ShakeSpeare® QMS quality compliance software

Software for digital quality management systems, compliance, risk management and auditing

Features:

Modern work:

Replaces the go-to Excel table management in Quality and Complaince field with an professional enterprise software solution with revision trail.

Increase quality and compliance – reduce risks:

Quality and compliance software provides a structured way of working in the entire organization which follow the valid rules of the quality organization.

Constant improvement:

When processes are improved or new requirements are required it is easy to adapt the digital workflows throughout the organization.

Auditing with a central overview

Data and documents are stored in the central database, easy to review and manage, always ready for use for audits and reporting.

Fields of use

The quality management and compliance management software with the optional auditing module serves as a central QMS/RM solution in various organizations for central management and execution of all quality, compliance and risk-management processes in the company. ShakeSpeare® QMS is mostly commonly used in organizations for the digital management of the following key processes.

QMS, RM, Compliance und Auditierende Systeme

ISO 9001:2015

Context of the organization

to identify the context of the organization information is collected from various stakeholders in the company to generate the context of the organization document for ISO9001:2015 purposes.

Quality goals:

the quality goals for the organization processes are defined throughout the organization and KPIs are defined. In a later stage a review and tracking process of goals and KPIs can ensue.

Quality Policy:

Quality Policy is centrally management through the ShakeSpeare platform and can be updated, saved and versioned as well as changes tracked (revision-trail). The policy can be published within the organization and allow for the latest valid version to be accessible for all stakeholders.

Description of processes:

together with the process owners the processes are described and validated within a digital workflows. Continuous improvement and documentation are continuing through the individual workflow lifecycle for each company process.

Management of risks and opportunities:

opportunities and risks are centrally documented in one system, evaluated and tracked by relevant stakeholders.

Personnel management:

the entire application and employment process, including the on-boarding and off-boarding as well as career development process is defined per job position and managed for each individual employee in the organization.

Non-conformity management:

the non-conformities are reported by an internal auditor (or another source in or outside the organization), documented, evaluated and audited. Measures are defined and managed through the platform and progress for clearing the non-conformity tracked.

Supplier evaluation, audit and risk management:

the suppliers and partners are regularly evaluated based on defined criteria.

Internal audits:

quality system auditing is performed with ShakeSpeare with definition of the audit program, audit plan and following the results of audits by storing documents and relevant data which provides the basis for non-conformity management and control of undertaken measures.

Other common uses of the QMS and compliance software solution are:

Tracking and control of measures:

industry dependent various processes are implemented how measures for managing quality and compliance are tracked and controlled, common uses cases are in manufacturing, healthcare and finance.

Whistleblowing platform:

in accordance with the new whistleblower regulation there are several ways on how an organization should provide channels for whistleblowing to its employees and partners. ShakeSpeare provides a digital channel for an anonymous or named whistleblowing that is deployed in an efficient digital way. All process can be streamlined internally, evaluated, escalated and equipped with appropriate measures.

Control of incoming goods:

to monitor and improve the quality of incoming materials the materials are subject to goods/materials inspections. This is performed regularly, digitally documented and if necessary tagged with appropriate measures.

Accident, incident and near-miss management:

whenever an incident or accident occurs in the organization this can be recorded, documented and appropriate measures can be planned for future operations.

CE- Marking:

in manufacturing the manufacturing lines and equipment need to be CE marked and validated. When undertaking changes and modifications in the manufacturing lines a CE marking and evaluation must be performed in order to ensure safe and compliant operation.

Audit Workflows (Auditing):

ShakeSpeare QMS is used in auditing processes (either by use of tablet in the field) that involve the auditors, audited organizations and other stakeholders. An Auditing workflow is defined per standard/regulation and use-case. For that ShakeSpeare is used with government inspection institutions as well as auditing / certification companies.

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References

Software for quality and compliance management

has existed almost from the start of modern structured quality and compliance regulation, processed and systems in organizations were implemented. With the rise of the “International organization for standardization” and the global acceptance of the ISO 9001 standard in organizations world-wide as well as the ever increasing modern globalization, the requirements of the economy have changed. From global applicable regulation as well as international standards, market and customer requirements the need for organizational processes to comply has increased greatly. The purpose of such is to achieve the ever increasing quality and performance needs to remain competitive and compliance in the international markets. This has also changed the needs regarding the quality, compliance and auditing solutions from the basic requirements for document management, knowledge databases to modern quality and compliance management systems as we know them today.

Quality management software development

has often been taken on by global companies as an internal project or solved with whatever available tools and solutions that were already in place. The need to meet the requirements for compliance and risk management in international business with long and complex supply chains as well as the introduction of digital documents, workflows and processes adhering to standards that are regulating and standardizing many industries and businesses today.

With the ShakeSpeare® QMS – Quality management Software organizations benefit much more than just reducing the costs of the in-house solution development. The ShakeSpeare® QMS solution allows for a fast go-live as well as on boarding of employees in an organization through a market-proven and stable technical solution thus reducing the common risks taken on by in-house software development: runaway costs, no in-house professional knowledge on software development and implementation, dependency on key IT employees know-how, poor documentation of in-house solutions and legacy dependencies preventing such solutions to keep track with modern times and operations. No matter how far from the Head office or the compliance department, modern technology allows organizations to be more efficient in process management, tracking and take an active approach to risk and compliance management. The provisions that are important to solve non-compliance issues can be tracked and distributed throughout the global organization as well as controlled and managed in an efficient way. A very important point is also automated escalation to HQ or QMS/Compliance department if claims and non-conformity management processes get stuck in some stage.

Modern software solutions for quality management

support and automate the document generation, auditing, document publishing as well as process configuration in the software itself to digital and evaluate the company processes.

In our opinion the compliance field is one of the most extensive where the need to custom-fit solutions is rising and will remain so in the coming years and maybe even decades. The implementation of our software supports QM and RM managers as well as auditing organizations such as Bureau Veritas and even government organizations in various countries.

Modern-age companies need to make sure that they are always a step ahead of the competition. One of many important parts of that strategy is also a modern quality and compliance software solution that allows to identify and manage weak spots in the process landscape. Quality managers need modern tools to implement a quality management organization globally and gather the information to understand the organizations processes on a global level. If there are issues in the supply chains the relevant information needs to be gathered in an effective and centralized way. The quality manager needs to know when, where and how the problems are occurring in order to be able to quickly implement corrective measures in order to minimize risks. These measures need to be tracked and documented. All of that is impossible to do without proper software to support unless many new resources are added to the quality organization.

With the ShakeSpeare® technology we support various use-cases in the fields of quality, compliance, auditing and risk management for different industries and purposes – manufacturing, service industry, governments, research and innovation as well as academic organizations, healthcare, financial industry and government agencies.

ShakeSpeare® QMS / Auditing System

can be implemented with an integration in the workflow itself to government clouds, core-banking systems, patient data or clinical information systems and allows for a clear overview in larger organizations, companies and governments. The implementation is often a multi-stage project with agile project management or sometimes also as a waterfall project in which ShakeSpeare® becomes an integral part of a complex IT/IS landscape in an organization.

Independent from the field of business or activities, the value-add of the ShakeSpeare technology in QMS/RM/Compliance or auditing is substantial. We allow for deployment of customized solutions to support processes and process flows and all that with a comparatively low engagement in terms of resources needs that it is almost unbelievable that an organization can receive an adapted solution to their processes in such a short period of time.

Contact us and ask about various use-cases we implemented often or discuss your specifics that you need support with. We will be happy to present to you our technology and implementation approach with a brief presentation of best practices in our experience.

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