SampleManager LIMS™ Software - FAQs

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What are the three deployment options for SampleManager LIMS Software, and what are the benefits of the Hosted Cloud environment?

SampleManager LIMS Software has three deployment options and can be implemented on:
- An AWS Hosted Cloud environment managed by Thermo Fisher Scientific
- An on-premises implementation managed by the customer - Customer’s cloud-hosted solution

Thermo Fisher Scientific’s cloud-managed solution offers a tremendous amount of value. First, an annual hosting fee is calculated based on the number of licenses required. This allows for its size to be tailored to your requirements. Second, our Support Team takes care of the systems management providing many benefits including:

- Data secured both in motion and at rest using industry-standard encryption
- System managed with integrated auto-recovery for hardware failures
- Real-time intrusion detection and prevention
- Infrastructure and User Login monitoring
- 24-hour recovery time objective and point objective

How does the audit configuration in SampleManager LIMS Software ensure that audit events and transactions are recorded for all necessary fields, and what details are captured for each event?

The audit configuration is robust and flexible, ensuring audit events and transactions are recorded for any and all fields that demand audit logging. Each event captures what was changed (new and old value), who made the change, when they made the change, and the reason (unless silent), thus ensuring that previous values are always kept for future reference.

Can SampleManager LIMS Software alert users when the stock is running low, with "low" being defined by the user?

Users can be notified when a stock is running low or when its expiry date nears (or both).

If a stock is past its expiry date, the user may be alerted. Alternatively, the user can be prevented from using expired stocks entirely.

Is the Electronic signature in SampleManager LIMS Software compliant with Eudralex Vol IV Annex 11?

Please see "SampleManager 21 CFR 11 Compliance Guidelines 2023", SampleManager Software provides flexible configurations to allow compliance to electronic records and signatures requirements under Eudralex Vol IV Annex 11 as well as 21 CFR Part 11. SampleManager LIMS Software has username and password requirements. Compliant signing ceremonies can be required at the appropriate signature steps. Each signing ceremony requires the username and password and is permanently linked to the record along with the date and time the signature was applied. Permission controls can also be configured to ensure only those who are authorized to perform an activity have the ability to do so.

How do Test Schedules in SampleManager LIMS work, and how can they be used to automatically assign tests to samples based on factors such as sampling location?

Test Schedules in SampleManager LIMS Software allows a pre-defined list of tests to be assigned to samples. For example, a workflow configuration can be used to assign a specific test schedule based on the sampling location, thereby assigning pre-specified tests to sample points automatically.

How does SampleManager LIMS Software connect to instruments, read the values, and automatically store them within the LIMS database?

The Sweeper service can be installed on servers and workstations that store files containing information that you want to transfer to SampleManager LIMS Software. The Sweeper service connects to the SampleManager WCF service of your SampleManager LIMS instance.

The configuration information for each Sweeper service is defined by a sweeper entity in the SampleManager LIMS instance. SampleManager Software can process data sent by the sweeper with an import definition or a workflow.

Based on parsing and mapping configuration, derived tests results are automatically imported into SampleManager Software after analysis is completed, on a sample-by-sample or test-by-test basis.

How are analysis records created and used in SampleManager LIMS Software, and what types of result components and metadata fields can they include?

Analysis records can be created in SampleManager LIMS Software, which enables their application in a sample to create a test. These records contain information about the result components of the analyses, which can be of various types, including numeric, calculated, text, option, Boolean, file, and more. Similar to other entities, analyses also have configurable metadata fields that allow users to define the necessary information to be stored with an analysis record.

What authentication mechanisms does SampleManager LIMS Software provide, and how does it support third-party identity providers and multi-factor authentication?

SampleManager LIMS Software provides many mechanisms of authentication, such as:
- Okta or Microsoft AD, including SSO utilizing OAuth 2.0 and OpenID Connect or LDAP (rather than SAML) protocols to enable authentication via third-party identity provider (IdP).
- We can also support IdP provided MFA through standard MFA or bio-metric login (on devices that support bio metric logins).
- In addition SampleManager Software is equipped with its own secure authentication system, using system-defined username and password with configurable complexity requirements.

