Pharma and medical devices.

Singlepoint has been used in the pharmaceuticals and medical devices industry for over 20 years.

Quality management systems Quality management systems
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Automate and streamline quality management strategies

Singlepoint meets the requirements of 21CFR Part 11 for electronic signing and approvals, and its Competency Checker module verifies user understanding of documents and links back to training and skills management. It can also help automate and streamline Advanced Product Quality Planning (APQP) processes.

Customers use Singlepoint to manage GMP, ISO13485, ISO9001, ISO14001, and ISO45001 compliance, and for many of them, it is a key part of their quality management strategy.

  • GMP
  • ISO13485
  • ISO14001
  • ISO45001

With enterprise-wide control of documents, processes, and data, companies can efficiently manage and track important information, ensuring compliance and reducing the risk of errors.

User-friendly interface

Singlepoint’s user-friendly interface allows employees to quickly find and access the information they need, improving productivity and engagement.

Competency Checker module

The system’s Competency Checker module verifies that employees understand and are trained on important documents, ensuring compliance and reducing risk. Its change management capabilities allow companies to efficiently track and manage changes to products and processes, ensuring smooth and timely implementation.

Make informed decisions

Best practice and compliance are built into Singlepoint’s digital process execution, supporting compliance with industry standards. The system’s real-time business intelligence capabilities allow companies to quickly access important information and make informed decisions.

End users benefit from Singlepoint’s easy-to-navigate and always-up-to-date information, helping them to save time, improve accuracy, and reduce risk.

For QHSE teams:

Singlepoint's fully automated and fully in-control approach can save time and resources, and help to ensure that your organisation is "audit ready" every day. With full automation and control of key processes such as internal audits, corrective/preventive action, calibration, document control, training, and lessons learned, QHSE teams can greatly streamline their operations and support compliance.

Engineering teams

Can ensure real-time collaboration across disciplines, combined with automation of processes like APQP/PPAP, NPI, and engineering change control, can help engineering teams design, innovate, and deliver products and services more efficiently.

In manufacturing & operations:

Singlepoint’s digital approach can provide tangible benefits, such as easy and quick access to key documentation that is guaranteed to be accurate and up-to-date. The system offers seamless integration with ERP/CRM and other tools, supporting efficient and effective processes.

In customer services:

Singlepoint provides tools that support key processes and can execute them with total control and efficiency. The system offers seamless integration with ERP/CRM and other tools, helping you to provide top-quality support to your customers.

For HR & training teams:

Singlepoint offers full visibility into each employee’s knowledge journey, including roadblocks, gaps, and solutions. This can help you to provide targeted and effective training support to your employees.

In commercial teams:

Singlepoint allows you to be fully embedded in key processes, providing you with access to data and control over key processes. This can help you to support the success of your business.

For senior management:

Singlepoint offers huge savings in terms of time and efficiency, along with instant access to business-critical data that can support decision-making and drive continuous improvement.

Compliance teams

Can use Singlepoint’s NPI & APQP modules to drive savings in terms of time and resource, alongside ensuring systems and information are kept ‘audit ready’.

Schedule a free demo

Find out how we can help your organisation improve processes, reinforce a culture of compliance and drive quality from a single source of truth.

Designed to support pharmaceutical and medical devices organisations

Singlepoint to support a range of key processes and operations within pharmaceutical and medical devices organisations:

Visual Navigator

Our unique Visual Navigator allows users to quickly and easily access and navigate the Singlepoint, supporting higher levels of compliance and greater efficiency and productivity.

Document Management

The Document Management module provides compliance-strength control and distribution of documents and other media, ensuring that the right information is delivered to the right person at the right time.

Issue Management

Our Issue Management module offers end-to-end management, control, and resolution of any and all “issue” types, such as customer complaints, audit-related non-conformances, and health and safety incidents/accidents.

Audit

The Audit module offers a fully digitised process, including an offline-capable app, that delivers a comprehensive audit and non-conformance solution. This is ideal for system and product/process audits.

Calibration

The Calibration module provides full lifecycle records management of gauges, equipment, and other assets, along with a comprehensive audit trail and future schedule planning.

Competency Checker

The Training Matrix and Competency Checker modules offer a comprehensive skills and training management system that helps you to identify gaps in your employees’ competency levels and plan, execute, and track training events to address those gaps.

Lessons Learned

The Lessons Learned module provides an all-access knowledge base that can help your employees learn from historical experiences and applied solutions.

APQP

The APQP/PPAP module offers a fully automated and data-driven approach to streamlining this labour-intensive but valuable process.

New Product Introduction

The NPI Management module provides a collaborative workspace for project managers and team members to see tasks, timing, and risk, and to upload work and evidence and record progress for a real-time “one version of the truth” view.

Engineering Change Management

Our Change Management module offers an end-to-end, workflow-based solution for capturing the reason for proposed changes, reviews and approvals, decisions, evidence, and a full audit trail of investigation and implementation activity.

Business Intelligence

Our Radar BI module provides real-time, effortless access to invaluable management information to support better decision-making and continuous improvement.

Get our QMS factsheet

Download our factsheet to learn more about how Singlepoint’s quality management software can help you.

Our Aerospace case studies

The Mentholatum Company: Document Management

The Mentholatum Company: Document Management

The Mentholatum Company, a US-based developer of OTC products, faced challenges with document management and regulatory compliance under FDA and cGMP guidelines. Adopting Singlepoint’s Document Management System, they transformed their paper-based system into a digital powerhouse, enhancing document security, access control, and audit readiness.

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Hitachi Rail: Multi-site implementation

Hitachi Rail: Multi-site implementation

Hitachi Rail Europe, Ltd. is a wholly owned subsidiary of Hitachi, Ltd. and a total railway system supplier offering rolling stock, traction equipment, signalling, traffic management systems and maintenance centres.

read more
Fablink: NPI and APQP

Fablink: NPI and APQP

Fablink redefines project management in the automotive industry with Singlepoint, gaining total visibility into NPI and APQP tasks

read more