Beaufort Solution: These actions included a review and revision of its Quality Document System, a review of its Computer System Validation (CSV) Plan, and performing Vendor Audit Assessments. Beaufort performed an in-depth review of the company’s current document system, including meetings with all key stakeholders. This review led us to suggest several alternative document structures. The final project deliverables included an SOP Assessment Report, complete Document Index, revised SOPs, Flow Diagrams, Glossary of Terms and Definitions and an SOP Writing Style Guide.
Beaufort Solution: Beaufort conducted these audits on behalf of the company, which allowed the company to make informed decisions as a clinical trial sponsor. This client has since requested Beaufort’s additional support in developing a Quality System and assisting with its 510(k) submissions.
Beaufort Solution: The client sought assurance that clinical data was valid and could support a PMA submission. Lacking sufficient internal resources, the client selected Beaufort to conduct the assessments. Beaufort planned and audited two clinical sites and worked with the client to gain historical information regarding site staff and data collection. Beaufort recommended performing an audit of the sponsor’s trial master file prior to auditing clinical sites, thus ensuring that the sponsor held required regulatory documents for each site. Beaufort provided audit reports and held subsequent discussions with the client, enabling it to make informed decisions regarding the integrity of data associated with the clinical trial. The output of these audits provided the client assurance that its required study files were in order for potential FDA inspection following the submission of the PMA.
Beaufort Solution: Realizing it had insufficient internal resources, the Quality Assurance division sought assistance in transitioning from a paper-based document system to a software-based document control system. Beaufort performed an initial review of its system to identify any existing gaps. This effort included a review of approximately 670 SOPs and 350 forms for content including obsolete references; document relevance; assignment of appropriate ownership/responsibility; and potential for SOP deletion, modification, or combination. In addition, Beaufort worked closely with functional areas to gain an understanding of the numerous processes and how they were potentially linked. This assignment led to a follow-on SOP project.
Beaufort Solution: Beaufort addressed numerous gaps with the client’s design control system to establish root causes, corrective and preventive action (CAPA) plans, and effectiveness verification checks. Specific gap-closure activities included procedure generation, training, Design History File (DHF) creation, and records review related to all aspects of design controls. Work involved interfacing with and engaging numerous site personnel having limited knowledge of regulatory regulations. The project was further challenged with aggressive business priorities that competed with the same personnel and involved multiple sites. Beaufort was instrumental in closing these gaps through a unique blend of hands-on involvement, training through mentoring, and great flexibility. Our collaboration and work with this client ensured it was capable of meeting regulatory and corporate requirements without impacting business objectives.
Beaufort Solution: Beaufort’s QA team conducted an analysis of all the possible chemical interactions of all the components of the client nine different formulations and developed a cross-contamination matrix. Concurrently, all possible equipment configurations were classified by total product contact surface area. Working directly with our client’s corporate R&D and QA teams and their manufacturing site team, we facilitated cross-functional failure mode and effect analysis (FMEA) workshops and analysis efforts to identify worst cases based on risk. We also developed the new Cleaning Validation Strategy, created all the engineering studies and validation protocols, and identified improvements using statistically sound sampling plans, visual and readily available work instructions, and hands-on training of all personnel involved with the cleaning process. As a result, our client has a fully developed strategy and executable master plan to validate an efficient, better performing cleaning process with all the documented evidence to prove it.
Beaufort Solution: The acquired global business unit had a validation process that was different and did not meet the global validation requirements of the parent corporation. We performed a “deep dive” assessment of its validation process: from the technical and compliance assessment of the original validations, through its current process and approach, to the gap analysis for implementing a new validation process that met all the requirements of the new parent corporation.
The assessment confirmed that there was an opportunity to create a competitive advantage by minimizing compliance risks and improving operational performance of the new business unit by the implementation of a new validation process designed according to the latest industry standards that meets all requirements of the parent corporation. The Beaufort QA team, working side by side with its validation, quality, and engineering teams, developed the new Validation Master Plan, updated all of the documentation, facilitated the required training, and identified all the implementation mechanisms for ensuring a successful integration of the new validation system and the execution of the required re-validations at the newly acquired business unit.
