Audit Repository Center Helps Serena Software Complete Successful PDA Audits Throughout its Product Suites.

Business Editors

POTTSTOWN, Pa. & SAN MATEO, Calif.--(BUSINESS WIRE)--Feb. 4, 2004

The Audit Repository Center (ARC) (www.auditcenter.com) today announced that primary products for off-the-shelf information technology solutions for application life cycle management and application availability from Serena Software, Inc. (Nasdaq: SRNA) have successfully passed PDA audits and are now available to ARC subscribers.

"Serena, an industry-leading supplier of systems that automate change to enterprise applications, has elected to continue and expand its affiliation with ARC," said Harvey Greenawalt, ARC President. "Software companies that sell to FDA-regulated industries find the Audit Repository Center spares their customers the substantial time and cost of conducting their own audits."

The just-completed audits of Serena solutions include products from the company's ChangeMan(R), StarTool(R), and TeamTrack(R) product suites. Commenting on their decision to expand and extend with ARC, Kevin Parker, Vice President of Research & Development at Serena Software, Inc. said, " Knowing that we can obtain independent assessment of our procedures and practices measured against the PDA's Supplier Audit Process Model is vitally important to us. It allows us to be constantly vigilant in our process improvement efforts. Having that independent assessment in the ARC means our customers can be confident in Serna's commitment to Quality Software Development."

Audit Requirements

Pharmaceutical companies, medical device and clinical research organizations must demonstrate that their computer systems are validated and comply with industry regulations, such as Food and Drug Administration's (FDA) stringent 21 CFR Part 11. The audits required to demonstrate compliance are both time-consuming and costly.

Using the unique ARC approach, subscribers can save 50 percent or more on audits completed under Technical Report Number 32. They may also see an 80 percent reduction in time to obtain and evaluate audit data.

Software vendors have found that ARC provides a time efficient method to reduce cost, satisfy regulatory requirements and provide shareable data, reducing impact on development. Additionally, using ARC, software companies have seen reduced product cost to clients and a reduction of upfront cost to clients by eliminating duplication while providing continuous improvement of the audit process.

About ARC and PDA

PDA - An International Association for Pharmaceutical Science and Technology -- has teamed up with ARC to provide the industry with audits that prove good evidence of the structural integrity of computer products and services used by the regulated industry. PDA Technical Report #32 (TR-32) "Auditing of suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations" (PDA Process) is designed to provide pharmaceutical and biotech companies with the maximum benefit of that verification using a global industry-endorsed program." Pharmaceutical industry members now - at significantly reduced cost - can obtain this data for the computer services and products they use. The PDA Process repository administrated by ARC for PDA provides the means to share data collected in accordance with PDA Technical Report #32 between and among participating companies.

The Audit Repository Center is headquartered in Pottstown, PA, 19464; phone [phone]; fax [phone]; or www.auditcenter.com.

PDA is located at 3 Bethesda Metro Center, Suite 1500, Bethesda, MD 20814; phone [phone]; fax [phone]; or www.pda.org.

About SERENA

SERENA Software, Inc. is the Enterprise Change Management (ECM) industry leader. For over twenty years Serena has focused exclusively on providing solutions that help companies automate change to the applications that run their businesses. Today its products are in use at over 3,600 customer sites - including 46 of the Fortune 50. Serena's Application Framework for Enterprises (SAFE(TM)) is the next step in ECM, providing cross-platform, cross-process and cross-organizational support across application life cycle processes. This approach helps streamline development, improve productivity and lower development costs, resulting in a highly efficient enterprise. With headquarters in San Mateo, California, Serena serves customers worldwide through local offices and an international network of distributors. www.serena.com.