Does SampleManager LIMS Software include quality control plotting and management functionalities, such as Shewhart Charts?

Statistical quality control, or SQC, is the use of statistical methods to monitor and maintain the quality of products and services. The SQC module for SampleManager LIMS Software contains user-configurable control charts that obtain data from the SampleManager Software database.

When using SQC within SampleManager Software, you can:

- Create user-customizable control charts. - Save the charts for later viewing or modification. - Monitor trends in data by setting rules for marking a data point. - Mark specification limits on the charts to enable identification of data that approaches or exceeds these limits. - Print charts. - Copy SQC chart properties to make a new SQC chart. - Remove charts. - Use charts in reports. - Schedule an SQC report to print or send via email. - Schedule trend checking. - Customize a test or method workflow using the Find SQC Trend node in the workflow.

How does SampleManager's Calculation Builder function, and what types of calculations can it perform using values from other test results?

SampleManager LIMS Software is equipped with a Calculation Builder that uses a variety of mathematical functions to perform all kinds of calculations. These calculations can be applied to results, using values from other test results. This allows for the mean of the result values in an analysis to be calculated, or standard deviations to be used. A wide range of standard calculation "building blocks" are available, and these can be used in a custom formula, similar to how Microsoft Excel handles the building of expressions.

Is SampleManager LIMS Software capable of handling the use of special characters in relation to Irish, German, French, and Spanish?

SampleManager LIMS Software uses UTF-8 and supports a wide range of languages.

SampleManager Software has translation capabilities, menu, messages, and several elements of the user interfaces can be translated into local language. SampleManager Software has built in translation plugins to use with the translation services from Azure, Google or AWS ; translation can be done automatically using these plugins.

Default languages can be set, and each individual user can choose their preferred language (if given the user right to do so).

How can the Auditor in SampleManager LIMS Software be configured to record significant changes to the database, and what details are captured during an audit event? What types of audits are supported?

The Auditor can be configured to record significant changes to the SampleManager Software database. When an audit event is triggered, the auditor will record:
• The changes that were made
• The operator responsible for the changes
• The time and date
• The reason that the operator gave for making the changes (if the audit is configured to prompt for a reason.)

The Auditor operates by monitoring the database for specific changes in the data. When it is configured, the fields and tables that are to be monitored must be specified. For each field or table, the type of changes that will trigger an audit must be specified.

Audits can be one of two types:
• Silent Audits give the user no indication that an audit transaction has been recorded.
• Prompt Audits open a dialog box asking the user to state the reason for the action.

How does SampleManager provide functionality for administrators to manage usernames and enforce password complexity, and what integration options are available for Active Directories and Single Sign-On providers?

SampleManager LIMS Software provides functionality for administrators to define usernames for personnel, and to enforce a configurable complexity of passwords. Additionally, the system can be integrated with Active Directories and is also capable of interfacing with Single Sign-On providers using OAuth 2.0 protocols.

How does SampleManager LIMS Software handle event logging and auditing, and how is the auditing tailored to the specific needs of an organization during the implementation project planning?

All events within SampleManager LIMS Software can be logged. We work closely with your risk assessment team to tailor auditing to the specific fields and tables that are relevant to your organization, to help ensure that your audit table does not contain extraneous or meaningless information. As we begin implementation project planning, we will assess which tables and fields require audit tracking to help ensure optimal performance and compliance.

How does SampleManager LIMS Software handle location information and storage condition data for samples, and how can this information be used to display useful dashboards?

Location information can be stored alongside samples in the system. This can be updated as the sample moves through the lab or from different areas of the building. Locations have hierarchical properties, so each location can have a parent location, which can have its own parent and multiple child locations, to reflect the true nature of locations; Buildings > Rooms > Areas > Benches etc.

Storage condition data can also be defined for each individual sample. Together with the above, this information can all be configured to display useful dashboards, for example the Biorepository solution includes a number of GUI dashboards to help drive efficient sample storage processes.

How does the results entry window function in SampleManager LIMS Software, and what options are available for entering results for single samples or groups of samples?

