QMSuite® is a modular set of core Quality Management Functions, providing the most cost effective way to implement your Quality Management System. We can assist you in getting your Quality Unit the tools that they need, when they need them. You don’t need to be an IT or Regulatory Compliance expert to start using QMSuite®.
We can help you navigate the regulatory requirements for company
and allow you to focus on the things that matter most, while reducing the cost
and resource burden that normally accompanies any system implementation.
Based on the Microsoft SharePoint® 2016 platform, QMSuite®
provides companies with the ability to quickly and inexpensively implement and
manage required quality records while seamlessly integrating with all of your
Microsoft Office® products, enabling compliance and productivity.
It's easy to get your organization in compliance quickly with DCS On-line Quality Management Modules. Proven Processes are at the heart of each solution, incorporating experienced People and process enabling Technology to bring your quality system solution online quickly.
Each quality system module provides GMP compliant functions immediately. As needed, it can be configured to fit your company's unique needs. Your system is securely maintained at our SSAE-16 compliant data center.
User access information from your corporate directory can be integrated with the DCS systems, allowing only your staff to seamlessly operate from both inside your corporate network as well as securely over the Internet.
Always up to Date: QMSuite® modules are constantly maintained. Upgrades to the most current versions of Hardware and Software included at no extra cost. Notifications: E-mail alerts to assure timely responses to quality & compliance related tasks. Single Sign-On: Directory trust with your Microsoft Active Directory®, providing pass-through authentication. Highly scalable: Serves companies large and small; Subscriptions scale up or down to fit any size business, allowing rapid and cost effective solutions. No Internal Footprint Dedicated servers, network equipment, and physical space is all located in DCS data centers, providing you with logical and physical security at 99.999% up time.
Dynamic Compliance Solutions offers a comprehensive set of quality system solutions to support your organization’s compliance with regulatory agency requirements for a simple per-service monthly fee. Our basic Quality System components include:
Document Management with online collaboration, version control, review and approval workflows, and electronic signatures to manage life cycle of your controlled documents.
Doc-Links™ helps your organization manage the entire lifecycle for all of your controlled documentation. This module supports typical document lifecycle functionality such as; Document Change Request (DCR) management, Collaborative Reviews using tasks and email notification, maintenance of all edited versions and 'checkout' of documents for offline editing.
Workflow functionality is built-in to allow users to route documents for review and approval. Configurable templates and metadata allow your organization to establish purpose built documents that include only pertinent information related to specific document types. (i.e. Policies, SOP's, Work Instructions, Specifications, Test Methods, etc...).
Our document management templates can be configured to include all the unique aspects of your organization.
A Secure Records Archive with check out capability for controlled documents such as Policies, Procedures, Work Instructions. Provides simple and secure access to many other critical records. In coordination with Doc-Links™ this module enables the use of only the most current approved documents to assure compliance.
Arch-Links™ helps your organization manage all of your controlled documents and records. This module enables secure sharing of critical documents within the appropriate groups in your organization. Supplier generated records can be securely stored and easily shared within the organization. Stored with additional descriptive information (metadata), these records are easily retrievable.
Security & Compliance
All DCS SAAS hosted servers are held in an SSAE-16 Type II compliant data center. In addition, security permission groups are configured to match separate roles in your organization as needed. This module supports 21 CFR Part11 compliant Electronic Signature and electronic approvals.
Our basic records management templates can be configured to include all the unique aspects of your organization.
Learning Management that tracks and manages compliance training:
Employees can access policies, procedures, and company training modules using any SCORM-compliant content. Managers can track compliance, view dashboards, and export reports detailing user progress and grades. Significantly reduces the time needed to create and deliver critical training.
Train-Links™ helps your organization administer all of the required training needs of your staff. This essential Quality System component uses a complete Learning lifecycle process including; course creation, role based course assignment, on-line training deployment and record keeping of all training records for each staff member. Our unique configuration permits FDA compliant electronic signatures for all courses taken on this system. We have also incorporated the ability to capture “read & understand” training records, which are essential for the integration of key procedures into your organization in the most cost effective manner possible.
