provided oversight for execution of the knowledge transfer activities to onboard the new team members remotely. A train-the-trainer intensive was developed to quickly integrate key members into the global community and ensure integrity of cross-functional process handoffs.

Results Achieved

As part of the knowledge transfer program, the global PQR processes and activities were successfully transferred to the new site while continuing to deliver to business and regulatory delivery timelines. The overall time to train and qualify new authors was reduced from 6-9 months to an average of 4 months while reducing first draft error rate by 25%. The on-the-job training process was further improved to support distance learning activities and maintain data integrity.

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Risk Management Improvement

Goals and Business Driver:

Following an assessment of their risk management processes, our client evaluated these to be inadequate, due to risks not being addressed within reasonable timeframes. The significant backlog of unresolved risks was the result of unclear processes and lack of consistency in identifying and implementing solutions.

Discovery & Design

Enterey was brought in to identify faults in this risk assessment and management process, with the goal of redesigning parts of the process to ensure efficiency.

Implementation

Enterey consultants performed Voice of Customer assessments and facilitated workshops aimed at redesigning the process with clear actions and sustainable triggers. Our team provided templates and tools to standardize risk scoring and prioritization as well as to plan resource requirements by applying the lean concept of capping Work in Progress. To facilitate the implementation of the process, our team also created tools to increase visibility and revolutionize tracking of risk performance indicators. 

Results Achieved

Our client experienced an unprecedented improvement in process performance consistency and communication, with over 50% of the open risk backlog being closed within six months of implementation. This project received formal recognition by the client for process improvement success.

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PAI and Successful Filing

Goals and Business Driver:

Our client set out with the goal of acquiring a commercial product license for its oligonucleotide manufacturing facility. They instituted a pre-approval inspection (PAI) readiness program and obtained EU product approval after a successful audit by EMA. In order to ensure the same success for their upcoming FDA inspection and to ensure no critical observations were reported, our client brought Enterey consultants onboard to conduct a Pre-approval inspection (PAI)

Discovery & Design

Enterey was brought on-board to ensure and support a smooth PAI.

Implementation

Our team supported the PAI and inspection process through internal audits and mock inspections performed by former FDA inspectors. Enterey consultants managed a gap assessment, performed a risk analysis and partnered with the client to prioritize and address the logistics of tackling each item. Our team ensured successful remediation of risks, while maintaining adherence to the applicable regulations and guidelines. Enterey consultants also designed and ran an inspection “war room” equipped with a custom software program and communication process providing the necessary support and documentation to alleviate auditors’ requests and/or concerns during the inspection.

Results Achieved

Our client, with the support of the Enterey team, quickly and satisfactorily resolved FDA auditor’s concerns, therefore achieving a successful inspection with no critical findings. Furthermore, our client achieved their goal of receiving approval for commercial manufacture from both the EMA and FDA.

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Clinical Supply Release Optimization

Goals and Business Driver:

Our client was experiencing increased complexity associated with releasing clinical batches to global locations and ensuring that released batches were fully compliant with all regulatory commitments. Enterey consultants were brought in to support the client in leveraging Annex 16 requirements to streamline their clinical batch review processes.

Discovery & Design

Enterey was brought on-board to ensure compliance with batch releases and to support review processes by creating an implementation plan that slashed inefficiency. 

Implementation

Our team developed detailed solution recommendations and a workable implementation plan. By collaborating with Project Management, Supply Chain, Quality and Regulatory functions, our team mapped the future state business process solutions. Enterey consultants also worked with multiple IT departments to define a technology strategy that would enable these new processes for long term sustainment.

Results Achieved

Our team identified all regulatory gaps, proposed solutions and gain alignment from the organization. All root causes were successfully identified and mapped through a series of in-depth workshops facilitated by Enterey consultants, and solutions were designed to be manageable for the teams to implement and execute. The final set of solutions was designed to ensure that our client could achieve  100% Quality and Regulatory compliance, while removing non-value added work, increasing visibility to clinical supply and decreasing average batch release lead time. 

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Regulatory Complexity Reduction

Goals and Business Driver:

A benchmarking study performed by our client showed that their volume of regulatory submissions was ~50% greater than industry average, driving an onerous and complex workload. This highlighted the need to develop a strategy to plan and manage regulatory technical changes and to reduce overall change volume.  The client set a first-year goal of 20% volume reduction.

