I am converting a completely paper based system for all internal and externals labs within my organization. This program will become a one-stop shop for all the compliance needs on these labs and will make everything effortless in creating and tracking records for all aspects of Quality.

The software is very intuitive. It is set up in the same fashion as a paper based system making the logic of the program very easy to follow.

The document management section of the software takes a long time to set up and get established. The outcome is very much worth the effort.

Sanjay was a huge help in getting us setup and modifying the modules to fit our organization. It is very easy to maintain once you get all your modules set up.

Support for this product to implement and do system changes to fit our organization was amazing. Weekly zoom calls helped a lot. Made implementing and maintain the system very easy.

With Document Management would have preferred the approval process be done with this instead of having to do a CCR.

The software was easy to set up, easy to use, and the support is readily available when needed. We are working through a few issues, but no deal breakers and I would recommend this software to other medical device companies as long as the risk management is updated for compliance.

Document Control is easy to implement and easy to use. Very intuitive with a Draft Cabinet, Release Cabinet, Change Control etc.

We are working on the Risk Management to comply with 14971. Also templates took a little longer to learn and implement for requirements. More templates also need to be added for forms.

Robust compliance features for part11 compliance. Easy to use. Very good technical support.

The built-in E-Signature and Part11 compliance are very strong. Very easy to access the audit trails and change histories. This Qualcy CAL/PM Software is user friendly. The navigation is simple and intuitive. The technical support is top notch with strong knowledge base in Bio-Pharma areas. They provided the complete validation package that including IQ, OQ reports. The Qualcy support team helped us complete our PQ requirements, and helped us migrate the legacy data into the new application.

Initially the application set-ups and user registrations were challenging. It took us some time to learn the administrative features. The customer support was always available, ready to help.

Qualcy EQMS has been help managing the day-to-day QMS functions. Saves lot of time. Has helped us reduce the errors.

Qualcy eQMS is easy to use with intuitive pages and builtin templates. Easy to search the records from the home page of the each modules. Also export option to Excel makes it life much simpler. Handling the audits have been much easier. The closed records are always in compliance status. No more stress out to find the records or show the records during the audits.

Initial implementation took longer than what we had expected. It was worth the effort. Qualcy Support team helped us move our existing data and documents to the new system. Qualcy provided full validation report for the software, this alone saved us months of efforts.

Qualcy eQMS modules are easy to use and intuitive in terms of the workflows and accessibility for the documents and records. The options for electronic signatures and advanced reminders have helped a lot. Overall, it has made our lives easier.

Qualcy eQMS is a cloud based solution with pick and choose options from multiple modules. The software provides lot more value than we could have developed inhouse solution. The software includes lot of flexibility and configuration options, that we used to customize the solution to meet our requirements. The software was provided to us with full validation reports out of the box. The support team has accepted and rolled out many of our suggestions for improvements.

Overall, it has made our lives easier, it took little longer than expected to get started with system. It took us some time to understand the role permissions and access controls for the users.

Overall smooth on-boarding and transition. Training was very effective and helpful.

The Qualcy software is flexible and configurable. The supplier of this software provided IQ, OQ validation reports which saved us a lot of time. The software complies with 21 CFR Part11 requirements. It has been very helpful for audits and compliance requirements. The software also provides option for managing PM and OOT records. This makes it easy to manage our equipment and our audit needs. Overall, satisfied with the product and account manager's support.

It was somewhat expensive compared to other products we looked at. After using the software for over a year, I think the software has paid back it's worth.

We had lot of existing equipment data that was migrated using an Excel upload option. It was very helpful. No manual data entry was required. It saved us lot of headache. This system is simple and easy to use. It is very easy to find the information when needed. It has been very helpful to manage the CAL, PM, OOT records for equipments that we use in the labs and manufacturing area. The reporting functionality provides quick view of the metrics for coming due records and overdue records. The reminders and notifications have been very helpful.

So far it has been very helpful. Not seen any issues. The system has lot of functionalities. We are planning to use the bar code labeling and scanning options.

Overall very satisfied. It is a good program.

The Qualcy CAL/PM application is highly flexible. It was easy for us to change the labels, which made the user happy, as they could use the same wordings and terminologies for internal communications. Also, the application provides option for adding additional Approvers to the records on as needed besides the minimum required approval. Also provides attachment options to attach the external certificates and documents. The workflow is simple and easy. Very nice documentation for compliance purpose.

Expensive compared to other options we looked at. The cost included validation package, training support and data migration. I think it is well worth it.

Easy to integrate and use on day one rolling it out

Not sure there is anything that I can think of I didn’t like about it.

Their team is fully compliant with 21 CFR part 11, complete with thorough audit trails and signature capabilities. The workflow management is intuitive and efficient, accompanied by robust document management functionalities. The customer support and training were outstanding, enhancing the overall positive experience.

Nothing, I am looking forward to a potential customer portal in the future, but so far everything is great!

Qualcy has made our calibration process smooth, stream-lined, and professional. Their software is designed to meet ISO standards, which we must follow in order to meet the demands of our clients--the top research institutes, hospitals, and biotechs across Southern California.

Intuitive Layout, Customizable Features, Dependable Customer Support

Nothing, it has exceeded my expectations

Very easy to use software for asset tracking and calibration management. Good compliance features for audit trails and Part 11 compliance.

It was easy to set up the system. It is easy to use with nice and clean user interface. The auto schedules for both calibration and PM have been very helpful. The reminders come to outlook inbox, makes it easy to track when something is coming due. The support from Qualcy team was great. We got the complete validation packet. The training support was very good. Qualcy support people are friendly and nice to work with.

The options for preventative maintenance can be improved. The attachment option for checklists are there. Built in templates would be helpful. We use lot of spare parts, tracking options for spare parts would also be helpful.

Qualcy provides a great platform for our start up company to build our Quality System in a step by step, easy to use format. The support for implementation was timely and thorough.

None.

so far i am impressed with the product's value. it allows our company to move quickly without being out of control.

Qualcy has a lot of customization options to make it fit your needs. the support team is also very responsive, allowing for fast deployment of new modules within your eQMS.

there is a distinct lack of a help menu. the team can support your needs well, but there should be a way to get quick answers on basic mechanics.

It was easy to setup and intuitive to use. Support and guidance was available immediately. Lots of features and customization to suit our needs.

It seems to be in the industry for a long time. This inherently means it looks a bit outdated. Recently released version looks much more current and up to date.

Qualcy QMS has transformed the way we manage quality within our organization. The system's powerful features, such as document control and equipment management have enabled us to centralize our quality processes and eliminate the cumbersome manual methods we were using before.

One of the standout aspects of Qualcy QMS is its superior customer support. The support team went above and beyond to ensure that we had a successful implementation. They were responsive, knowledgeable, and genuinely dedicated to addressing our inquiries. What truly impressed me was their willingness to tailor their assistance according to our unique needs.

Cons: None observed so far.