Results can be entered in the results entry window for a single sample or for a group of samples, as desired by the user. Each time a sample is selected in the left pane, its tests and results will appear in the right pane.

How does SampleManager LIMS Software provide the ability to export dynamic report results, such as Certificates of Analysis (COA), in a PDF format?

SampleManager Software includes a Certificate of Analysis functionality, which employs report templates in a validated, version-controlled manner. These reports are exported as PDFs. The certificates can be processed further either manually or automatically, e.g. mail, save and/or print.

How does SampleManager LIMS Software handle the comparison of test results against specification limits, and what features does it offer for managing incidents and visual indicators?

SampleManager LIMS Software automatically compares the results of a test against the (multiple) specification limits applied. The workflow functionality allows for different actions to be performed according to the results and their comparison with specification limits. SampleManager Software is also equipped with an Incident Management feature, which can investigate any kind of incident, such as OOS and OOT results, etc. Incidents are recorded with a unique identifier and are linked to the entity (sample, test, result, etc.) that prompted them. SampleManager Software also provides visual indicators configured to your specifications based on colors, font types, etc.

What encryption options and capabilities does SampleManager LIMS Software have?

All data transfer in SampleManager LIMS Software is encrypted.

The security protocol includes AES-256 encryption at rest, ensuring that all communication with the AWS managed instance is safeguarded using industry-standard 256-bit encryption complemented by a 2048-bit public key.

How does SampleManager LIMS Software handle user authentication and permissions, and what are the different mechanisms supported for verifying a user when they attempt to log in?

SampleManager software is equipped with a roles functionality, which allows for permissions to be configured in a granular way. User account management should be granted only to users with system administrator access.

The SampleManager Software login process verifies that the user is allowed to access SampleManager Software, and links the user to a unique record held in the PERSONNEL table. The record stored in the PERSONNEL table serves two purposes:

- It controls which options appear on the menu when the user logs in, and which groups of static data the user can access.
- The identity of the PERSONNEL record for the current user is recorded against actions carried out on information in the database, such as the modification of an analysis or the authorization of a sample.

SampleManager Software supports the following mechanisms for verifying user logins:

- SampleManager authentication – The user logs in using a username and password that are managed within the SampleManager PASSWORD table. Each record in the PASSWORD table is linked to a single record in the PERSONNEL table. This is the default authentication mechanism.
- Domain authentication – The user logs in using a username and password that are verified by a domain controller on the network. When the domain controller verifies that the user is allowed to access SampleManager Software, information from the domain account is used to select the record in the PERSONNEL table that defines the SampleManager security settings for the user. When domain authentication is used, SampleManager Software can be configured to either prompt the user for their domain username and password on login, or to obtain the username and password information from the current Windows session on the client (proxy login).
- Single Sign-On authentication – The user logs in to a third-party identity provider, such as Okta or Centrify (supported protocols are OICD/OAuth2.0 or LDAP, rather than SAML).
When SampleManager Software starts and the identity provider verifies that the user is allowed to access SampleManager Software, information from the identity provider is used to select the record in the PERSONNEL table that defines the SampleManager security settings for the user.

How does SampleManager LIMS Software allow for the specification of a retention period for captured data, and how can it enact this based on date-based fields or a future event?

Retention periods for data can be configured in SampleManager Software, triggering actions when reaching a specified or calculated date or in the case of an event.

What are the different ways samples can be registered SampleManager LIMS Software, and what is the process for manually logging in a sample?

Samples can be registered in the system in a number of ways. For example, samples could be automatically logged in using the scheduler to schedule the time, day, week, month, and year for sample collection or sample processing. Samples can also be logged in based on a sample manifest, enabling the import of a document into the system to trigger the registration of samples. Alternatively, samples can be manually logged in.

When logging in a sample manually, the user is asked to select a workflow (which guides the sample in its lifecycle within the system, applying relevant business logic where required), the number of these samples to login, and the metadata for that sample. They are then able to add specific tests to the sample if they have not already been assigned to the sample based upon the workflow selected.

Does the administrator role have the ability to define and implement roles, user groups, and access rights for users in SampleManager LIMS Software?

