Simple and Effective SOLUTIONS
Manage Calibration schedules and reports. Notifications and monitoring for past due calibrations. Create and assign work orders, track status of the work orders. Retain CAL and Maintenance records.
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)
Easy planning of audits, simplified flow for execution of audits. Tracking and follow up for the audit plans. Audit reports, Non conformances are released automatically when the reports are approved. System provides reminders for Reviewers and Task Owners.
Assignment of Training on as needed basis or automatically from the change control system. Training completion and documentation of training records . Compliance of the Training records with Regulations and Standards. System provides reminders for over due training items.
We understand that the some of our customers do not have strong knowledge base regarding the standards and regulations. We provide online and offline trainings for our customers. We provide user friendly, simple and effective software solutions. The builtin work flow and features makes it easy to comply with regulations and standards. We also provide remote work load sharing, if you ever need any extra help. We do not claim to be 100% perfect. But that is our vision.
User Friendly- Easy To Use
Our software solution includes simple and user friendly features. Easy to understand and easy do the trasactions.
We provide solutions that helps you meet the needs of your customer requirements and regulatory requirements.
Peace of Mind
•Unlimited Access • Simple 3 Tiered Pricing Options• No annual maintenance fees • No hardware to purchase • Secured and backup at Amazon AWS plattform.
Pay for what you use
• Purchase only the modules you need • Pay for additional training and support as needed.
21 CFR Part 11 Compliance for Calibration and Asset Management in Bio-Med applications- Published on 22 Aug. 2018
The computer software should be easy to use and automate manual transactions and calculations involved in the calibration/PM and asset management processes. The computer software shall comply the FDA validation and Part 11 requirements Equipment Selection and Qualification Equipment design and selection shall be appropriate for the process requirements. (Defined through the process validation) Equipment[…]
Tips and Tools for Audit Planning and Execution The followings are sub processes for a successful Audit program. Audit Planning: The success of the audit process starts with the audit planning. The followings are some of the audit planning activities. This can be used as a good checklist for the planning[…]
At Qualcy Systems we believe in the power of simplicity and ease of work flow. We combine the power of simplicity with the process approach to manage the quality system functions. We want to transform the way automations are used for managing processes for quality system. The users shall find it easy to use and[…]
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The contents and documents are at the heart of the organizational structure and Process Management. It is easy to follow and reproduce the results of the processes which are defined and documented. We cannot rely on individual memories to execute the processes. Whether it is a small enterprise with less than 10 people or larger[…]