ife sciences organizations are under L growing pressure to reduce risk to patient, provide better quality products, squeeze time to market and comply with regulations. Too to quality and compliance. The need of the hour is to adopt a holistic approach tocompliance that is essential to achieve higher successful audits; facilitate consistency in quality processes; reduce costs associated with validation; and enable reusability of content created. The Higher regulatory compliance hurdles are making it harder for companies to bring new drugs to market. Safety issues are leading to product withdrawals and of course, genomics has also added to the deterrents of drug research and manufacturing. Further, the industry isto ensure compliance. Also, in spite of spending millions of dollars to achieve compliance, companies are often faced with issues such as: a Large amount of unstructured data = Multiple conflicting Standard Operating Procedures (SOP) = Delayed decision making due to inefficient underlying processes = Lack of management oversight = Operation overheads caused due to multiple vendors supporting multiple business processes a Value chain complexity. Companies often have procedural SOPs to take care of the greater percentage of business processes, but there is no system in place to ensure people complying with processes defined in those hundreds of SOPs. Today, companies‘QAnot involved at the beginning of | * Too many SOPs and no metric to validation, measure its effectiveness Violation of SOPs and deviation Roferences to nor-existent process, documents Inadequate training Unsigned critical deliverables Lack of consistency across sites Inability to locate documentation Inadequate training on good ‘Absence of log books for recording document practices: Seviations Inconsistent compliance requirements for standard components such as security and 21 CFRPart 11 Codes, test scripts and test ‘execution for standard requirements are not reused Testing standards are either non= existent or no followed (risk and criticality) Table I: Issues Created due to lack of Automated Control — Source: Infosys Research and Intervention Life Sciences System Development Life Cycle Table 3: Standards addressing Life Sciences System — Source: Infosys Research Development Requirements is an important issue. One survey estimates that business-technology professionals in the industry are spending up to 22 percent of their work-week, complying with regulationsFurther, most of the documents created for compliance are redundant in nature. More than a third of compliance document content is used repeatedly. Yet authors in most organizations re-create it for every document. When authors re-create content that already exists, their unnecessary effort increases labor costs and produces inconsistencies that decrease accuracy and reader comprehension. Unique Close Variation Exact Match First Time Content Figure 2: Analysis of GXP Document Compesition by ParagraphCOMPLIANCE ARCHITECTURE Using the sight compliance architecture, companies should start thinking of optimal business models that will enablea single platform for managing regulatory compliance. This can be achieved by automating compliance processes and bringing in accountability of relevant people, process and technology compliance to business functions. Such a model will help life science This architecture identifies a « framework that includes: m Process Architecture: Includes « processes in the company and d the respective scope, objective, a: roles and responsibilities = Repeatable Implementation Ay Identify all the business proces are implemented repeatedly thr the company and come up wi (templates, code repositories, au scripts, etc) that can enable 1 usage of these processes in a qt cost effective manner = Knowledge Management: TheKnowledge Management: There is no dearth of knowledge in any company. The problem often arises when this knowledge is segregated in different wings of a company. Therefore, it is essential to consolidate the knowledge within a company by providing easily accessible and appropriate repositories for content sharing, SME analyses, Frequently Asked Questions for compliance projects, case histories, etc all the business processes and compliance regulations IT System Inventory: A module that will act as a repository for information xelated to all the systems within a company, including information related to compliance regulations associated swith the systems Reusable Code: A module that will act as a sepository for all the custom built proprietary code within a company, thereby providing means for reusing the code for future projects Reusable Scripts: A module that will provide a xepository for all the test scxipts utilized during compliance testing, These test scripts may be converted into templates for zeutilization in future projects or may be simply used as references for similar testing processes in future. Effective utilization of these businessPhysician Decides to Prescnbe Medication Logs Into a Hand-held Device Opens the Patient's Electronic Record Checks for Drug Reactions or Patient Allergies Checks Formulary Status & Patient's Health Plan Selects The Strength, Dosage, & Number of Refills Selects a Pharmacy from the List and Presses Send Pharmacy Receives the Rx Via E-mail or Fax Pharmacy Picks Up the Rx, Keeps it Ready Figure 1: Prescription Process Flow