The system administrator (or any role that has the right to create/define new users) can define and implement roles, user groups, and access rights. A combination of Sites, Groups, Roles and individual User Rights, can be created as follows:

- Sites allow you to identify data that belongs to a specific geographic location or business unit. Each site is associated with one or more group.
- Groups are the main mechanism used to restrict user access to data. If a record is assigned to a group, only group members can view that record.
- Roles are used to restrict the menu options which a SampleManager Software user can access. Each role is associated with a list of menu options and privileges. An operator who is assigned a role can access any of the menu options on the list or perform any action that requires one of the assigned privileges. <

How should numerical result values be entered or calculated, rounded according to defined rules, and reported with a specified number of decimal places, while ensuring that the raw data is kept complete and without rounding?

Results can be entered into SampleManager LIMS Software interactively or remotely using instrument integration software. As standard, SampleManager LIMS can store the following types of results: Numeric, text, Boolean, filename, character, date, interval, option, calculation, list, and entity. For numeric results, rounding, decimal places and significant figures can be defined. Raw results are stored separately from rounded values.

What data protection is there in SampleManager LIMS Software for in transit and at rest data?

Thermo Fisher's managed cloud service offers end-to-end encryption in transit and at rest. Data in transit between the customer network and the dedicated AWS VPC is encrypted via SSL/TLS 1.2 for public traffic or IPsec VPN tunnel for all other traffic. All data in transit across the AWS backbone is similarly encrypted via SSL/TLS 1.2. All three data stores used within the environment (S3, FSx for Windows, and RDS for Oracle) are encrypted at rest using AES 256 standard. Cryptographic keys (if utilized) are stored in AWS KMS (Key Management Service).

As SampleManager Software is hosted in AWS, it benefits from the DoS and DDoS layers provided by AWS (AWS Shield).

The responsibility for encryption mechanisms in on-premises and customer-hosted installations falls on the customer.

How will SampleManager LIMS Software be able to read (scan), create, and print unique GHS-compliant barcode labels?

SampleManager LIMS Software incorporates a built-in label designer tool, eliminating the need for any supplementary installations. This tool simplifies the creation of label templates, which can include any data or metadata from the SampleManager Software database, inclusive of GHS symbols. Additionally, it facilitates the printing of barcodes in nearly 20 different formats.

It allows users to drag and drop fields and design components onto the design pane. Labels can include all kinds of barcodes and QR codes. Label shapes and sizes are configurable for all types of label applications. The Workflow feature in SampleManager Software automates label printing activities wherever required.

Label printing activities can be tracked using the Auditor feature.

What is the recommended method for implementing the SampleManager LIMS software in our organization, and what are the components of the implementation project? Can you describe the method and provide a detailed breakdown of the suggested approach?

The Thermo Fisher Digital Science and Automated Solutions Professional Services team has significant experience and expertise in local and global LIMS implementation projects. Our goal is to provide customers with a laboratory software ecosystem that benefits their processes, science, and people, and complements their organizational strategy.

The key to successful project delivery is centred on a well-established project management service, delivered by experienced project managers and technical teams. Governance on a day-to-day basis ensures that delivery is kept on schedule and the project teams are consistently managing project issues and risks with appropriate mitigation.

- The project manager will be responsible for leading the team and working with the architect and technical lead to drive all aspects involved in implementing the live system and service. - Thermo Fisher project governance and ISO-accredited QMS process will help ensure a successful completion of the project with a high level of quality during all phases.

Project approach

The project will follow the services provider’s processes and approach. The service provider will provide a suitability qualified project manager and other resources to manage the delivery and execution of the service provider’s deliverables and responsibilities as defined within the Statement of Work, following the appropriate methodology.
A project initiation meeting will be held with all the key stakeholders to formally launch the project and to ensure that the project participants have a clear and shared understanding of the project and expectations. The meeting will either be conducted at a customer location or remotely . The key items to be addressed during the meeting include, but are not limited to:

- The project schedule and detailed plans for the initial phase of the project
- Project resources
- Risk analysis and mitigation
- A review of the deliverables and acceptance criteria
- Requirements management – how projects will be documented and managed
- Planning for service provider’s customer experience program engagement points
- Agreement on the process for recharging for expenses or other items
- Project communication and reporting
- A review of the project governance processes, and other matters outlined in the document.

