Simple and Easy eQMS Solution

for

Bio-Med Companies

Comply with ISO and FDA Regulation, 21 CFR Part 11, 21 CFR 820, 21 CFR 210/211

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1-800-921-7505

QUALITY

MANAGEMENT SYSTEM

WITH FULLY PACKED POWERFUL SOLOUTIONS

DOCUMENT MANAGEMENT: Easy document management solution. Change control with few clicks. Designated virtual cabinets. Only the released and approved documents

are available for the users.

CALIBRATION & PM MANAGEMENT: With full features for calibration and PM tracking, review and approval. Control and manage the

OOT (out of tolerance) conditions...

TRAINING RECORD MANAGEMENT: Assignment and tracking of training. Evaluation of competency requirements. Run reports and metrics...

CAPA, NCMR, SCAR : Create and manage CAPA, NCMR, SCAR records. Automated workflow with Inbox capability. Run reports and metrics.

AUDIT MANAGEMENT: Create audit plans and schedules, Execute audits and publish audit reports. Esign and automated work flow. Easy compliance with ISO and FDA

QUALCY

BENEFITS

Get More Work Done and Make Compliance Easy!

Make only the current documents are available for the users. Review and approve the changes. Search and access the documents efficiently and effectively. Comply with ISO standards, FDA Regulations (21CFR part 820 for medical devices)

Followings are key benefits of our solution.

Only the current documents are available for the users

Users search and access the documents efficiently and effectively

We always stand by our commitment of 100% customer satisfaction.

ADDITIONAL

FEATURES

User friendly- easy to use, easy to implement and configure. We have built in error proof mechanisms that prevents errors from happening during the use of the system

The system has role based identification and log in and access control, which is very secured and convenient for use. Tasks or project will not wait for someone on a vacation…

Automated Workflow inbox capabilities provide easy visibility of notifications, tasks, and records at a single place. You only see your tasks and notifications.

Full Validation Package for the Software, including URS(user requirement specification), SRS(System Requirement Specification), Trace Matrix, IQ & OQ Reports. Fully compliant with 21 CFR Part 11 requirements.

The System has E-signature capability that is auditable and traceable

Pdf printing capability with time stamps, and individual traceability

ADDITIONAL

SERVICES

Personal account manager

Online and Onsite Training

Free consultation services

Option for premium services (paid option)

OUR

GUARNTEES

Complaince to 21 CFR part11

Compliance to ISO 9001 and ISO 13485

180 days money back policy

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Company HQ Address:
5755 Oberlin Dr, Suite 301 San Diego,
CA 92121, USA

OUR

TESTIMONIALS

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Comply with ISO standards and FDA Regulations (21CFR part 820, 210, 211)for Medical Devices and Pharma Companies.

Be notified, when something is coming due. You will be able to see and plan for the Audits, Corrective Actions, Training Assignments, Calibration and PM works ahead of time.

Have easy visibility of the metrics and reports. It helps you take actions before they are too late. You can also see how many tasks are coming due and how many have gone over due.

Easy to set up and easy to use. Control access for your users, set up designated approvers to ensure quality of records and achieve compliance.

Qualcy EQMS has helped us implement a fully automated QMS. We have been using Qualcy Document Control, Audits, CAPA, Equipment Calibration and PM Solutions for more than 2 years. The change control has been much easier to manage now. The recent compliance audits have gone very well. Our employees love the application. I would be happy to recommend.

Margie Becker

Sr. Manager, Quality & Regulatory Compliance

Phoenix Flow Systems Inc.

Sample list of companies who have believed in our solutions