The PA 800 plus Software includes features that allow you complete control of the PA 800 plus and P/ACE™ MDQ Systems. The software includes methods and sequence table development capability, advanced data analysis functionality, and includes the analytical tools necessary for proper integration and quantitation of data. In addition, advanced custom reporting can be done in order to output results the way you want to see them. The Direct Control capability allows for more direct user interaction with the system. Additionally, the software also allows for single point control for all detectors configured on these systems.

The PA 800 plus software quickly guides users from set-up through routine system operation. Large icons provide intuitive guidance for navigation while on-screen cues indicate system progress at a glance. Insightful Help menus and descriptive system prompts further simplify operator learning, making transfer of PA 800 plus technology to other analysts easier. Ultimately, using PA 800 plus software is as easy as 1, 2, 3.

1. Select Application	2. Load samples and     application reagents	3. Acquire Date

Click here to download the PA 800 plus Software Validation Pack.

Controls Regulatory Compliance

As the CE systems are often used in a regulated environment, the 32 Karat Software control of the instrument contains the controls necessary to enable compliance with 21 CFR part 11. Importantly, no software can be 21 CFR part 11 compliant, but rather includes technical controls that when properly used, enable compliance.

21 CFR part 11 is a set of regulations put into place as a result of the pharmaceutical industry approaching the FDA to more closely scrutinize data and data management. In order to accommodate this, use of electronic record keeping and electronic signatures was established in an effort to validate record keeping processes as being trustworthy and reliable.

21 CFR part 11 requirements can be categorized into one of three types of control. One cannot be compliant with part 11 until all three control types have been implemented.

Administrative Controls: Guidelines for 21 CFR part 11 within an organization and include a company interpretation of the regulation and how the company will verify the identity of individuals, and ensure non-repudiation of electronic signatures.

Procedure Controls: Standard operating procedures (SOPs) for a system which includes instructions on its use, a list of authorized users and access levels, as well as back up and recovery procedures.

Technical Controls: Security and access control for a given application and the audit trail to monitor changes to the records.

Click here to more information on 21 CFR part 11 compliance.

Click here for more Information on Qualification Procedures.