How can SampleManager LIMS Software allow the creation and management of sample plans (individual or batch wise) and test plans, including creating new test plans, assigning samples to plans, and tracking samples through testing?

The workflow engine is the driving force behind all planning functionalities.

Samples can enter the system in a workflow or be added to a new workflow. This process automatically assigns tests, monitors processing, and allocates tests or testing methods to designated users.

Can SampleManager LIMS Software track reagent usage through workflows, including reagent receipt and lot numbers attributed to workflows and samples for quality assurance?

The reagent, standard, and other consumables can be managed as different types of stock with information such as lot number for each stock batch, label, storage location, hazard, available amount, ordering, supplier, and parameters for use in calculations. A new batch of stock is created once it's received in the lab. Reagents can be directly linked to analyses for use in testing workflows allowing lab users/managers to see when the reagents are required and how they are consumed. Quantity is updated from the consumption and new reagent receipt. The low limit and expiry date are monitored with an alert.

Does SampleManager LIMS Software include features for tracking and managing calibration schedules, maintenance records, and equipment validation documents, as well as sending reminders and alerts for upcoming calibration or maintenance events?

SampleManager LIMS Software comes with a comprehensive instrument management module, which allows users to configure the LIMS to run in compliance with ISO 17025. Instrument and equipment calibration and maintenance can be managed down to individual component parts. Electronic instrument logbooks are provided. Calibration samples can be scheduled to conform to a freely definable schedule. Instrument performance is monitored through statistical Analytical Quality Control sample results, including individual, run and Q charts and normality checks to move from setup to deployment. The module enables labs to: meet Standard ASTM D6299, schedule QC samples to rules and monitor results collected by an instrument, represent data through charts and dashboards, check failure, warning and trend rules, and trigger actions as appropriate.

How can analyses be applied to a sample in SampleManager LIMS Software, and what options are available for assigning analyses?

Analyses can be automatically applied to a sample based on any number of conditions: the sample type, the location to which it is assigned, etc. Alternatively, analyses can be added to a sample manually, allowing the user to choose the sample to assign from a drop down, searchable list. In addition, 'Test Schedules' allows a collection of analyses to be bundled together and scheduled to be applied to a sample at once.

Is there a backup and recovery process for SampleManager LIMS Software designed to ensure that data can be recovered in the event of unexpected loss?

SampleManager LIMS Software should be integrated in the company's backup and recovery plan.

SampleManager LIMS Software provides performance monitoring and alerting tools. Indexes can be created/recreated from within the application. Other database tasks like defragmenting indexes/tables, managing tablespaces, etc. can be done using appropriate database management tools (SQL Server Management Studio, e.g.).

On hosted systems, we have a defined Disaster Recovery, Backup and Restore and Business Continuity Plan that is documented and verified as part of our Quality Management System (QMS). Data is backed up daily and before changes to systems (e.g., upgrades). The automated backup feature enables point-in-time recovery of the database. With automated backups, full daily backups of the database are captured with transaction logs. When we perform a point-in-time recovery, transaction logs are applied to the most appropriate daily backup to restore the database to the specific time requested. We leveraged the backup and disaster recovery processes from Amazon Web Services, our hosting partner.

Data restoration tests are performed annually. Backups are encrypted at rest with AES-256 encryption.

Does SampleManager LIMS allow exporting of results at both individual and aggregate/grouping levels, in formats such as Excel and PDF?

The system has an export function to export all data shown in the Explorer to one of the following formats: Excel, CSV, Rich Text Format, PDF and single web page file.

Reports can be exported manually or automatically.

Does SampleManager LIMS Software support labels that include both human-readable and barcode information?

Yes, the label designing tool in SampleManager LIMS Software offers exceptional flexibility. It enables users to incorporate human-readable information, barcodes, images, and symbols (such as logos or GHS symbols) onto labels. Additionally, users can define the size and shape of labels required by their label printer and container(s).

