The Odd Couple - Quality vs. Research

Patricia Santos Serrao

Compliance is often seen as a subjective word, and at best can mean something very different from one functional area to another within the same organization. The compliance requirements for a quality group are very different from those in R&D groups such as Clinical and Regulatory Affairs. Technology and processes can play a significant role in defining and meeting compliance requirements, however if the technology is not flexible and configurable it can become difficult to implement one solution for all areas.

For example, manufacturing and research have often been referred to as the "odd couple" with manufacturing requiring stringent and repeatable processes to ensure consistency and quality, whereas research can be hindered by such restrictions as it limits one's ability to be nimble and "go with the flow" as needed. Nowhere is this truer than when an organization is looking for an enterprise document management solution. In most instances both quality and research are looking for the same basic functionality such as: document storage, access control, routing, collaboration and electronic signatures. However, the challenges come with the details of how each area (i.e, quality or research) uses those features. The table below outlines some examples of how features and functionality may be used differently across functional areas.

Feature / Function Quality / Manufacturing Research / Clinical / Regulatory
Document Control Change Control (documented reason for change) Change Control NOT needed
Training QA requires training records Training required of both internal and external study participants (i.e, CRAs, Monitors, CROs, and Investigators
Review Periods Most documents (i.e., SOPs) are scheduled for review annualy Document reviews are not always scheduled as many of the changes to information are based on issues and findings during the study or due to requests for clarification
Workflows Workflows often require multiple review, edit or approval steps, and most require signatures Writers prefer to work offline in an uncontrolled environment when drafting and only route for approval
Lifecycle States Lifecycles of QA documents include draft, approved, released, archived / superseded. Older versions are retired Lifecycles in R&D include, draft, and approved, with older versions at times being superseded
PDF Rendering Often the quality department wants to control who can print or copy/paste a document; the quality department may also want to set a time limit at which a document would expire or move to a password-protected phase. R&D Documents—particularly those submitted to the FDA—have very different security requirements from quality-related documents. For R&D documentation FDA specifically requests that ALL PDFs submitted should NOT have securities applied to them.

The ability to implement a single document management system enterprise wide depends heavily on the system's configurability. If users feel that a system does not provide the control they need in quality or is too restrictive in the R&D areas users will resist the change because it makes their day-to-day work more complex. As with any system, user acceptance is critical for a successful implementation. If you would like more information on how MasterControl is helping customers implement MasterControl Documents enterprise wide through configuration please contact your account manager.

Patricia Santos Serrao, RAC and Senior Product Manager for Pharmaceuticals at MasterControl, is a Life Sciences professional with almost two decades of experience in regulatory affairs and clinical areas of the pharmaceutical industry.

Prior to joining MasterControl, Patricia held the position of Manager, Global Regulatory Solutions for QUMAS, a company specializing in quality and compliance management software for life sciences, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the pharmaceutical industry with a particular focus on submission document management for regulatory affairs, and Clinical Trial Master Files (CTMF) for clinical.

Patricia has worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, both in regulatory affairs and clinical. She has also assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling eCTDs, and other submission format filings worldwide. A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a Bachelor's of Science degree in Business Administration. Patricia is a member of REgulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA). She has also earned her Regulatory Affiars Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB).