SciCord ELN Frequently Asked Questions (FAQ)

Benefits

What are the benefits of the SciCord ELN?
  • Improved traceability: SciCord ELN keeps track of all resources used in the laboratory such as users, instruments, samples and reagents. It also provides multiple security levels and a data audit trail traceability and compliance with regulatory requirements like FDA 21 CFR Part 11 and ISO 17025.
  • Improved sample management: SciCord ELN allows you to define properties for sample identification such as date of receipt, date of sampling, batch number and barcode identification.  SciCord supports work requests (testing or activities to be performed), sample results, and sample inventory.
  • Improved productivity: SciCord provides an efficient review process to eliminate data review backlogs which plague many laboratories.
  • Easy access to data: the integrated search functions allow users to find information more quickly.  An integrated DataMart supports queries and reports.
Does an ELN have an impact on intellectual property?

Yes. From an intellectual property perspective, the use of an ELN has several advantages. It provides a more secure environment than paper because it can limit the access to data based on profiles. It also helps to create a written record of actions and all required traceability including witness. The ELN integrates secure mechanisms such as time stamps and digital signatures on sensitive actions that cannot be changed. Consequently, it’s possible to prove the date of experiments. In addition, the electronic format helps avoid readability problems which you would sometimes see with scanned documents or handwriting.

Which Instruments are compatible with SciCord?
  • SciCord deploys several instrument interface strategies, depending on the type of instrument and the level of interface required.
  • Real time data collection from instruments such as balances and pH meters is provided by monitoring an IP address. This means once a scientist identifies an instrument, a real time display of the instrument output is provided and the scientist records the instrument data directly.
  • Some instruments feature a result database. SciCord can connect to the database, obtaining result sets, and recording pertinent information.
  • For instruments which only supply a printed report, SciCord supplies a special printer driver to capture the printer output directly into the SciCord database as a pdf file.
  • For instruments which generate files, the files identified are attached to the document/experiment with appropriate context.
  • Finally, custom solutions are available to support interface to more exotic instruments.
How easy is it to get data back out of the system? Is all information indexed and searchable? Can users query and combine data from multiple experiments, not just return a list of experiments?

SciCord provides several levels of data reporting.  The first level is at the document or experiment level where the results generated by an analysis or process are summarized and formatted to facilitate understanding of the outcome(s).  Summarization of data can also be accomplished at the sample or lot level.  Finally, a DataMart is supplied which organizes analysis or process data across experiments/lots.  The DataMart is constructed to optimize queries and retrieval using JMP (SAS), Spotfire (Tibco), or Power BI (Microsoft).

Industry And Sectors

Which Industry sectors are targeted by the SciCord ELN platform and what types of companies can use the SciCord ELN platform?
  • The SciCord Electronic Laboratory Notebook (ELN) was designed for compliant analytical and manufacture groups within the Pharmaceutical Industry.
  • SciCord has an industry leading inhaled product application.
  • SciCord ELN is suitable for organizations requiring a compliant documentation system from late Phase II through manufacture and is scalable to support individual laboratories to global organizations.

Security and IP

How does SciCord manage any potential threats?

All SciCord systems are kept up to date with the latest patches and security protections. External penetration tests are conducted on a regular basis, one for every major release of the software, which is typically once every year.

What policies are in place for Identity and Access Management of the software?

SciCord maintains a password policy which covers a certain level of complexity, minimum length (8), lockout, etc. A Least Privilege Access policy is in place, which means that a User is able to access only the information and resources that are necessary for their legitimate purpose. Also, there are controls to review and assess the appropriateness of access at least once every 12 months.

Who provides the Datacenter for SciCord?

SciCord is a cloud-based product that is hosted by Microsoft Azure, which maintains certifications against major security frameworks.

Does SciCord maintain Business Continuity and Operational Resilience plans?

Yes. In our SLA we include Continuity Plans, which are tested and validated.

Has SciCord ever undergone an Audit?

Yes. SciCord has been through compliance inspections and external audits.

How does SciCord handle the application and interface security?

SciCord conducts development on-premise, using a virtual machine package that is standardized for all developers. There are policies and guidelines in place, as well as a web-based access model, to manage how the process is performed. Also, SciCord does not outsource any of its code development. The development follows an SDLC process, which includes quality control, testing policies, support policies, etc. The SciCord Solution code is regularly tested against OWASP top 10; e.g. Qualys and TinFoil.