In addition, if the label comes from an external software, the data from the barcode can be entered into SampleManager LIMS Software via a barcode scan, or can be used to identify the sample (assuming the SampleID is aligned in SampleManager LIMS Software and the external application).

What kind of audit functionality does SampleManager LIMS Software have?

Audits can be one of two types:

• Silent Audits give the user no indication that an audit transaction has been recorded.

• Prompt Audits open a dialog box asking the user to state the reason for the action.

How does SampleManager LIMS Software manage reagent and consumables inventory?

Management of reagent inventory is provided through SampleManager LIMS Laboratory Stocks and Substances functionalities according to ISO 17025 guidelines. Inventory control includes use of stocks, consumables, and orders.

The Stock Management feature in SampleManager LIMS Software tracks the status and usage of all laboratory materials, reagents, and consumables. This functionality tracks expiration dates and quantities, issuing alerts of expiration and configurable low percentage or low amount. General ordering, disbursement, low level inventory indication and reporting are also provided. The Materials safety handling feature stores critical safety information for proper substance handling. Stock and inventory management dashboards provide visibility of laboratory consumables such as solvents, reagents and disposables. Procedures for destruction of materials can be configured and performed using the Laboratory Execution System available in SampleManager LIMS Software.

Will I be provided with online training materials for users and administrators, including installation guides and reference manuals for SampleManager LIMS Software?

The SampleManager LIMS Software documentation set includes context sensitive help, as well as manuals in PDF formats, including an Installation Guide, User Guide, Reference Guide and Configuration Guide.

User manuals are available for the product itself, including all aspects of function for the system, covering both user functionality and administration functionality.

Training materials are available online. Hard copy is available upon request.

Users also have access to the support resource site which hosts materials and tools, such as knowledge base articles, defect tracking, and user forums.

Is support/maintenance provided by Thermo Fisher Scientific, third- party vendor, sub-contractor, or another group?

All support actions are coordinated by Thermo Fisher Scientific Digital Science and Automated Solutions support team and TechOps, including AWS support for customers who opt for the Digital Science and Automated Solutions provided cloud hosting.

Comprehensive support channels:
- System support is available worldwide through multiple channels: voice, email, and internet.
- Our support desk utilizes a ticketing system to manage all requests, performing initial triage checks to prioritize issues according to the Service Level Agreement (SLA) within MSA/MLA.

Thermo Fisher Scientific’s experienced team operates on a follow-the-sun approach, ensuring technical assistance and rapid escalation for critical issues.
Support is offered during normal business hours. Turnaround time is dependent on the nature of the issue. Customers should expect a response to any request for support within 4 business hours. - - Support for critical errors is available 24 hours a day, seven days a week, including holidays.
Additional support features
- Knowledge base: Access to a comprehensive knowledge base with articles, FAQs, and troubleshooting guides.
- Regular updates: Clients receive regular updates on issues, resolutions, and system enhancements.

Is SampleManager LIMS Software capable of generating a view that shows trends within historical data, including sample results, quality control checks, non-conformances, and investigations?

Statistical Quality Control allows the graphing of historical data to identify outliers or trends over time. These graphs can be created automatically or manually, and can be configured to display specifications for the data item of interest. For example, showing the trending history for the most recent 30 Karl Fisher water content measurements.

Does SampleManager LIMS Software provide the ability to create user roles and assign users to these roles?

The system requires all users to be assigned to one or more roles; these roles determine the users' permissions within the system, such as the ability to create samples, enter data, modify workflows or approve data. The level of control granted to each role determines the extent of their influence over system actions.

The system has a default set of roles. Roles can be created or merged based on specific requirements. The default set of roles includes an administrator SYSTEM account, which has access to any configuration setting. Using this account, you can create new roles, assign relevant user rights, and assign the roles to specific users.

Can SampleManager LIMS Software integrate with Maximo to retrieve maintenance and calibration schedules and details for equipment status?

The system can integrate with external management software to retrieve maintenance and calibration schedules and details for equipment status.

Alternatively, the instrument management functionality of SampleManager LIMS Software can record maintenance and calibration schedules and details for equipment status. Instruments and instrument parts can be stored, and their status monitored in the system.