Beaufort Solution: The Beaufort QA team conducted a comprehensive technical assessment and applied the DMAIC methodology and five Whys in order to perform and document a comprehensive root cause exercise. Concurrently, a statistical analysis was conducted on all available historical and current year performance data and we were able to determine that the system was performing as designed and in a “state of control” against our client’s process specifications. Then a process failure mode & effect analysis (FMEA) was executed in order to evaluate each risk and provide a solid base for solution development and prioritization.
Based on the information developed and working directly our client’s team (operators, lab technicians, maintenance mechanics, QA personnel, and process engineers) and the support team from its purified water system technical supplier, we designed an overall solution that addressed all of the critical/high risk technical deficiencies identified in the FMEA stage and then developed a re-validation/implementation plan that will be executed during the plant’s next maintenance shutdown. As the project progressed, all deficiencies that required immediate attention were submitted to change control and properly resolved, and a software validation master plan for the control system was developed with all its diagnostics/statistical tools fully functional. The overall project did not only provide our client with a fully compliant purified water system but it has the potential to generate significant operational savings after implementation.
Beaufort Solution: Beaufort assisted the client in formulating a new strategy that would support the validation of a new e-beam sterilization process while meeting upcoming requirements of future products with improved service levels and reduced cost requirements. We then facilitated the selection of a new sterilization services supplier who could meet the cost and service level requirements and assisted the client with the certification the new approved supplier. As a result of the project, the client is able to accommodate significant new growth within its existing footprint and reduced the complexity of its supply chain using a highly efficient sterilization process at a significant cost savings and also improved their cycle time and customer service levels.
Beaufort Solution: The acquired global business unit had recently implemented an ERP system that was different and did not meet the global system requirements of the parent corporation. Our evaluation considered the current and projected use of the global ERP system, the underlying business drivers for it, the implementation time frames and ability of the acquired unit to meet the new corporate software requirements. Our assessment confirmed that there was superior value in improving and re-validating the business unit’s ERP system and identified mechanisms for ensuring that re-validation and integration was fully compliant and met all the software requirements of the parent corporation.
Beaufort assembled a software validation and implementation team that not only worked with the IT team of the newly acquired business at its HQ office, but had sub-teams deployed at each strategic global location. By taking this approach, we were able to provide our client a global best solution that addressed all of the corporate and integration requirements at the HQ office and took into consideration all the operation needs at each site. Our team was able to improve, integrate, and revalidate a global ERP system that met all the requirements of the new parent corporation within schedule and below budgetary guidelines.
Beaufort Solution: While the new system promised to help automate packaging inspection and final product disposition, our client was concerned that the technical limitations of the existing equipment on each packaging line and its engineering team expertise were not efficient enough and unable to fully capitalize on the capabilities of the new system. We facilitated cross-functional (packaging materials supplier, validation technician, quality technician, process engineer, and maintenance staff) team meetings and ongoing design and testing analysis reviews covering the critical performance qualities of an automated inspection process to identify deficiencies with the current equipment and process, and developed all the engineering studies and validation protocols.
As the project progressed, our team also identified several process improvement opportunities to lower cost, reduce cycle time and enhance the quality of the client’s packaging process. The validation plan was rapidly adjusted to incorporate these improvements into the validation protocols and training regimen. As a result, once the technical upgrades on each packaging line and the specialized training are completed, our client has a fully developed and executable plan to validate an efficient, better performing packaging process that was standardized and optimized to take full advantage of the capabilities of its new vision and optical recognition system.
Beaufort Solution: A majority of the company’s clinical and regulatory staff had never participated in a regulatory inspection and anxiety levels were running high. Beaufort began the project by interviewing all pertinent personnel to establish its experience level and determine the company’s preparedness for the inspections. Our work included extensive document reviews, mock audits, extensive training sessions, both seminar and one-on-one. Beaufort also developed white papers to share with regulatory authorities during the inspections. We developed a series of mock inspections and follow-up activities, and the client passed all regulatory inspections with minimal audit findings, including a major FDA pharmocovigilance inspection.