Discovery & Design

Enterey was brought in to reach this volume reduction goal, provide a project plan, and execute on said plan to reduce efficiencies.

Implementation

They engaged with key stakeholders to develop and integrated project plan to set milestones and to identify interdependencies, while actively coordinating day-to-day activities for a multitude of related workstreams.

Results Achieved

The team collaborated on designing a future state process including standardized documentation, evaluation and prioritization of the changes driving regulatory submissions, as well as associated requirements for supporting IT solution.  These components drove a 20% reduction in the number of regulatory-impacting technical changes. To further address the workload challenges, the process enhancements also reduced the time needed to assess technical changes by over 50%.

Operations Case Studies

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ERP Implementation

Goals and Business Driver:

Our client was looking to implement a new Enterprise Resource Planning (ERP) system. Support was needed to transition from the existing system to the new software, including coordination with ancillary systems like LIMS and MES. This transition needed to occur during the regular manufacturing cycle to support patients, and the timeline was driven to align with first filing and anticipated PLI for product commercialization.

Discovery & Design

Enterey was brought in to implement an ERP system while ensuring the manufacturing cycle continues on regular schedule.

Implementation

A team of Enterey consultants:

  • Worked with a cross-functional leadership team to design implementation strategies to manage the overall activities needed to support the manufacturing site activities during the cutover, including transition of material being processed, transfer and validation of master data, relabeling of inventoried materials, and revision to controlled documents.
  • Designed and facilitated a process for SMEs to assess over 700 documents for impact from the project, prioritize the revisions required, and drive approval of all documents
  • Oversaw the team of technical writers to create and revise 70 GMP documents for Go-Live with an additional 300 document revision and obsoletions post Go-Live.
Results Achieved

With Enterey’s support, our client achieved system cutover and go-live on schedule, with continuous cGMP manufacturing operations. All required controlled documents were revised and trained on schedule, ensuring personnel was qualified on the new processes and were able to continue make, test, release activities for critical patient delivery.

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Technician Training Program

Goals and Business Driver:

Newly hired Drug Substance technicians required 6-9 months of training before contributing to manufacturing operations, therefore affecting the plant’s ability to be agile in response to changes in demand. Our client was experiencing a sharp demand increase, and needed a significant reduction in time-to-proficiency in order to be able to meet the required increase in output.

Discovery & Design

Enterey was brought on-board to help streamline the training process in order to meet surging demand.

Implementation

Enterey consultants managed the solution from design through implementation, by partnering with manufacturing subject matter experts to design a curriculum roadmap from hire to advanced mastery. This solution moved the client away from an unstructured program of shadowing and SOP reading,  and built a sustainable training support structure that included metrics, documents, qualified trainers and clearly defined roles and responsibilities.

Results Achieved

The process resulting from this effort outperformed the goal of a 90-day timeline from hire to proficiency.  Under the updated training, new technicians demonstrated proficiency in 13 key areas within 30 days of hire, therefore enabling the client to meet nearly double the production demand from the previous year in that plant. As a result of the reduction in the trainee time-to-proficiency, the cost reduction was estimated to be $4M in the first year.

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Facility Maintenance Shutdown

Goals and Business Driver:

Our client required leadership and strategic planning for their semi-annual maintenance shutdown. Until the time they brought in Enterey consultants, their shutdowns involved several different groups, but lacked a central project leader who could oversee the shutdown, while bringing stakeholders together to ensure a safe, on-time completion of routine maintenance tasks supporting projects. This gap in the organization exposed our Client to possible future FDA compliance issues.

Discovery & Design

Enterey was brought in to smooth this process, identify key stakeholders, and develop a shutdown plan that would ensure efficiency. 

Implementation

Our team created project plans that involved different stakeholders from several divisions including Manufacturing, Facilities, Safety and Quality. Enterey consultants collaborated with the client to develop a shutdown project schedule and implemented a process to collect and track maintenance activities during the shutdown. To promote clear communication among the stakeholders and ensure smooth flowing project logistics, daily meetings were held and documented.

Results Achieved

This effort resulted in a timely and safe performance of all maintenance task, along with an improved collaboration and communication process between stakeholders for future shutdowns. A fully-optimized Standard Operating Procedure was developed for the Client to utilize and refer to for future maintenance shutdowns at the facility.

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Scheduling Optimization

Goals and Business Driver:

Our client requested the development of a tool to easily measure manpower requirements in order to enable cost reduction. The requirement for the tool was to be sufficient in optimizing the scheduling for their unique production environment.