The user can log which instruments are used for which test, and instrument connectivity details can be added. For example, a balance may be added along with its maintenance schedule and connection details in order to communicate with the balance for pulling results data from the instrument.

Does SampleManager LIMS Software provide an audit trail report?

The audit configuration is robust and flexible, recording audit events and transactions for any fields that require audit logging. Each event captures:
- Both the new and old values of the changed field.
- Information about the person who made the change.
- The timestamp of the change.
- The reason for the change (unless silent audit).

Additionally, once the data is captured, it can be displayed as a report.

Does SampleManager LIMS Software allow for manual sample receipt?

Samples can enter the system in an "unreceived" state, where all dynamic entities in the system follow associated lifecycle workflows that indicate subsequent actions. Samples can be "received" into the lab through barcode accession, manual bulk action. Alternatively, samples that do not require accessioning can enter the laboratory with a status of "available" upon creation. This is particularly useful in scenarios such as creating a set of sample aliquots, where there is no need to receive them again. It is also applicable when processing a sample for analytical control purposes. The system tracks the time when actions are executed (such as the login or receiving of a sample), and can calculate time required for results delivery or any other time parameters as needed. All the related information stored in the database can be exported for use in different applications by querying database and applying filters as required.

Can SampleManager LIMS Software produce labels for samples that include the name, batch number, date of manufacture, and a place to initial and date?

SampleManager LIMS Software is equipped with a Label Designer, which allows the user to create label templates that can contain any data or metadata from within the SampleManager database. This is a standard configuration tool available in the system and allows users to drag and drop fields and design components onto the design pane. An advantage of this is that, once a sample is generated, the system can automatically generate a barcode label with the correct sample data encoded (e.g. sample ID). When the system creates the barcode, it dynamically pulls the data from the current sample, allowing the full automation of the label generation process.

Does SampleManager LIMS Software support an environment for training and demos?

SampleManager LIMS Software comes with three environments - development, testing and production.

SampleManager LIMS Software offers a TEST environment that can be used by the customer to run all test scripts against the system that are directly related back to the requirements. (Test is typically a copy of production to test out changes and get approvals before it is promoted to Production.)

Multiple instances can be installed alongside each other to provide environments for development, pre-production as well as the production instance. A number of tools are included with SampleManager LIMS Software to assist in the promotion of changes through these different environments.

Additionally, training on SampleManager LIMS Software is managed by our support team, who can spin up separate environments in which to conduct end-user training.

What is the disaster recovery architecture and process, including backup frequencies, backup locations, the use of fail-over mechanisms, and recovery time and recovery point objectives (RTO and RPO)?

SampleManager LIMS Software supports data backup and archival processes. Natively, SampleManager Software provides customers with two database schemas – the active database and the committed database. Data can be moved from the committed database to an archival database. The data from data tables can also be exported easily and quickly with provided tools inside the SampleManager Software. In addition, SampleManager Software can be configured to work with customer infrastructure backup resources and alike.

For customers who opt for the Thermo Fisher managed cloud in partnership with AWS, we provide a defined Disaster Recovery, Backup and Restore and Business Continuity Plan that is documented and verified as part of our Quality Management System (QMS).

Data is backed up daily before system changes (e.g., upgrades). The automated backup feature enables point-in-time recovery of the database. With automated backups, full daily backups of the database are captured with transaction logs. When we perform a point-in-time recovery, transaction logs are applied to the most appropriate daily backup to restore the database to the specific time requested.

SampleManager LIMS Software leverages Amazon’s comprehensive infrastructure to execute a backup and restoration process in order to maintain system availability for all hosted systems.

- Systems and data are backed up and backups are retained to meet the recovery objectives.
- The backed up image is stored separate from the system using Amazon Simple Storage Service (Amazon S3). This provides a highly durable (99.999999999% durability) storage infrastructure designed for mission-critical and primary data storage. Amazon S3 redundantly stores objects on multiple devices across a minimum of three Availability Zones (AZs) in an Amazon S3 Region.
- All backups are encrypted using industry-standard encryption algorithms.
- Restoration due to data or system corruption or loss is deemed an incident and is managed under the Incident Management Policy.
- The Technical Operations team will restore systems and data to address unrecoverable system failure, data corruption, or data loss.
- Customer stakeholders are notified prior to a planned execution of a system or data restore.
- Thermo Fisher Scientific will verify restored systems and data. The customer is required to verify that the restoration meets their expectations.
- All restoration procedures will be executed.

