Whether it′s a greenfield project, a retrofit, or an upgrade, automation in the life sciences industry always has one eye on the clock and the other on the FDA. At Avid Solutions, we understand that all systems need to be safe, secure, and reliable – and they also need to be implemented as swiftly as possible. We understand that the availability and purity of your products are at stake.
When the driver for a new control system is a new product, every day until that system is implemented is a day that the product is not generating revenue – and a day that patients are not receiving the benefits of using that product. Getting up to speed means making smart choices every step of the way - from design to testing, training and implementation.
When Avid Solutions is your system integration partner, you can depend on solid experience to streamline your project and get your systems up and running smoothly. We understand how your industry works and work within all constraints for the best possible outcome.
Part 11 of Title 21 of the Code of Federal Regulations (CFR) applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any record requirements set forth in the regulations of the FDA. In the transition from paper to electronic recordkeeping, Avid Solutions can help you comply with the FDA requirements for reliable and secure records.
Electronic Batch Records
Many fear vulnerability and uncertainty along the path to electronic recordkeeping. With the in-depth knowledge and experience of the team at Avid Solutions, the move away from paper records will result in improved compliance, shorter quality review cycles, reduced product loss, and potentially decreased batch cycle times.
In the complex world of pharmaceutical and biotech companies, not all risks are equal. Avid Solutions can work with you to focus on the process steps that carry the highest risks and then design solutions to minimize those risks.