ACD/Labs Regulatory Compliance Statement
The pharmaceutical development field is subject to stringent data and report controls. These controls, determined and enforced by regulatory bodies such as the Food and Drug Administration (FDA), specify key aspects of software development, testing, and functionality to ensure that these systems are both reliable and trustworthy. During the past decade, ACD/Labs' track record for scientific rigor has been met with greater emphasis on regulatory controls so that our products are increasingly being used in the pharmaceutical development field. Furthermore, ACD/Labs expertise in accelerating research can help mitigate the greater cost overhead of regulatory compliance.
As an example, a small list of some of these rules from the Code of Federal Regulations, Title 21, that would be most applicable to ACD/Labs and our customers is listed below:
- CFR 21 Part 11 - Electronic records; electronic signatures
- CFR 21 Part 58 - Good laboratory practice for non-clinical laboratory studies
- CFR 21 Part 210 - Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general
- CFR 21 Part 211 - Current good manufacturing practice for finished pharmaceuticals
- CFR 21 Part 820 - Quality system regulation
- CFR 21 Part 862 - Clinical chemistry and clinical toxicology devices Subpart C - Clinical Laboratory Instruments
- CFR 21 Part 1002 - Records and reports
To this aim, ACD/Labs endeavors to produce market leading software using quality systems that support and enhance our reputation for innovation and quality. Our Enterprise Solution application components are being developed and tested with these regulatory authority controls in mind. With the release of ACD/Labs v8.0, our Spectral and Chromatographic Processing, Databasing, and Viewing technologies can be validated according to these codes.
Compliance is related to the interpretations of the company seeking validation statements. In this regard, ACD/Labs is happy to assist companies with the validation of their Enterprise Solutions. Please contact validation@acdlabs.com for more information.
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