Discovery & Design

Enterey was brought on-board to identify and integrate a new scheduling scheme.

Implementation

Enterey consultants successfully developed a high quality, custom, sustainable scheduling tool, which met the client’s need to support the future growth. Following the creation of this solution, our team supported the implementation process, by managing and training the department staff in its use.

Results Achieved

The new scheduling scheme allowed our client to increase labor utilization scheduling by 90%. Moreover, the system reduced scheduled overtime by 85%, while doubling its scheduling capacity. This effort created a business case for moving to the new schedule upon its review by the new Senior Vice President.

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Class A Certification

Goals and Business Driver:

Our client expanded their existing business improvement program to attain Class A certification, as a demonstration of standards in business excellence. The program aimed at ensuring planned and predictable performance and included three key projects: Class A certification, SAP implementation and a Lean Initiative.

Discovery & Design

Enterey was brought on to ensure the attainment of this Class A certification and the completion of all project goals.

Implementation

Enterey consultants, in collaboration with corporate sponsors, developed a detailed plan defining project goals, associated task and a timeline of activities and milestones. Our team held project stakeholders accountable to assess readiness and meet project objectives. Enterey consultants facilitated the formation of project teams with defined goals, standard methodologies and reporting requirements.

Results Achieved

Our client met all project milestones, including Class B attainment by Oliver Wight, followed by Class A certification. Process improvement also resulted in significant labor and raw material savings, including material preparation and site-wide metric reporting.

Strategic Realization

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Clinical Capacity Expansion

Goals and Business Driver:

Our client acquired a clinical plant to meet three key business drivers:

  • Enable the “go fast” methodology for process development and reduce the average timeline from 22 months to under 12 months.
  • Expand clinical capacity so no project waited more than 2 months for a production slot.
  • Allow the expansion of company pipeline for new molecular entities.
Discovery & Design

Enterey was brought on to help meet these three key business drivers.

Implementation

Enterey consultants worked closely with corporate sponsors to define the overall project goals in alignment with the corporate goals, which included reduced project budget, timeline and start up team. Our team drove achievement of project objectives, by managing a multi-dimensional start up team and defined the timing of first production run.

Results Achieved

This effort enabled the client to meet all project milestones, budget and workforce constraints. The acquired plan delivered the first ever 100% successful clinical run for our Client, while attaining on the highest products yields, therefore enabling the expansion of clinical trials.

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Resource Optimization

Goals and Business Driver:

Our client wished to identify proposed headcount targets and required efficiencies at specified run-rate targets to enable a 50% reduction in cost per gram by year end. The overall process and implementation of the plan required engagement of the department management.

Discovery & Design

Enterey was brought on-board to identify these headcount requirements in order to assist the client with their wider goal.

Implementation

Enterey consultants determined the optimal organizational structure to achieve the specified run rates and benchmarked data against other sites. Our team then developed a customized matrix model of run rates and headcount by department, leading to a proposal of required efficiency to enable headcount reduction with increased span of control.

Results Achieved

The identification of headcount targets enabled our client to reach improved operational performance goals, with no impact to business operations. As a result of this effort, opportunities for staff to improve and build skill sets were increased, and opportunities for displaced employees were identified. 

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PPM System

Goals and Business Driver:

The company did not have a holistic and transparent view of current activities (both current operations and projects) to support strategic level decision making for their sole biologics manufacturing facility. The client goal was to develop a portfolio management program (processes, tools and templates) that would standardize and increase efficiency of project methodologies, provide transparency and visibility to internal and external workflows and enable executive level decision making that is clearly aligned with strategic objectives.

Discovery & Design

Enterey was brought on-board to create this portfolio management system.

Implementation
  • Defined current state portfolio of projects
  • Developed and formalized a standard methodology for individual project management
  • Developed and formalized a methodology for overall portfolio management 
  • Developed key tools and templates, including intake form, charter template, status update form, request to close form, benefits realization form
  • Developed a fully automated portfolio dashboard
  • Developed supporting processes (e.g. Issues Escalation)
  • Established formal Portfolio Management process cadence
Results Achieved
  • Significantly improved transparency and visibility of all ongoing site activities (estimated increase from ~10% visibility of current activities for the executive leadership team to a >90% visibility)
  • Fully enabled strategic level decision making in support of clearly stated strategic objectives
  • Decreased documents associated with portfolio from ~137 to 1
  • Decreased individual project leads required data input by ~47%
  • Improved status update timeliness by ~300%
  • Provided an annual PPM cost savings of ~$130,000
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Capital Management

Goals and Business Driver:

Our client was reorganizing due to a separation event and required a structure to manage capital projects in the Regulatory function, with specific focus on aligning the IT, Business and Project Management Teams. 

