Complying with the API Spec Q1 standard is critical to your business. Not only does it ensure that you are adhering to legal requirements for your company's products, but it also helps ensure that what you produce meets the needs of your customers. Document management is a critical component of the quality requirements governed by the Q1 standard.
Digital innovations in compliance management has streamlined this process and made it much easier for companies to comply. These flexible, cloud-based solutions make it simpler for companies to effectively manage the processes and document them, which provide benefits beyond meeting regulatory guidelines. This documentation and digital record keeping also makes identifying flaws in production processes and resource management easier to identify and correct.
Documentation for Q1 compliance serves three critical needs:
While documentation has always been required to meet these goals, the manual nature of collecting the information was often a barrier to full and accurate documentation. In today's world, cloud-based web solutions have removed these barriers and simplified the steps required to meet the Q1 standard for both process management and documentation.
Finding the right management solution for your business is easier than it has ever been. Contact Accupoint software to find out how we can help streamline your Document and Procedure Management process.
For any business, the more efficient your business processes are, the lower your business costs will be. Identifying the appropriate corrective actions not only eliminates poor practices, it also ensures that your business is in compliance with applicable API standards.
There are many reasons why corrective actions become necessary. Those reasons can include process issues, customer complaints, or improper training among other things. Effective corrective actions should be informed by data that is gathered throughout the productions cycle. The most effective way to gather this data is through the utilization of software. Through automation, it will be easier to see process dependencies that may not be apparent if each stage and its supporting processes were looked at individually. This approach eliminates the likelihood that a corrective action in the production process has a negative impact on processes that follow it, like packaging and shipping.
Choosing comprehensive quality management software that includes data collection for corrective actions will help ensure that your micro decisions are made with considerations for the macro business environment. The software should also allow you to quickly gather information to assess the impact of corrective actions to make ongoing changes rapidly if needed. And, the software should have functionality to generate real-time reports to support recommended corrective actions to win company buy-in.
Accupoint Software empowers companies to make optimal decisions to improve productivity and drive more efficient operational procedures. For more information on how Accupoint can help you manage your corrective and preventative action programs, visit www.accupointsoftware.com or call us at 800.563.6250.
Procedures are extremely important in any business. Not only do they help tell employees how and why a task is completed in a certain manner, but they can also help show that the company is compliant in regards to regulations as well. For this reason, having proper procedure management is a must in any business.
When it comes to procedures, there are a few things that auditors will look for first. For example, auditors will look to determine if the procedure was put through the proper approval process. Also, auditors will look to see if a system is in place that can objectively review a procedure. In order for businesses to answer these questions, proper documentation must be gathered.
One of the most difficult things about procedure management is keeping track of documentation. Since there are many ways that employees can correspond with one another, there are many documents that may surface in the process of developing and maintaining a procedure.
For example, while email correspondence may be available for one procedure, physical, paper documents may be available for another. Because of this, many companies choose to rely on specific software to keep track of all the documents related to the procedure process. Through this software, auditing procedures is a much simpler process.
Software can also benefit a company because it provides the ability to store procedures in a convenient location. Not only will this help to streamline the audit process, but it will also help ensure that procedures will be completed as directed.
To learn more about Accupoint’s comprehensive procedures management and document control functionality, contact us www.accupointsoftware.com or call us toll-free at 800.563.6250 to arrange for a platform demonstration.
As a member of a thriving, successful company, it’s logical to assume you have a proactive plan prepared for emergencies or unexpected events. It’s also reasonable to assume that you have proper documentation to ensure that your team knows what to do when the unexpected happens.
API Spec Q2 issues the directive that in order to remain in compliance with the standard, service organizations must have a contingency plan in place and must have the procedure expressly documented for this purpose. The standard also states, “The procedure shall include incident and disruption prevention and mitigation measures.” So your plan must be pre-emptive and include modified processes to implement when the need arises.
Have you tested your alternate plans to ensure they’re realistic? Do the members of your organization know about the plan? The standard requires that they do as well as your suppliers and customers.
Behind every standard is a logical, practical reason for its existence. The common elements are safety, productivity, and efficiency. So, when you drill it down to those terms, why wouldn’t you want to be in compliance? Having an up-to-date contingency planning in place—and making sure everyone knows about it— is a win/win business practice for you, your team, suppliers, and customers.
Managing these contingency plans is just as important as developing them. The best way to manage these plans is to store them within a reliable and accessible system. Accupoint offers solutions that allow you to effectively manage your important documents and retrieve them on a moment’s notice.
Remember, the one certainty we can count on is change, Are you ready?
For more information on how Accupoint’s solutions can help you manage your contingency plans, visit www.accupointsoftware.com or call us at (800) 563-6250.