Pharma and medical devices.
Singlepoint has been used in the pharmaceutical and medical device industries for over 20 years, supporting organizations with the controlled quality processes, documents and records required in highly regulated environments.
Automate and streamline quality management
Singlepoint meets the requirements of 21 CFR Part 11 for electronic signatures and approvals, while its built-in Competency Checker verifies user understanding of important documents and connects this with training and skills management. Singlepoint can also help automate and streamline Advanced Product Quality Planning (APQP) processes.
Customers use Singlepoint to help manage GMP, ISO 13485, ISO 9001, ISO 14001 and ISO 45001 requirements, making the platform a key part of their wider quality management strategy.
With enterprise-wide control of documents, processes and data, pharmaceutical and medical device organizations can manage and track important information while supporting compliance and reducing the risk of errors.
Give employees easy access to controlled information
Singlepoint's user-friendly interface allows employees to quickly find and access the information they need, helping improve productivity and engagement while making controlled information easier to use in day-to-day work.
Verify employee understanding
Singlepoint's built-in Competency Checker verifies that employees have understood important documents and links this with training and skills management. This provides greater visibility of workforce competency and helps identify where additional training may be required.
Make informed decisions
Best practice and compliance are built into Singlepoint's controlled digital processes, helping organizations meet relevant industry standards. Singlepoint Business Intelligence provides real-time access to important information so teams can monitor performance and make informed decisions.
How pharmaceutical and medical device teams can use Singlepoint
For end users
Employees can quickly find and access current, controlled information relevant to their roles. Singlepoint also helps organizations verify that important documents have been understood, rather than simply recording that employees have accessed them.
For QHSE teams
Singlepoint helps QHSE teams automate and control processes including internal audits, corrective and preventive action, calibration, document control, training and lessons learned. Comprehensive records and audit trails help reduce administration while keeping quality and compliance information audit-ready.
For engineering teams
Engineering teams can collaborate across disciplines while managing processes such as APQP and PPAP, New Product Introduction and Engineering Change Management. Controlled workflows help teams manage changes, approvals, evidence and implementation while maintaining traceability throughout the process.
In manufacturing and operations
Employees can access accurate, up-to-date documents and other controlled information needed to carry out manufacturing processes. Singlepoint can also integrate with ERP, CRM and other business systems, helping connect quality processes with the wider manufacturing environment.
In customer service
Customer service teams can manage customer-related processes within controlled workflows and access relevant information from connected systems. This can help teams manage customer issues consistently and maintain a clear record of actions and resolutions.
For HR and training teams
Singlepoint gives HR and training teams visibility of employee skills, training requirements and competency gaps. Training Management and the built-in Competency Checker help teams plan and track training while verifying employees' understanding of important controlled documents.
In commercial teams
Commercial teams can access relevant quality and operational data and contribute to controlled processes where required. This gives them greater visibility of information that may affect customers, products and wider business activity.
For senior management
Singlepoint Business Intelligence gives senior management real-time access to business-critical quality, compliance and operational data. Reports and dashboards provide greater visibility of performance and help leaders identify issues, trends and opportunities for continuous improvement.
Compliance teams
Compliance teams can use Singlepoint to maintain controlled processes, records and evidence across the organization. Electronic signatures and approvals support 21 CFR Part 11 requirements, while document control, competency records, audits and change management help maintain traceability and audit readiness.
Schedule a free demo
Find out how Singlepoint can help your pharmaceutical or medical device organization improve processes, reinforce a culture of compliance and drive quality across your operations.
Designed to support pharmaceutical and medical device organizations
Singlepoint's Quality Management System offers a range of features and modules designed to support key quality, compliance and operational processes within pharmaceutical and medical device organizations.
Visual Navigator
Singlepoint Visual Navigator gives employees quick and easy access to the information they need, making complex layers of controlled quality information easier to navigate and supporting greater efficiency and compliance across day-to-day operations.
Document Management
The Document Management module provides controlled management and distribution of documents and other media, helping ensure employees have access to current, approved information. Comprehensive document histories and audit trails also help pharmaceutical and medical device organizations maintain evidence of document control.
Issue Management
Singlepoint Issue Management provides end-to-end management, control and resolution of issues such as customer complaints, audit-related nonconformances and health and safety incidents. Issues and associated actions can be managed through a controlled process from identification through to resolution.