Discovery & Design

The Enterey consultants were brought in to support the client in the definition of portfolio governance structure, roles and responsibilities (R&R), project management methodology, templates and capital budget tracking.

Implementation

Our team facilitated workshops aimed at refining the stage-gate requirements and defining accountability for all project deliverables across functions. Enterey consultants built and delivered customized tools and templates for project management deliverables, covering each phase from business case creating to closeout, including a new capital portfolio tracking tool. To ensure alignment with and commitment to the new model and role definitions, a special focus was given to change management and involvement of stakeholders.

Results Achieved

The increased level of clarity led to a reduction in time devoted to portfolio governance by 75%. The establishment and implementation of defined framework and R&R followed by each project ensured consistent alignment and accountability. New roles were successfully adopted by IT, Business and PM team members, with a feedback loop to enable continuous improvement in adherence to Project Management Office requirements.

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Plant Transfer

Goals and Business Driver:

Our client acquired a large biotech manufacturing plant nearing construction completion. Enterey consultants were brought onboard to support the need to integrate the new site and employees into its operations to address significant demand concerns. Aggressive deadlines were set to ensure the new plant was producing marketable product within the targeted time frame.

Discovery & Design

Enterey was brought on-board to ensure product deadlines were met and employees were integrated efficiently. 

Implementation

Enterey consultants determined focus areas, as part of an overall program, and created specific project plans for their integration. Decisions were made about the systems and processes the new site would either adopt, integrate with or keep unchanged. Our team provided project management support to 3 key business areas.

Results Achieved

Our client successfully completed the transition of the new site, according to the schedule. The new site not only integrated with corporate, but also had established plans to complete the integration of all business areas. The success of this transition enabled the site to focus intently on the transfer of new product technology into the facility.

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Acquisition Integration

Goals and Business Driver:

Our client initiated a $9B acquisition and brought Enterey consultants on board to support the goal to fully integrate and ensure operation and compliance of both quality systems and regulatory processes within 9 months.

Discovery & Design

Enterey was brought on to ensure operation compliance of quality systems and regulatory processes.

Implementation

Our team assessed the effort, clearly scoped the responsibilities into a new project workstream structure and worked with the client to create an integrated project plan with a detailed work breakdown structure and a timeline adhering to the overall project completion date assigned by upper management.

Results Achieved

Our client successfully kicked off fifteen projects during the first phase of this program. The establishment of the PMO enabled monitoring progress and issues of each project, and regularly reporting on their status to the Steering Committee. Over $2M of efficiencies were identified during the first phase of the program.

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Site Integration

Goals and Business Driver:

Our client acquired a large biotech site and marketed product from another global pharmaceutical manufacturer. Enterey consultants were brought onboard to support the need to integrate the new site and employees into its operations while ensuring the company seamlessly continued manufacture of its newly acquired product as well as four contracted products.

Discovery & Design

Enterey was brought on to support the integration of the new facility and ensure a smooth transition.

Implementation

Our team designed detailed project and communication plans, set key milestones and developed project teams to ensure completion of the construction phase of the plant, manufacturing setup and transfer of the antibody. Enterey consultants provided key project management support for both the lead project manager of the receiving plant, who reported into the site leadership team, and for site preparation for regulatory inspections by the state, FDA and EMEA.

Results Achieved

With Enterey consultants’ support and guidance, our client completed on time construction, plant commissioning and commercial product manufacturing activities. These led to successful state, FDA and EMEA approvals within the initial project timeline.

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Facility Startup

Goals and Business Driver:

Our Client commissioned two new plants to be built on the West and East Coasts to be strategically located, in order to streamline their supply chain and better service their patients. Mid-way through construction, the newly hired Vice President and General Manager assessed the plant build-outs were each four months behind schedule from the corporate timeline for regulatory approval, and decided to bring Enterey onboard to manage the effort.

Discovery & Design

Enterey was brought on-board to identify ways to ensure the facilities met their buildout timelines.

