Regulated Document Management Solution – Life Sciences

Rule 21CFR Part 11 (“the Rule”) – is the regulation that was issued by the US Food and Drug Administration (FDA) in 1997. The Rule provides criteria for the acceptance of electronic records, electronic signatures and hand written signatures. The FDA issued the Rule and guidance so that electronic records could be made equivalent to paper records and applies to all industry segments regulated by the FDA. The FDA issued the Rule and guidance in response to requests from the industry. The expectation is that electronic records will be more cost effective for both the industry and FDA. Additionally, access to documentation should be faster and more productive.
Document Management A majority of regulated and non-regulated business entities utilize Microsoft Office® as the platform from which documents and records are created. The Microsoft Office platform enables businesses to easily access critical information, electronic forms, documents and spreadsheets from a shared filer server environment. Microsoft Office also simplifies document creation, editing and management. The broad set of familiar tools incorporated in Microsoft Office (Word, Excel, Outlook, etc…) helps to improve productivity and reduces the costs associated with training users. Streamline’s 21 CFR Part 11 solutions capitalize on current Microsoft Office infrastructure and source documents (regulated documents) that are based on Office applications without compromising the security and approved workflow controls necessary for 21 CFR 11 compliance. Streamline’s Regulated Document Management solution structured on and girded by the Microsoft Share Point Portal Server®, provides a validated 21 CFR Part 11 compliant electronic records management foundation that has been deployed in several pharmaceutical and medical device manufactures operations to meet the controls necessary for 21 CFR Part 11 compliance.		Solution Although Microsoft Office documents can be stored within a shared file structure and “locked down” at the server level to prevent access by unauthorized persons and can be configured to track and record modifications it is not a complete regulated document solution because it does not provide for the controls necessary document check out, modification audit trail, approval process with electronic signatures etc… Streamline’s Regulated Document Management solution developed using Microsoft’s® Share Point Portal Server provides the missing infrastructure to maintain and enforce workflow controls necessary for 21 CFR 11 compliance and adds these controls in a format which exploits the broad set of familiar tools incorporated in Microsoft Office.		How Streamline can help you? Using the Microsoft SharePoint Portal Server foundation, Streamline can design and develop a custom solution that will enable management of regulated documents more efficiently in a familiar electronic environment. Whether meeting regulatory oversight or streamlining collaboration, Talk to Streamline about how you can transform Information into Impact. Get teams, partners, organizations, and customers on the same page, enabling them to work together with speed and agility Provide more people within the organization better visibility into information so they can gain deeper insights, make better decisions, and take more effective action faster