Audit regulations and compliance readiness
Many systems in the market today may not adequately ensure the appropriate preventive maintenance services and verifications to ensure that your performed activities adhere to the strict regulations of the pharmaceutical and biotechnology industries. Having the right tools in place helps you avoid the risk of failure and improves your equipment and asset reliability.Companies that struggle to maintain their equipment and documentation can suffer from being at risk every time they get audited. If you sense that you are losing your precious time with regular tasks, you need to consider employing systems and computerized tools to make your team more efficient and able to achieve all of your business goals.
So, the question to ask is, “what do I need in order to be ready for these surprise audits if I already have a computerized asset management system?”
Let’s start with the main players in this operation, the product quality officers, quality risk managers, and other qualified personnel. These valuable people are responsible for ensuring that everyone has the right set of tools to perform all activities in a compliant manner, making sure that their systems are CFR 21 part 11 complaint and that they record data accurately.
the key to success in this operation is to have an efficient system of record. One that relieves you from having to keep everything under control. Unfortunately, if you are still using a paper-based system, you are probably duplicating efforts on manual updates and follow- up. A manual approach also doesn't provide enough effective visibility and oversight to ensure equipment performance and condition or the quality of the service provided to your customers.
Here are some tips to help you choose a new system to cover all your asset management needs:
Tip #1 The system should be able to handle paperless operations, allow language localization, hold a 21 CFR Part 11 compliant electronic audit trail and signatures, have customer/vendor portals for issuance of work and viewing past work.
Tip #2 The system should be a primarily out-of-the-box solution that requires minimum configuration or internal resources to maintain.
Tip #3 The system should also have the capability to track all assets/equipment under management’s performance from service to service, allowing real-time access to performance reliability data and automated workflows reduce risk and eliminate failures.
Qualer asset management software is a fully validated cloud-based platform where you can rest assured that your assets, services, and daily tasks will live in a state of compliance without wasting your valuable time.
At Qualer, we offer our GAMP®5 Lab Management Software validation package that allows you to use the system in compliance with 21 CFR Part 11 from the minute you join.
Find peace of mind relying on our management of the IQ/OQ/PQ documentation and processes needed for system validation minimizing the compliance work, so you don’t have to.