Integrated workflow functionality allows the training coordinator to to assign staff members to Roles and Roles are then related to training materials. Configurable metadata enables your organization to establish Roles that include only pertinent training related to specific job types.
Our basic learning management module can be configured to include all the unique aspects of your organization.
Change Management with online forms to capture change requests. Circulate them quickly for review and approval, while never losing track of a request form.
Change-Links™ helps your organization manage Change Requests. Each Request is captured in an electronic form. This core Quality management solution enables on-line Review and Approvals of each change request. This allows all Requests to be tracked to closure.
Change-Links™ enables integration of supplier initiated Change Requests; classified & updated. Supplier Requested Changes can be attached for internal review. Team members can review Requests and Attachments on-line and incorporate changes using PDF form annotations.
Allows your staff to define and categorize Requests according to your organization’s needs and enables real-time tracking of review & approval actions. This allows the Change Coordinator to manage and retain statistics regarding all requests which is essential to timely processing and compliance.
Incident Management that provides simple recording of Deviations and CAPAs in easy to use electronic forms that align with your organizational processes to assure compliance.
Incident-Links™ helps your organization manage Deviations and Corrective & Preventive Actions (CAPAs). Each incident typically must result in an investigation, determination of Root Cause and subsequent Corrective and Preventive actions. This core Quality management function enables numerous types of incidents like Deviations, Divergence, Out of Specification (OOS), Out of Tolerance (OOT) to be logged analyzed and tracked to closure.
Incident-Links™ provides complete incident lifecycle functionality; incident identification, categorization, Investigations & updates, Action assignment, Action tracking while allowing team members to upload associated documents and track the status of related actions.
Incident-Links™ includes the ability to define and categorize incidents according to your organizations needs then enables real time tracking of trends and alerts management when investigations & actions are incomplete or overdue. This allows the incident coordinator to manage and retain statistics regarding all incidents which is essential to your annual reporting.
Our incident management module can be configured to include all the unique aspects of your organization.
Supplier Management integrates all your supplier qualification activities; Audits and critical follow up items and metrics. Re-qualification can be managed by Audit, Survey, or Questionnaire.
Supplier-Links™ helps your organization manage the logistics and status of your material supplier and service provider audits. This includes audit program management functionality, such as allowing team members to request new suppliers using the NEW supplier evaluation request, view the overall status of the audit program by visualizing upcoming, in-process and completed audits, review supplier questionnaires, audit reports and audit responses in a user friendly environment. Additional functionality enables planning and budget forecasting.
Our supplier management module can be configured to include all the unique aspects of your organization.
Record Management enables streamlined integration of incoming supplier records. Incoming records are captured in a common repository and directed to the appropriate quality system solution for further processing.
Record-Links™ Records Management enables streamlined integration of incoming supplier records. Incoming records are captured in a common repository & directed to the appropriate quality system solution for further processing.
Workflow functionality is built-in to allow users to route incoming records to the appropriate QMSuite™ module for further processing. Configurable metadata allow your organization to establish purpose repositories that include pertinent information.
Our basic Records Management module can be configured to include all the unique aspects of your organization.
Staffing and Outsourced Services: DCS is a full service partner, providing staffing options such as fully outsourced services and Temporary contractor support while you come up to speed.
Data Integrity Assessment and System Validation: DCS can provide your company with analysis and consulting services to augment your Quality and Compliance staff related to Data integrity Assessments using the latest PDA TR 80 guidelines and Agile Computer Systems Validation.
Migration: Many customers have existing quality and business platforms or older versions of software. Working with our partners, DCS can help you develop a strategy for migration, outline the risks, and facilitate migration activities that will allow your company to continue to evolve.
Integration with other Applications: DCS, along with our extensive network of partners, can integrate our applications into your existing systems.
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