Life Sciences
Life Sciences organizations must comply with strict regulatory requirements. Pharmaceutical, bio-tech and chemical manufacturing companies have prolonged processes that each generates records to be declared and classified – from R&D, clinical trials, FDA approval, and manufacturing to distribution stages. To further complicate things, a drug may go by different names in foreign markets, and may need to be cross-referenced by its ingredients or compounds. The integrity of the records management system, audit controls, security and storage for each remains critically important. Archive Systems specifically addresses these challenges and makes it simpler for records managers to maintain productivity while addressing regulatory compliance.
OmniRIM Records Center – Life Sciences Solution
OmniRIM Records Center is available as a pre-configured, hosted solution that allows companies in the Life Sciences sector to minimize time, effort and cost to tailor the system for their organizations, and quickly get productive in the business of managing and controlling business-critical records.
Key Features:
- Intuitive and elegant User Experience
- Dashboards
- 21 CFR Part 11 Compliance
- Tracks and indexes records by drug or chemical compound
- Pre-configured Record Types and standard Metadata for Life Sciences industry
- Designed for companies operating in geographies all over the world.
Usability
OmniRIM Records Center is designed for Life Sciences companies that manage R&D and manufacturing facilities all over the world. Great effort has been taken to ensure the user interface, navigation and other elements of the customer experience have been optimized to produce a product that is intuitive and easy for all types of users – whether it's experienced records managers or scientists working on lab tests or clinical trials.
Dashboards allow records managers and other types of users to view the metrics, recent transactions, priorities and items flagged for immediate attention. This at-a-glance health check allows records managers to quickly mitigate business risk and focus on activities with highest business value.
As a hosted solution, the product is accessible to records managers and knowledge workers in every geography, 24x7.
21 CFR Part 11 Compliance
Title 21 CFR Part 11 of the Code of Federal Regulations requires Life Sciences organizations to comply with the criteria that define whether electronic records and electronic signatures are considered to be trustworthy, reliable and safe. 21 CFR Part 11 applies to all GxP practices. OmniRIM provides multiple layers of security to ensure 21 CFR Part 11 compliance. System activities are registered, in particular to what the user does that relates to research, development and manufacturing. The logged information is secured appropriately and cannot be changed once logged – not even by an administrative user.
File Plans & Taxonomy
OmniRIM Records Center supports a diverse structure allowing for multiple file plans. A single OmniRIM implementation can support individual file plans for R&D, manufacturing, operations and even acquired companies with their own taxonomies. International life sciences organizations may maintain individual file plans for each of their international offices or subsidiaries.
Pre-defined Record Types and Metadata Elements
OmniRIM Records Center Life Sciences solution includes predefined record types, lists and metadata elements that are essential in the management of your accounting, environmental, engineering, human resources, marketing, operations, R&D and manufacturing records. OmniRIM applies common metadata elements across multiple record types empowering you with the ability to locate a diverse set of records relating to a single common metadata fields. OmniRIM's predefined managed lists and lookups for Life Sciences organizations increase efficiency and accuracy by alleviating the need for users to memorize and continually enter complex data, thereby reducing data entry keystrokes, while ensuring the data entered is correct across all affected record types.
Audit Controls
OmniRIM allows records managers to enter a Reason for Change any time a record is edited or amended and saved. Integrity of audit logs supports the immutability of vital records (also referred to as non-repudiation of records). Any change to the record is traceable in the audit trail. Audit information must be logged in a way that no user could say that the information is invalid. For example, claims that someone could have tampered with the information. One way of assuring this is by means of digitally signing activities.
Systems Validation
OmniRIM is designed to reduce the complexity of the distinctive compliance requirements facing Life Sciences organizations. Ensuring that a life sciences organization meets all the IQOQPQ validation requirements can take a significant amount of time and money. OmniRIM gets Life Sciences organization through the IQOQPQ validation process better, faster and cheaper. OmniRIM provides processes and a software testing environment that enables validation companies like Rusco to reduce the scope of validation testing, and implement an optimal plan. This saves our customers hundreds of thousands of dollars, in addition to implementation time.
International Date Stamping
For organizations with facilities in many parts of the world, it is necessary to track the accurate date and time of an activity for a record. OmniRIM’s international date stamping functionality ensures accuracy every time and reduces potential mistakes and confusion.