Does SampleManager LIMS Software allow the definition of user(s) to be notified when the sample status is changed?

Status changes in the system are part of the lifecycle - so a sample lifecycle controls what happens when a status changes.

These status changes can trigger events in the system, including notifications.

Can you describe the end-user training provided as part of the implementation?

Training is delivered as standard Thermo Fisher Scientific product training or as configured system training based on the customer’s specific configuration. General users will typically be trained initially in the standard Data Configuration for SampleManager LIMS Software. LIMS Administrators will be trained in SampleManager LIMS Software Administration. There will also be training for specific functional areas as required such as LES, Report Designer, Instrument Integration etc. Training on the configured system is delivered in a ‘Train the Trainer’ format.

Once the Administrators and Super Users are trained, they can determine the training requirements for other end users based on their specific roles.

Thermo Fisher Scientific’s Support Team offers scheduled trainings for many aspects of SampleManager LIMS Software, such as Data Configuration, LIMS Administration, Report Designer, Workflow Designer and so on. Training workshops can also be part of SampleManager LIMS Software implementation projects.

Also, Trainings for Users recordings help ensure a user is trained/qualified for a Preparation / Analysis Method or specific Instrument.

Does SampleManager LIMS Software support multiple levels of review and approval of a sample, such as peer, supervisor, and manager approval?

SampleManager LIMS Software is equipped with configurable inspection plans. An inspection plan is a list of personnel who must review and approve data before it is authorized. There are two types of inspection plan:

- Round Robin (parallel) Inspections allow the listed persons to inspect the data in any order.

- Linear (sequential) Inspections define the order in which the assigned personnel must inspect the data. Only when the first inspector has approved the data does it become available to the next person on the inspection plan.

All dynamic data (lots, jobs, samples, tests, results) have an authorization event. Authorization can have an electronic signature associated. When authorizing all child entities are also authorized. Authorized dynamic data is read-only and ready for reporting. Authorization functions can be executed by more than one user on one or more entities at a time.

Can Thermo Scientific SampleManager LIMS Software receive and process data from laboratory test machines and instruments through an API or an on-premises service/application that sends data to the LIMS system?

Simple instruments can be connected directly to a PC with the SampleManager LIMS Software client running, and can transfer their result directly to the SampleManager result entry box. For more complex instruments or instruments that require a controller software, the File Sweeper can be used.

SampleManager LIMS Software includes a lightweight file sweeper which provides a highly configurable interface for parsing data from instrument files and mapping it to the appropriate location within the software. Using the sweeper, instrument files can be interactively selected by a user or automatically imported into SampleManager Software via a background service.

The configuration process is straightforward, requiring only familiarity with the instrument's data format and eliminating the need for complex programming or extensive training. Users can map any instrument file to any data field within the LIMS, and the advanced data mapping and parsing capabilities enable interfaces with diverse instrument types from multiple vendors.

In addition, SampleManager LIMS Software 21.3 now supports Byte files such MS Excel, MS Word, and .Zip files, as well a PDFs with the sweeper functionality and parsing and mapping tools.

For complex integration tasks, Thermo Scientific Integration Manager is a flexible data transformation tool that delivers automated data acquisition and point to point data distribution across the enterprise. The system provides connectivity to all parts of the laboratory workflow, translating data generated by any of the instruments, services, or third-party enterprise applications that may be in place throughout the organization. Operating as an Integration Bus, Integration Manager provides a number of distributed connectivity agents to connect with various data source types. The agents send and receive data from systems. The transport is accomplished using XML streaming, thereby eliminating moving files from location to location. The Integration Manager transforms translate the varying data into an XML common object, which is used by IM to map and format the data to the receiving system requirements. This allows IM to interface with a wide variety of instruments and systems.