Qualtrax Compliance Software

Corrective and Preventative Actions are the backbone of an effective quality management program. Without an effective system for documentation, timely response and reaction and subsequent preventative programs implemented, the result can be very costly. The problem most companies have is not documenting the corrective actions but being able to provide a timely response through resolution, demonstrating an audit trail of actions taken and assigning a responsible authority for each step of the workflow.

Problem: Joy is currently trying to keep up with four different CAPAs from various departments within the company. Each CAPA is in a different phase of completion. Keeping track of progress and communicating progress to the necessary parties is a time drain.

Solution: Joy gets each CAPA started electronically in Qualtrax. Joy can set up daily reports to come directly to her email to track each CAPA’s progress. The different steps are routed from person to person electronically with automatic email reminders, so Joy s day is suddenly open again and she no longer needs to spend her time worrying about each CAPA’s progress. The information she needs comes directly to her inbox.

Maintaining compliance is not an easy project to handle manually. There are lots of organizations that are using shared network drives to manage documentation, and in a lot of cases, paper systems to manage accreditation. These types of systems can be hard to manage, navigate, and are very prone to error, lost documentation, and incomplete standards management. Many organizations are understaffed or have limited resources, so managing accreditation consumes at least one full-time resource, especially around audit-time.

Problem: Jennie knows that an external audit is about to occur, so several weeks in advance she starts putting in extra hours to make sure they have all the documentation they need in order to satisfy the standards. Jennie has to dig through electronic files to makes sure she's go the most recent versions of documents. When a document is out of date, she has to track down the correct person in the facility to update the documentation and approve its accuracy. Jennie also has to dig through files and binders to make sure all customer complaints are in order and documented correctly. Finally, Jennie has to pull all of this information together for the auditor to have access to.

Solution: Using Qualtrax, the entire company now works together to make sure all information around compliance is associated to the appropriate part of a standard within the system. Now that all documents are being controlled in Qualtrax, everyone can rest assured that the most recent version of a document is available to everyone at all times. Also, all internal processes are now being tracked in Qualtrax, so it takes a matter of minutes to pull up past customer complaints, nonconformance reports, calibration reports, and more when it's audit time. Jennie can run a quick report to see where gaps in compliance documentation exist, and fix those issues before the auditor ever arrives! When that auditor comes to the facility, Jennie just gives the auditor access to Qualtrax and the auditor can easily see the documentation needed to complete the audit—documentation that doesn't pertain to an audit can be given a permission setting so only company personnel can see it. This facility has full control over the audit and successful compliance to any standard!

Preparing for audits can take hours upon hours of manual labor for many different employees. Then, when the audit is complete, you may have hours and hours of re-work to do in order to satisfy any non-conformances found. Everyone would agree that being audit-ready all of the time is the best way to operate whether the audit is internal or external. A successful audit is a result of keeping all the information you need up to date and accessible at all times.

Problem: Jamie spends countless hours trying to stay audit-ready. Keeping employee training records up to date, ensuring the newest version of standard operating procedures and other key documentation is given to employees, managing each part of every standard, and documenting company processes and procedures is a lot of work for one person or department – especially when audit readiness is a company-wide ordeal.

Solution: Jamie can go in to Qualtrax and make sure all of the information needed for a successful audit is up to date by simply using different reports. Employee records are kept electronically, only the most current documentation is available to employees, gaps in compliance can easily be found, and all company processes are electronically routed. All the information you need for a successful audit is right at your (and your auditor’s) fingertips. Suddenly, audit-readiness is a matter of clicks, not hours.

Your company has a tremendous amount of documentation to keep up with. In a paper-environment, document retention takes up an enormous amount of space—even if you're using a network drive to store your documents electronically, there are so many revisions to store that it's easy for that drive to get ugly and unmanageable, fast! When you're retaining documents for several years, this quickly adds up. Now, tracking the history of all of these documents is a big task to wrap your arms around but is a requirement for your company.

Problem: Amy is looking through files on her company's network to try to find the most recent revision of her facility's Customer Complaint policy. There are several versions of the policy, and she needs to make sure that she pulls the most recent version for the auditor to review. If it's this hard for her to locate, imagine how it must be for every other employee of the company!