Does an ELN have an impact on intellectual property?

Yes. From an intellectual property perspective, the use of an ELN has several advantages. It provides a more secure environment than paper because it can limit the access to data based on profiles. It also helps to create a written record of actions and all required traceability including witness. The ELN integrates secure mechanisms such as time stamps and digital signatures on sensitive actions that cannot be changed. Consequently, it’s possible to prove the date of experiments. In addition, the electronic format helps avoid readability problems which you would sometimes see with scanned documents or handwriting.

Is your IP system safe?

Yes! Each SciCord customer is provided with an isolated environment in the award-winning Azure cloud to assure data security potential. Encryption of your stored data in the SciCord database safeguards your information from intrusion. Encryption is also implemented to safeguard your Information when transmitted between your site and the Cloud servers.

Support and Training

Is it possible to integrate with our other systems?

Yes. SciCord will integrate with third party or in-house metrology, LIMS, SAP, and document repositories. Custom integrations are available at cost.

What are the distribution modes of the SciCord ELN?

SciCord is offered using the SaaS (Software as a Service / Cloud) model.  This means all infrastructure, maintenance and support are provided by SciCord.  The product is offered with either a monthly or annual subscription.

How does the Scale (Size, People, and Processes) of the Lab affect the ideal informatics set-up?

The scale of an organization can have an impact on informatics requirements. Smaller organizations can rely on interactions between individuals to “find” information and facilitate communication within and across projects. As organization size increases, the communication barriers naturally increase, often dramatically. For larger organizations, searching for information and efficient collation is paramount. Large organizations require a DataMart solution to facilitate finding and organizing information across multiple projects and over a potentially long time frame.

Which Instruments are compatible with SciCord?
  • SciCord deploys several instrument interface strategies, depending on the type of instrument and the level of interface required.
  • Real time data collection from instruments such as balances and pH meters is provided by monitoring an IP address. This means once a scientist identifies an instrument, a real time display of the instrument output is provided and the scientist records the instrument data directly.
  • Some instruments feature a result database. SciCord can connect to the database, obtaining result sets, and recording pertinent information.
  • For instruments which only supply a printed report, SciCord supplies a special printer driver to capture the printer output directly into the SciCord database as a pdf file.
  • For instruments which generate files, the files identified are attached to the document/experiment with appropriate context.
  • Finally, custom solutions are available to support interface to more exotic instruments.
What are the greatest challenges faced in the implementation process?

The single greatest challenge for most organizations is committing the resources required to push the implementation over the finish line. Any implementation requires contributions from the group of individuals most skilled in the target processes.  These folks are typically also the most overworked people in the organization.

A second challenge is the boundaries between groups within an organization. Think analytical and QA or manufacture and QC. One group is typically driving the process and the other group may not be focused resulting in delays.

What is the chance that the company will switch technologies and force an expensive migration?

SciCord is provided as a service. This means technology updates are transparent to the customer.  To use SciCord, customers only need PCs running Windows – no investment in expensive hardware or support staff.

What level of support is offered?

SciCord offers full support for implementation and customization. Each client is assigned a Project Manager, who coordinates the deliverables between Lab Personnel and SciCord QA, Template Developer and Testers. All staff speak English, and some speak Italian fluently. SciCord provides a project management tool (RedMine) to coordinate the implementation activities.

What is the typical number of hours of admin time required to upgrade for a major release and a minor release?

Upgrade of a GxP compliant solution is often difficult and time consuming. SciCord provides a complete verification documentation set which often allows a customer to approve an upgrade without on premises testing. Once approved, SciCord upgrades the customer environment to the new release overnight.  No additional effort is required by the customer.

How easy is it to extend the application? Does it require IT or super-users? How long does training take to make modifications and how extensive is the API for modifications?
  • The application is extended using standard spreadsheet (Excel) functionality.  This means anyone with spreadsheet expertise can implement new functionality.  Training for simple extensions requires just a few hours.  The training required for more complex extensions is dependent on the level of Excel expertise.
  • SciCord provides a parameter driven API language.  Most manipulations require a single line of instruction.  The API can be understood in a single 4 hour training session.
How local are resources and how available are resources for deployment, training and extensions?
  • SciCord is based out of Cary, North Carolina with a support center in Verona, Italy. Support is provided during 8-5 office hours for time zones throughout Europe, and the east coast and west coast of the USA.
  • SciCord employees are available for training and implementation activities on-site or remotely.