Dream Report is designed for 21 CFR Part 11 applications in Life Sciences, Pharmaceutical and Biotech markets.
The need for quality is paramount when you’re dealing with products essential to the health and well being of people. Today, 21 CFR Part 11 is critical to that endeavor. The FDA, Food and Drug Administration was founded back in 1906 to protect and promote public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio-pharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Title 21 CFR Part 11 (21CFRPart11) is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.
Dream Report offers 21 CFR Part 11 Features
No product is compliant or delivers compliance. At best, products deliver the features to enable the applications they are used in to be compliant, when properly configured and maintained. It is an Application, the specific use of a product for a specific purpose that must be compliant.
Dream Report Delivers the Ability to be Compliant to 21 CFR Part 11
Dream Report delivers a number of features that can be applied in order to achieve 21 CFR Part 11 compliance. These fall into several areas:
– The ability to properly secure an application from unauthorized access and to secure resulting documents from unauthorized access and tampering.
- Version Management
– The ability to document changes to an application. This is ideally offered through document version management, and an Audit Trail to capture who changes what and why.
- Electronic Signatures
– The generation of electronic documents still requires the proper review and approval cycles to become a permanent record. In the case of automation systems, electronic signatures are required to capture operator actions in running a control system. In the case of documentation products such as Dream Report, an electronic signature is applied to a document for its final review and distribution.
– The selection of the right technologies in the development of a product plays a huge role in defining if that product can support compliance, or not. A building will only be as strong as its foundation. Similarly, a software application can only be as strong as the components used with-in it, in order to be able to access your Batch Data and generate the required reports and dashboards.
To be more specific:
- Security – Dream Report delivers user authentication based on a Dream Report security model and (if your enterprise supports it), a Windows Domain Based security model. Security applies to all parts of Dream Report – Report Studio, Run-time Management Console, Electronic Signature and Web Portal. Dream Report also delivers the ability to generate secure and encrypted PDF documents.
- Version Management – Dream Report can have version management enabled, in which case it will track every new version of a report, enable users to roll forward or roll backward to any other saved version. An additional audit train will enable Dream Report to capture who changed what and why.
- Electronic Signatures – Reports can be managed through the addition of an electronic signature block. The selection that a report needs approval prior to release, and the addition of a signature block to a report ensures that reports are properly reviewed, approved or disapproved, prior to distribution.
- Technology – Dream Report is a solution purpose built to address automated report generation in the Life Sciences – Pharmaceutical and Biotech industries and to meet the special needs of 21 CFR Part 11. Dream Report is not a collection of business tools that have been gathered and squeezed together in an attempt to attain compliance. Dream Report does not use Excel as a reporting engine and is not an Excel plugin. Dream Report is not a business intelligence product like SAP’s Crystal Reports or Microsoft’s SQL Server Reporting Services ( SSRS ), being applied, through significant system integration and ongoing maintenance to achieve 21 CFR Part 11 compliance. Dream Report is designed from the ground up to meet the needs of automation industry report generation, and specifically meet the needs of FDA’s 21 CFR Part 11.
Other Requirements Common for 21CFRPart11 and Life Sciences Applications
Processing of Batch Data
Most processes in this market are run in Batch Mode, where production starts, runs and ends, making the product or component of the product that is needed. Information solutions need to be able to automatically sense a start of the process, possible phases of production and the end of the process. The result will be the ability to generate reports and dashboards at any time, by selecting a Batch ID, or automatically generating reports and dashboards based on the operation of a batch.
Life Sciences applications have requirements for record retention, often up to 5 years or more. This requires automated solutions to automatically generate directories and organize report documents by year, month, and batch IDs. In addition, it is advantageous to set bounds by date or by number of documents, so that storage systems and users are not overwhelmed by the volume of information.
While document archiving is important, delivering documents to those that need to review them is also a key benefit. Dream Report offers the ability to deliver documents via email, ftp (file transfer protocol) and drop files into Windows Directories.
Some applications require tamper-proof documents and secured documents. For this reason, Dream Report delivers PDF encryption and the ability to password lock documents while defining limitations to their use (print for example).
Interfacing with Batch Data from Distributed Data Sources
Any industrial application will have data stored in various locations. Batch data may be stored in a batch control system. Alarm data will be in an HMI/SCADA system and archived to a Historian. Quality information may be stored in a quality system. Equipment status may be stored in an asset management system. This requires an information system such as Dream Report to interface with many, potentially widely distributed system for the purpose of data access for batch reporting. With over 80 communication interfaces, Dream Report delivers the ability to access your data and generate the report and dashboard information you need for 21 CFR Part 11 and Life Sciences applications.
If automated report generation and performance dashboards are your need, and 21 CFR Part 11 is a requirement, rest assured that Dream Report is the right choice.