Solution: Using Qualtrax policies are searchable and easy to navigate to through the browse tree. Amy can also see all of the past revisions of the document in the event that she needs to go back through and see when the document was last updated, who it was updated by, and what changes were made. This is true of every document in the system!

You handle a lot of very sensitive information that visitors and auditors don't need to see, but that you definitely need to have record of in your system. Every single document you put in Qualtrax can be given specific view and edit permissions. This allows your company complete control over who can see and edit your documentation. This also eliminates the need to have confidential information sitting on a shared drive or in a binder/filing cabinet.

Problem: Brad is a manager who wants to make sure that certain documents are only viewable by a specific group of employees in the company. In a paper system this means that a handful of employees are given security privileges to certain paper documents, and in an electronic environment these employees need to have access to certain folders on the network. Now, the trick is making sure that these sensitive documents only appear in these limited locations. In addition, as employees come and go at the company, Brad has to keep these permissions current.

Solution: Using Qualtrax, Brad can set up groups in the system and give them specific permissions to view and edit specific documents. This guarantees that only employees with certain security permissions can access sensitive documents. As users are added or deleted from the system and put into groups in Qualtrax, these permissions will automatically be granted to the appropriate employees. Brad can rest easy knowing that sensitive documents have the security they need. Using Qualtrax permission settings is also a great way to ensure that all employees see documents that pertain to their job function, and this helps you limit what "view-only" guests (such as auditors) are able to access when they visit your facility.

Every business (yours included) has several processes that require paper passing. Equipment calibration, purchasing requests, paid time off requests, customer complaints, and others are all processes that can get lost on someone's desk or email inbox. It's a waste of everyone's time to try to track down the next person in line to ensure a process is pushed through to completion, and it can be very time intensive to determine status of a process. Processes are a reality for every business, and handling them isn't always easy.

Problem: Gary is trying to put in a vacation request for his summer trip. He's filled out the paper form with plenty of time to spare and given it to his manager. Gary's manager has taken the vacation request and signed off that it's been approved. This request now needs to be sent to the HR manager, but the vacation request gets lost on Gary's manager's desk once things in the police department pick up and more strain is put on the manager's time. The vacation request finally turns up, but only after Gary checked in with his manager to make sure everything was in order for him to leave town the next week.

Solution: Gary logs in to Qualtrax and submits his vacation request using a Qualtrax workflow. This request will route directly to Gary's manager where he'll get an electronic notification that approval is needed. Once Gary's manager has approved, the vacation request will be sent to the HR manager who will give final approval. At that time, Gary will get an electronic notification saying that his vacation has been approved and he's good to go! In some cases, customers will have approvals put a notification on a company-wide calendar, and alert Gary's close employees that he'll be out. While this process is going on, Gary can log in to Qualtrax at any time and see where his request is in the approval process - this gives everyone visibility of what is going on and peace of mind that things are going as they should.

Trainings and certifications (and re-certifications, for that matter) are one of those things that somehow takes up more time than we'd all like them to. In a paper-system, pulling files is a long, hard way to make sure your whole organization is up to date on trainings, and it's easy to overlook re-certification and training deadlines. Qualtrax will help you keep everything in line by notifying managers when trainings have expired, and when re-certifications are in order. All trainings can easily be reported on so that you can see where gaps in training requirements might exist.

Problem: Drew knows that he has met his standard training requirements, but isn't sure when one of his re-certification trainings is due. He goes to his manager to ask them to pull his training records so he can plan his training accordingly. His manager (who is juggling several tasks) gets to it as soon as he can. Finally, they pull his record only to find that he has two incomplete trainings that should have been completed the month prior.

Solution: Using the Qualtrax training matrix, Drew logs in to Qualtrax and pulls up his training history. He can see all of the trainings that are available to him and whether or not they are required or optional. From here Drew can also see which trainings have been completed and which trainings still need to be satisfied. Using document management, Drew can also see when his certifications expire. Drew's manager can also use the training management piece of Qualtrax to quickly run a report to see who has completed necessary trainings and where employees still need some training.