Waters Completes Pharmaceutical Industry PDA Audit, Joins Audit Repository Center
Waters has successfully completed the PDA Pharmaceutical Industry Software Supplier Quality Audit. Conducted by independent, PDA-approved auditors, this evaluation allows Waters customers to meet the federal government requirements for companies that supply software solutions to the pharmaceutical industry. Following the PDA audit process, the auditors reviewed documented evidence of structural validation and assessed Waters compliance to the established Software Development Life Cycle (SDLC).
The results of Waters audit are available through the Audit Repository Center (ARC), a global information sharing venue licensed by the PDA. The PDA, a non-profit international association for pharmaceutical sciences and technology, created a six-step process for audit execution that is outlined in its Technical Report #32. This technical report was written by the PDA Supplier Auditing and Qualification Task Group — comprised of pharmaceutical companies, suppliers, auditors and FDA members — in response to an FDA challenge to create a standard method to assess the structural integrity of acquired software.
Pharmaceutical companies must demonstrate compliance with industry regulations, such as the Food and Drug Administration’s 21 CFT Part 211.86 and 21 CFR Part 11. It is both costly and time consuming to show compliance with the audit requirements. By making the results of Waters software audit available through ARC (www.auditcenter.com), Waters customers do not need to conduct their own on-site audits, saving significant time and money.
“Waters is pleased to offer a solution to enable our customers in the pharmaceutical industry to be more efficient in their evaluation and deployment process,” said Noor Malki, Regularly Affairs Manager at Waters. “The ARC audit process significantly reduces the audit burden on our customers.”
Waters audit report contains more than 110 pages of information detailing the objective evidence that was examined during the audit. The complete report is placed on a CD-Rom that can be mailed out to Waters customers, upon request and only through the ARC, within days. Highlighting Waters successful audit completion are the words of an audit veteran. “Waters received the highest marks of any company that I have audited in 20 years,” commented Phil Lofty, lead auditor of Watson Pharmaceutical and PDA-certified auditor.