Case study about Kelaroo focuses on E-Notebook's ability to cope with an organisation's administration and security requirements - particularly key for 21CFR11 compliance
Large and growing enterprises are facing a new challenge to their core missions of developing and producing new products, whether those products are food, therapeutic pharmaceuticals, medical devices, cosmetics or other products designed to enhance public health.
This challenge is the complexity of complying with government regulations designed to protect public health and safety.
The most notable of these is Section 21 Part 11 of the Code of Federal Regulations, which establishes the standards by which the US Food and Drug Administration will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures.
The rule governs electronic records throughout their lifecycle from creation through modification, storage, and final transmission to the FDA.
Although 21CFR11 has been in the draft stage for almost a decade, final regulations have recently been created and enforcement of these regulations is beginning to take place.
Two important components of compliance are the positive identification of the person creating or modifying data records, and the use of audit trails for the data and system parameters affecting its collection and management.
This implies the use of software and computer systems that provide adequate security, protection, and audit trails for collecting and managing data.
CambridgeSoft software products, such as E-Notebook and Document Manager, are at the leading edge of the integration of corporate knowledge management with 21CFR11 compliance.
These products are designed such that as your organisation reviews its internal processes for 21CFR11 compliance, the software can be configured to support your internal processes.
Major requirements of 21CFR11, such as electronic signatures, audit trails, and long-term archiving, are incorporated within the routine workflow your company uses to generate the critical information required by your research, development and production.
In addition, E-Notebook and Document Manager can be integrated with existing systems that contain critical data.
This next section features a case study about Kelaroo and focuses on E-Notebook's ability to cope with an organisation's administration and security requirements. Such capabilities are particularly key for 21CFR11 compliance. Robert Feinstein is the chief scientific officer of Kelaroo, which provides biotechnology companies with a professional resource for the design, deployment, management, customisation and integration of chemical and biological informatics systems. After obtaining a PhD in biomedical sciences, he progressed through three biotech start-up companies in San Diego as a molecular modeller, scientific application developer, project leader and finally director.
Throughout his tenure, Robert has served chemists and biologists dedicated to drug discovery. Because Kelaroo specialises in assembling and deploying low maintenance cheminformatics systems for companies that typically have few or no IT professionals in house, administration and maintenance were considered to be critical features.
E-Notebook Administration.
The system provides an Administrator application whereby new users and groups can be defined, users can be added to groups, and the properties associates with various objects (eg, reactions, reactants, products, spectra, etc) can be defined.
In addition, default security settings for each user can be set by the Administrator, defining with whom they share new pages and collections.
The Administrator application is clean in design and simple in operation.
No expertise in software or database administration is required, thus enabling virtually any scientific professional to assume the role of administrator. However, like any highly configurable application, you must have a clear idea of what you want it to do, and be aware of the ramifications of how you do it.
This is particularly true in regards to intra- versus inter-project security, which is a significant issue for most biotechnology companies today.
It is important for administrators to realise that the E-Notebook Administrator application provides functionality above and beyond that provided by the E-Notebook client application itself.
When the administrator logs into the E-Notebook client, they have access to everyone's notebooks, and can perform many actions such as altering security settings and defining new project collections.
Thus, for granular security and maintenance issues, the administrator needs to also be adept at using the E-Notebook client.
Collaboration with security My first real test of E-Notebook was to see if I could configure it to support an organisational scheme typical of biotechnology companies that engage in multiple collaborations with potentially competing pharmaceutical companies.
I then sought to compromise the security of my collaborative scheme from the perspective of a standard user (ie, non-administrator).
Although every biotechnology company is unique, I have seen many that have a similar organisation.
Typically, project teams are designated that consist of multiple chemists and one or more biologists working on a particular receptor or enzyme target.
Because these chemists and biologists also belong to their respective departments, a true matrix organisation results.
Project-specific data needs to be visible only to members of that project, although certain managers and executives need to see all corporate data.
To complicate matters, different projects may have to share particular resources, such as quality control. Furthermore, people are often moved from one project team to another.
E-Notebook users can be assigned to one or more projects using the Administrator application.
This by itself does not accomplish much, since membership in a project team does not provide project-level security privileges.
However, individual user accounts can grant other users or groups read or read/write privileges to their notebook contents.
Thus, if the administrator is diligent in assigning access privileges only to groups, and assures that group membership is always up to date, most security mandates can be satisfied with a minimal amount of effort.
The final step in allowing for collaboration requires that the administrative user, via the E-Notebook client, grant each user's project group(s) read access to the user's 'home' collection.
This allows fellow group members to move up the collection hierarchy to see other users' notebooks.
If you expect that notebooks should only be edited by their owners, then owners' accounts should only grant read access to the groups that need to view their notebooks. Alternatively, if you wish to allow multiple users to edit a single notebook (eg, an instrument log), the administrator can grant read/write privileges to the appropriate groups.
This brings up a peculiarity in the E-Notebook application-the security settings for a user's notebook and its pages indicate that the groups to which the user belongs have read/write privileges, when in fact they do not.
Explicitly including the owner in the list of user/group names and indicating that they have read/write (while their groups have only read) access would solve this problem.
Once the user accounts, project groups and security settings are established, the collaborative aspect of the E-Notebook application works very well in that access and editing restrictions are well enforced. It is worth noting that changes to a user's project group affiliations and/or changes to the access privileges granted by that user only affect new notebooks and pages created by that user.
This makes sense in that prior teammates would need to have access to prior work and prior work only.
In contrast, changes to an existing notebook's access privileges (which can only be done by the Administrator via the E-Notebook client) apply to all affected groups immediately.
Conclusion: "Considering the challenges inherent in designing a scientific collaboration system, E-Notebook is a quality product.
I would rate E-Notebook a 4 out of 5" - Robert Feinstein, Keraloo.
CambridgeSoft Software, including E-Notebook, is supplied and supported in the UK and Ireland by Adept Scientific.
