Challenge: To grow efficiently with excellence while growing rapidly

To support their dynamic growth plans, Collagen Solutions searched for a comprehensive, integrated system to streamline and automate their business processes, recordkeeping, and reporting of their quality management and R&D design controls. Anticipating the volume of master records and transactions would be accelerating, they wanted a solution to ensure accurate business logic, the ability to quickly search for a rapidly expanding volume of records, plus responsive performance reporting for all stakeholders. For a dynamic life science products provider, these capabilities must be well maintained and adaptable to sustain regulatory compliance, effective product development, and wise performance monitoring as the business scales up. Finally, the highly innovative nature of the products being developed and manufactured for clients adds an extra degree of complexity for the staff to effectively manage vital information day in and day out.

Quality Management Document Control

There is a clear need to harmonize document management for planned acquisitions as well as those of the legacy international sites in the growing enterprise. Collagen Solutions requires a sophisticated system that can tightly manage revisions, automate formatting, and enable lightning-fast lookup of QMS and Design Control documents.

Corrective Action Preventative Action (CAPA) Processing

With a rapidly evolving global team, whenever a CAPA needs to be initiated, it is vital for the right people in the right roles to be engaged consistently in the right order. With the outcomes of CAPA workflows being critical to patient health and safety, automation and flexible business logic are essential to assure that stakeholders always are notified, called to action under various conditions, and ultimately informed of results when the CAPA is resolved.

Checklists and Recordkeeping Forms Management

With a growing number of test protocols, lab reports, production batch records, and certificates of compliance to manage, two considerations are important. First, assure quick recall when these records are to be reviewed or referred to, and second, facilitate access to the valuable information captured in these records to identify trends and anomalies. So, having these forms established in a searchable database is important and empowering for the experts and other stakeholders.

Design Controls

As the pace of technologies and the number of products being developed ramps up, a common platform for managing design activities and risk analyses must be able to integrate comprehensive matrices under revision control as R&D engineering and testing progress through various gate reviews.

The solution is the mechanism to effectively and efficiently manage critical information

Collagen Solutions searched for a strong solution able to address both Quality Management and Design Controls to complement the large-scale Enterprise Resource Planning (ERP) system being implemented to manage production activities. SoftExpert Suite is utilized to manage assignments, track results, and enable data-driven decision-making for day-to-day operations across several continents. Corrective Action and Preventive Action (CAPA) and Non-Conformance Reporting (NCR) are managed alongside the company's corporate Quality Manual and Operating procedures are available to all worldwide stakeholders to deliver clarity, compliance, and effective decision-making. From executives, leaders, and workers in operations and quality to the R&D team, everyone has quick online access to important documents and forms for information and daily use such as work instructions, protocols, checklists, and certificates, as well as inspection and production batch record forms. Users are able to log in via PCs, laptops, and tablets to capture important information, check statuses, and monitor KPIs. They can also quickly initiate CAPAs and NCRs at the push of a button to immediately report occurrences that are consistently routed to responsible team members. The logic makes standardized assignments to identify containment steps, root causes, and corrective/preventive action plans followed up with verification of successful resolution. These repeatable workflows feed real-time tracking and KPIs depicting progress, status, and trends to help assure quality and compliance plus inform leaders of opportunities for improvement. Additionally, the product development team now has integrated design controls featuring a dynamic trace matrix with multiple reports. The entire design concept is modeled displaying relationships between requirements, inputs, outputs, verification, and validation planning based on hazards and likely harms. This enables the R&D engineers and scientists to prioritize their focus on the design inputs and outputs with the greatest risks to patients and clinicians to be mitigated and eliminated. In addition, the critical documents supporting each of these design considerations are linked directly to the various design parameters in each trace matrix.

The Return on Investment (ROI) for Collagen Solutions in this Project

Document Revision Control and Publication

Quality and Design documents are securely stored and maintained under tight revision control. Only document authors can edit documents so responsible specialists and leaders are consistently assigned to review and sign off on the changes. When there is an audit, the team can quickly recall any revision due to the traceable nature of the history records. This helps to speed the audit process and minimize follow-up actions to address open questions and findings.

CAPA and Non-Conformance Report Workflows

When users can quickly initiate these processes to address occurrences and assign follow-up tasks with reminders to the stakeholders, remediation, and recovery are consistently successful. This minimizes wasting of time and resources and enables automated status reporting for leaders to be effective process owners

Dynamic Design Controls Trace Matrix

With the built-in stage-gate design reviews of up-to-date information and stored revision history, the engineers, executives, and consultants have a complete picture of the entire design hierarchy and its changes over time. This minimizes the risks of design errors due to reliance on dissociated files stored on their network while trying to keep the overall process under manual control.

Multiple Reporting Dashboards By Site and Enterprise

The process owners and leaders have enhanced dashboards and reports tailored to the needs of users in various countries. This flexibility allows adaptation to local terminology and legacy methods enhanced with corporate best practices to build acceptance of the new solution and value for all stakeholders in the company.

Medical Device and Operational Management Built for Quality Assurance

SoftExpert is a robust and flexible software solution for biotech and life science providers. With SoftExpert, your Product Development, Quality, Purchasing, Production, and Logistics teams can remain in sync to ensure success in meeting your customer’s requirements while remaining in compliance with patient safety and regulatory requirements. SoftExpert Professional Services team provides quick implementations utilizing our template database and rapid application deployment methods guided by industry best practices. When the solution is live, your team will be able to maintain and enhance the processes set up in the system. This means you do not need to be a software programmer nor be dependent on support from our staff. The combination of custom-configured home screens and dashboards plus SoftExpert’s on-demand learning resources enable your employees to quickly engage to use the system successfully to manage your business processes.

FDA 21 CFR Part 11

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