Audit Management
The Audit Management module provides a fully digital process, including an offline-capable app, for managing system, product and process audits. Teams can manage findings and related nonconformances within a controlled process while maintaining the records needed to support audit readiness.
Calibration Management
The Singlepoint Calibration module provides full lifecycle records management for gauges, equipment and other assets, along with a comprehensive audit trail and future schedule planning. This helps teams maintain visibility of calibration status and associated records across regulated manufacturing environments.
Training Management and Competency Checker
Singlepoint Training Management helps organizations identify gaps in employee skills and competency and plan, execute and track training to address them. The built-in Competency Checker verifies employees' understanding of important controlled documents, providing evidence that information has been understood rather than simply accessed.
Lessons Learned
Singlepoint Lessons Learned module provides a searchable knowledge base where teams can capture knowledge from previous experiences and applied solutions, making valuable learning available to inform future products, processes and quality activities.
APQP and PPAP
Singlepoint APQP and PPAP provides an automated, data-driven approach to managing these detailed processes, helping teams coordinate activities, information and supporting evidence while maintaining visibility of progress.
New Product Introduction
Singlepoint NPI Management provides project managers and team members with a collaborative workspace to manage tasks, timing and risk, upload work and supporting evidence, and record progress throughout the introduction of new products.
Change Management
Singlepoint Change Management provides an end-to-end, workflow-based process for managing changes to products and processes. Teams can capture the reason for proposed changes, manage reviews and approvals, record decisions and evidence, and maintain a complete audit trail of investigation and implementation activity.
Business Intelligence
Singlepoint Business Intelligence provides real-time access to quality, compliance and operational information, helping teams monitor performance, identify trends and use data to support informed decision-making and continuous improvement.
Get our QMS fact sheet
Download our fact sheet to learn more about how Singlepoint’s quality management software can help you.
Our pharmaceutical case studies
CooperVision: Transforming a manual complaint process
Discover how CooperVision transformed its customer complaint handling from a cumbersome manual ordeal into a dynamic, automated system with the integration of Singlepoint, boosting efficiency and visibility across the board.
KRG: Reduced costs and improved reporting with Singlepoint
As one of the UK’s top precision engineering firms, KRG Engineering faced steep administration costs that threatened its operational efficiency. Enter Singlepoint QMS, which, with its suite of advanced modules, transformed the firm’s approach.
NGF: A decade of support
NGF Europe Ltd are one of the world’s largest manufacturers of glass and glazing products for architectural, automotive and established creative technology markets.
Acdopro: Document Control, Issue, Calibration & Visual Navigator
Acdopro have been using Singlepoint since May 2020. They specialise in the manufacture of laundry products exported to over 75 countries, under well-known trademarks such as Dr. Beckmann, Glo white, Stain Devils and ACDO.
Pharmaceuticals FAQs
How does Singlepoint support 21 CFR Part 11 requirements?
Singlepoint meets the requirements of 21 CFR Part 11 for electronic signatures and approvals, helping pharmaceutical and medical device organizations manage these activities within controlled digital processes. This can form part of a wider approach to maintaining electronic quality records and supporting compliance in regulated environments.
How can Singlepoint support ISO 13485 requirements?
Singlepoint can support medical device organizations with quality processes relevant to ISO 13485, including document control, audits, issue management, employee competency, calibration and change management. Controlled workflows, records and audit trails help organizations maintain evidence of how these activities are managed and support ongoing audit readiness.
How does Singlepoint help manage employee training and competency?
Singlepoint Training Management provides visibility of employee skills and training requirements, helping organizations identify gaps and plan and track training. Its built-in Competency Checker goes further by verifying whether employees understand important controlled documents, providing evidence of understanding and identifying where additional training may be needed.
How does Singlepoint support change management in pharmaceutical and medical device organizations?
Singlepoint Change Management provides a controlled, workflow-based process for managing changes to products and processes. Teams can capture the reason for a proposed change, manage reviews and approvals, record decisions and supporting evidence, and maintain a complete audit trail through investigation and implementation.
Which Singlepoint modules are useful for pharmaceutical and medical device organizations?
Singlepoint QMS offers a range of modules for regulated pharmaceutical and medical device environments, including Visual Navigator, Document Management, Issue Management, Audit Management, Calibration, Training Management and Competency Checker, Lessons Learned, APQP and PPAP, New Product Introduction, Change Management and Singlepoint Business Intelligence. Together, these capabilities support quality, compliance and operational processes across the organization.