Implementation

Enterey consultants carefully managed key decisions and activities from construction turnover through regulatory approval. Our team engaged with key stakeholders to ensure alignment of objectives and to create practical solutions that could be implemented rapidly. By fully characterizing the existing gap and setting key milestones with the project core-team, Enterey consultants developed a detailed execution plan, and ensured all critical deadlines were met.

Results Achieved

Our Client was able to close the gap and get both plants fully qualified on-time. With Enterey consultants’ close monitoring and guidance, deadlines were met and regulatory approvals were gained, resulting in an on-time commercial licensure which provided a net gain of over $100MM in captured revenue for our Client. 

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Facility Transfer

Goals and Business Driver:

Our client anticipated rapid growth of operations and had plans to move to a significantly larger facility. They were aware that, in order to achieve the expanded scale necessary to operate the new facility, they must improve existing business processes and eliminate inefficiencies. This process improvement the goal of the project.

Discovery & Design

Enterey was brought on-board to identify ways to improve existing business processes in order to acclimate to the expanded scale of their new facility.

Implementation

Enterey consultants facilitated collaborative sessions with client stakeholders, identifying projects and scoping a phase-gate approach to enable the company to achieve the necessary process improvement in alignment with the facility construction timeline. Our team supported the creation of  a Project Management Office (PMO) to establish governance and organization to all the projects.

Results Achieved

Our client successfully kicked off fifteen projects during the first phase of this program. The establishment of the PMO enabled monitoring progress and issues of each project, and regularly reporting on their status to the Steering Committee. Over $2M of efficiencies were identified during the first phase of the program.

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Partner Collaborations

Goals and Business Driver:

Our client was collaborating with multiple partner companies to test combination therapies in clinical studies. Due to the lack of a robust business process to integrate partner documents and data into their regulatory, manufacturing and distribution systems, our client experienced delays to supply for trials. They identified a primary goal as minimizing disruptions to mitigate delays in supply.

Discovery & Design

Enterey was brought in to assist with the process of partner collaboration in order to minimize disruptions in supply and allow for smoother operations going into clinical trials.

Implementation

Enterey consultants quickly identified the pain points and focused on Planning, Quality and Regulatory to address these issues. In addition to completing an end-to-end process map linking the required documentation to the systems, our team also built a project management tool that ensured visibility to where all Partner Collaboration project stood with relation to supply.

Results Achieved

Our Client has leveraged this process since then, to prevent any supply disruptions. The Client also benefited from the improvement in their relationships with Partners, due to better communication around documentation requirements.

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Manufacturing Streamlining

Goals and Business Driver:

Our client recently commissioned two new plants to streamline supply chain processes. Halfway through construction, it was identified that both plants were 4 months behind schedule from the corporate timeline for regulatory approval. The goal of the project was to ensure both facilities met regulation on time.

Discovery & Design

Enterey was brought on board to carefully manage key decisions and activities, from construction turnover through regulatory approval, and ensure critical deadlines were met. Enterey consultants fully characterized the existing gap, set key milestones with project core-team, and developed a detailed execution plan.

Implementation

Enterey worked with key stakeholders to gain alignment of objectives and to create practical solutions that could be implemented rapidly.

Results Achieved

The team was able to close the gap and get both plants fully qualified on time. With Enterey's close monitoring and guidance, deadlines were met and regulatory approvals were gained, resulting in an on-time commercial licensure, which provided a net gain of over $100M in captured revenue.

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Inspection Readiness

Goals and Business Driver:

Following completion of construction and plant commissioning, our client set timelines to license its new facility and to pass all the required inspections, including State, FDA and EMEA Pre-Approval Inspections. The project goal was ensuring the new facility met these inspection criteria.

Discovery & Design

Enterey was brought in to ensure the new facility met inspection criteria by working with the internal Quality Team to identify and amend gaps in the facility's Quality System.

Implementation

Enterey consultants performed a gap analysis and provided action plans to remediate or defend the gaps identified in the plant’s Quality System. Our team provided project management support to the 14 departments throughout the plant and to the Director of Quality Assurance. In addition, our team ensured regular communication by providing updates to the Corporate Compliance and the GMP Core Team.  Enterey consultants also supported the staff during the inspections as related to defense strategies, documentation and final inspection room preparation.

Results Achieved

Our client’s facility was licensed as planned and both the State, FDA and EMEA inspections were successful. Only minor observations were issued by the State and EMEA, while there were no FDA observations. Action plans to correct the minor observations were timely and successfully implemented.

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