Validated Cloud-Based eQMS

for the Pharma Industry

✓ GxP Compliant & Validated

✓ Efficient Training Management

✓ Easy Deviation & CAPA Tracking

What SimplerQMS Offers

Document & Change Control

Managing your documentation in a manual system can cause inefficiencies and result in non-conformances. SimplerQMS automates and simplifies your document control process:

  • Work on your documents directly in Microsoft Office. They are automatically named, versioned, and stored in the secure cloud.
  • Documents are sent through a workflow for Authoring, Review, and Approval with Part 11 Compliant eSignatures.
  • Create templates in Microsoft Office and enforce the use of the latest template version.
  • Easily Track and Overview documents through Dashboards and Notifications – both from an employee’s and managers’ point of view.
  • Ensure that the right people have access to the right documents. Permissions can be controlled on many levels: By Person, Site Department, Process, Project, etc.
  • Easily create hyperlinks from documents to Products, Processes, Components, Suppliers, Customers, and Equipment.
Supplier Management

Ensuring that critical supplier documentation is present and up-to-date is a time-consuming task, which is prone to human errors. SimplerQMS helps you work more efficiently and with less risk by:
 

  • Enforcing a digital process for selecting, evaluating, qualifying, and monitoring your suppliers.
  • Automated to-do’s and notifications about pending supplier reviews, certificate updates, etc.
  • Process documents such as Supplier Assessment Forms, Supplier Audit Reports etc.
  • Build and maintain an approved supplier list.
  • Maintaining a repository of files from the suppliers (surveys, evaluations, certificates, forms, etc.)
Design Control & Quality by Design

Enable more efficient documentation of facilities, equipment and processes by:

  • Using approved Templates & Forms which are ready-to-use. 
  • Send documents such as Validation Protocols and Calibration Verifications through a pre-defined workflow.
  • Use our Dashboards to quickly gain an overview and access your documentation.
  • Make a ‘snapshot’ of your documentation with our Document Collection Tool.
  • Use a single repository for all your drawings, reports, notes, etc. and reference these to procedures, products, components, suppliers, equipment, and processes.
  • View all documents and approvals with versioning, audit trail, and electronic signatures.
Training Management

Ensuring that your training and documentation is compliant with regulatory requirements is time-consuming. SimplerQMS enables time-saving automation and tracking of training activities:

 

  • Easily build your Training Matrix by selecting the relevant trainable documents and employee job roles.
  • Employees automatically receive relevant training activities based on their job roles.
  • Dashboards provide an overview of the current training status – both from seen from the employees, managers, and the company’s point of view.
  • Reminders auto-scheduled and sent to employees before training activities become overdue.
  • Enable both self-learning and train-by-trainer activities with automatic issuing of training certificates.
Deviation Management

SimplerQMS will help you track activities and improve compliance by:

  • Easy recording of Non-Conformances, Deviations, Complaints, and Other Issues with automated linking and processing of Corrective and Preventive Actions (CAPAs) using Pre-Defined Templates (see Template Management).
  • Dashboard overviews of Issues, CAPAs, and Audits.
  • Export of PMS Data to Excel for further analysis.
  • Upload and Associate any document, file, record, and email with issues, audits, risks, and CAPAs as evidence.
  • Manage Audits and Audit Findings.
  • Easily create hyperlinks to Products, Components, Suppliers, Customers, and Equipment from any PMS Issue.
Risk Management

SimplerQMS allows you to consolidate Risk, Compliance, and Audits in one common system. Handle your Risk Management File by:

  • Recording and Assessing Risks
  • Performing Hazard Analysis
  • Building a Risk Management File
  • Create Hyperlinks from your Risk Management Documents to Products, Components, Suppliers, Customers, and Equipment.
  • Use simple Dashboards to create an overview of your Risk Documentation.
  • Get access to our audited 14971:2019 Risk Management Procedures and Forms.

The Implementation Process

Our project manager prepares a plan and helps assign your employees to key SimplerQMS processes. Further, an online design workshop is held where we complete the following tasks:

  • Review your current Quality Management System (QMS) content
  • Perform a GAP analysis by comparing your current content with the formal regulatory requirements
  • Review current document types, templates, existing quality manual, SOPs, Design History Files (DHF), and other relevant documentation
  • Walk you through configuration decisions which are documented in a user requirement specification
  • Capture requirements for migration of existing documentation to SimplerQMS

SimplerQMS is configured according to the user requirement specification including future document templates. A test version of SimplerQMS is made available for your users with agreed security settings.

These steps are completed during the Training phase:

  • We train your users in system access and all processes related to their job function.
  • All validation deliverables are archived and change control is enforced for both the test and production system

SimplerQMS is now ready for production. We are therefore ready to complete the following steps:

  • Migration of documents from the Quality Manual, Design History Files, and other relevant documentation
  • All documents go through a review and approval flow which creates the document baseline for SimplerQMS
  • When SOP’s are approved, training activities are automatically created based on employee job functions.

We recommend that a formal audit is executed by an external auditor checking for regulatory, QMS, and planned project activity completeness.
The project is closed when planned project activities are completed and no critical issues are unsolved.

The Implementation Process

Validated & Certified eQMS

SimplerQMS supports the administration of electronic records and signatures in compliance with FDA 21 CFR Part 11.

Our solution follows the guidelines of GAMP5, which is a Risk-Based Approach to Compliant GxP Computerized Systems.

SimplerQMS is compliant with Eudralex Annex 11. A checklist that enables the European regulatory agencies to establish the requirements for computerized systems related to pharmaceutical products and medical devices.

The software is fully validated, which requires minimal involvement from your organization. Together with our Data Center provider, we are ready for regulatory audits and inspections at any time.

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FDA 21 CFR Part 11

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FDA 21 CFR Part 820

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GAMP5

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GxP

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Eudralex Annex 11

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ISO 9001:2015

Cloud-Based eQMS

Scalable

SimplerQMS is hosted on Microsoft Azure data centers, allowing you to scale your documentation processes effortlessly.

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Secure

Encrypted data processing, SSL certification, and backups provide excellent security for your documentation.

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Valid

Fully-validated Part 11 compliant eQMS, which therefore requires minimal involvement from your organization.

Easy to Use

Familiar Windows Office interface allows performing complex tasks and gets your firm to be engaged with quality.

Featured Case Study

How Did Reapplix Move From Paper in 1 Month?

Reapplix is a regenerative medicine company that helps people who suffer from hard to heal diabetic foot ulcers, which may result in amputation. The company is in the initial commercialization phase in the US and selected European markets and was looking for a way to get rid of inefficient paper-based documentation and processes.

What People Are Saying

The collaboration with SimplerQMS has lived up to our expectations. Their service has been superb and very supportive.

Niels Erik Holm

COO, Reapplix

During the implementation of SimplerQMS, the expectations of SimplerQMS’s team have been exceeded. We have got a lot of help – also at awkward hours of the day.

Louise Flintegaard Ehlert

QA Process Manager, Cortrium