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features
design
support

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Description

To ensure you are not caught off guard by a potential second wave, it’s essential to digitize your prevention protocols to align with health regulations: swiftly distribute your guidelines remotely, monitor site access, adjust to new governmental directives, and streamline your reception processes. This approach not only saves time but also allows your team to focus on more critical tasks by automating Covid-related prevention processes and operational activities. The installation is quick, and management becomes simpler, enabling seamless unification of both reception and re-reception workflows, including registrations and follow-ups. With guaranteed traceability, you can enhance your tracking of contact cases while meeting regulatory obligations. Security measures are heightened as you customize your messaging for different audiences, such as employees and external partners, across various locations. Additionally, fostering awareness, conducting training, and instilling preventive measures are vital steps beyond mere compliance, especially in an environment filled with heightened apprehension, ensuring the sustained success of your operations. Overall, embracing digital solutions not only addresses immediate health concerns but also fortifies your organizational resilience.

Description

Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

$600 per year
Free Trial Yes 
Free Version Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) Yes 
Online Support No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Cikaba

Founded

2016

Country

France

Website

cikaba.com

Vendor Details

Company Name

Sierra Labs

Country

United States

Website

www.sierralabs.com/quality-management/

Product Features

CAPA

Audit Management Yes 
CAPA Planning No 
Change Management Yes 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

EHS Management

Audit Management Yes 
Corrective / Preventive Actions Yes 
Environmental Management No 
Environmental Risk Assessment No 
Forms Management No 
Incident Management No 
Industrial Safety Management Yes 
Injury Reporting No 
Inspection Management No 
MSDS No 
OSHA Recordkeeping Yes 
Occupational Health Management Yes 
Safety Risk Assessment No 
Training Management Yes 
Waste Management No 

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management No 
Corrective Actions (CAPA) Yes 
Dashboard No 
Exceptions Management No 
IT Risk Management Yes 
Internal Controls Management No 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management No 
Response Management No 
Risk Assessment No 

Safety Management

Audit Management No 
Corrective / Preventive Actions Yes 
Incident Management No 
Injury Reporting No 
Inspection Management No 
OSHA Recordkeeping No 
Safety Risk Assessment No 
Training Management Yes 

Product Features

CAPA

Audit Management Yes 
CAPA Planning No 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing No 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance Yes 
Risk Management No 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback Yes 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management No 
Periodic Review Yes 
Version Control Yes 

Document Version Control

Access Controls/Permissions Yes 
Approval Process Control Yes 
Archiving & Retention Yes 
Audit Trail Yes 
Commenting / Notes Yes 
Document Check-in / Check-out Yes 
For Engineering Documents Yes 
Revision History Yes 
Version Comparison Yes 
Version Rollback Yes 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control No 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Risk Management

Alerts/Notifications Yes 
Auditing No 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard No 
Exceptions Management Yes 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management No 
Mobile Access Yes 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management No 
Response Management Yes 
Risk Assessment Yes 

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