Biotechnology, Life Sciences, and Research Organizations

Managed IT and Cybersecurity for Life Sciences.

Fit: life-sciences teams supporting laboratory, business, and electronic-record workflows. Scope: managed IT, cybersecurity, backup, and recovery for agreed systems.

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Built for organizations like yours

Biotechnology company, life sciences organization, or research laboratory

Development-stage or growth-stage life sciences company

Laboratory team operating specialized scientific applications and instruments

Organization maintaining electronic laboratory or quality records

Company using cloud-based laboratory, quality, or research platforms

Organization with computers directly connected to laboratory instruments or scientific equipment

Teams accessing data acquisition systems, electronic lab notebooks, or laboratory information systems

Organization without a dedicated internal IT or cybersecurity team supporting laboratory and business environments

Organization whose systems may require evaluation for FDA regulatory or 21 CFR Part 11 applicability

Research or quality environment where technology availability directly affects scientific work

How Your Business Actually Works

Technology Is Part of the Laboratory Workflow

Life sciences work depends on technology at every stage of the laboratory and quality workflow. Scientific staff use instruments connected to dedicated workstations, specialized data-acquisition software, electronic lab notebooks, laboratory information systems, and quality management platforms — all alongside Microsoft 365, email, cloud applications, and shared file storage. A laboratory workflow may move from experiment setup through instrument operation, data acquisition, electronic record capture, analysis, documentation, quality review where applicable, storage, retention, and recovery. Technology participates at each step, and a failure at any point in that chain reaches the work depending on it. Laboratory computers connected directly to instruments create a distinct category of IT consideration. These systems may depend on specific operating-system versions, vendor-approved configurations, or proprietary interfaces that limit when and how normal IT changes can be applied. Network changes can affect instrument communication. Security controls must account for operational compatibility before being applied. This is not an obstacle to managing these systems — it is a reason to manage them with awareness of how they are actually used.

Instrument operation and data acquisition on laboratory-connected workstations and control software

Electronic record capture across ELN, LIMS, and scientific applications

Data analysis, review, and reporting through scientific and quality platforms

Quality-system documentation and workflows where applicable to the organization's activities

Microsoft 365 email, collaboration, and document management for laboratory and business staff

Cloud-based scientific, quality, and business application access from laboratory and remote environments

Data storage and retention across laboratory systems, file repositories, and cloud platforms

Backup, recovery, and business continuity planning across laboratory and business technology

The Business Reality

Technology Problems Life Sciences Teams Recognize Immediately

Life sciences organizations depend on specialized technology that does not behave like a standard office environment. When that technology fails, the disruption reaches laboratory workflows, quality processes, and scientific work — not just administrative operations.

An instrument computer fails during critical laboratory work

An instrument-connected workstation failure or scientific application outage can interrupt experiments, testing, or data acquisition in progress. Depending on the nature of the failure and the work underway, the impact may include lost productivity, repeated work, delayed analysis, unplanned vendor escalation, and potential data-recovery requirements. Instruments that require specific workstation configurations for operation cannot simply be moved to another computer. The faster the issue is diagnosed and the appropriate vendor engaged, the smaller the disruption.

Scientific and research data exists across multiple systems

Laboratory and scientific information may exist simultaneously across instrument computers, scientific applications, ELN and LIMS platforms, quality systems, Microsoft 365, file repositories, cloud applications, and local workstation storage. Without a current technology and data inventory, organizations may not know where critical information resides, who can access it, whether it is backed up, which vendor controls it, or how it would be recovered following a failure. Data spread across systems that are not inventoried is data that may not be recoverable.

Legacy and vendor-restricted systems create security and management challenges

Scientific instruments and specialized applications frequently depend on specific operating-system versions, vendor-approved software configurations, proprietary interfaces, or hardware drivers that affect how and when IT changes can be applied. Security patching, software updates, and endpoint protection deployment sometimes require coordination with the instrument or software vendor before they can be applied to these systems. Edge Secure coordinates security and technology changes with system owners and vendors where compatibility requirements apply, rather than applying changes without regard for operational consequences.

User access and system changes require consistent procedures

Employee hiring, role changes, departures, and administrative-access management all affect Microsoft 365 accounts, scientific applications, cloud platforms, shared laboratory systems, and vendor-supported technology. Consistent, documented access-management procedures reduce the risk of unauthorized access after role changes or departures. In environments operating systems that support electronic records or quality workflows, access and change management may also support the organization's broader quality and compliance processes. Edge Secure manages the IT side of access and change procedures — the organization's quality and compliance professionals remain responsible for determining regulatory applicability.

A cybersecurity incident can become a laboratory operations problem

Ransomware, compromised credentials, unavailable networks, or endpoint compromise do not affect administrative systems in isolation. Scientific and laboratory operations depend on the same identity infrastructure, network connectivity, endpoint health, cloud services, and storage environments as the rest of the organization. A cybersecurity event affecting those shared resources can disrupt instrument access, application availability, electronic record systems, and laboratory workflows simultaneously. Cybersecurity therefore supports operational continuity as well as information protection.

Your backup says successful — but can the laboratory actually recover?

A successful backup status notification confirms the job ran. It does not confirm that scientific data can be restored, that instrument-related data is included in coverage, that application dependencies are understood, that recovery procedures are documented, that SaaS-based laboratory or quality data is independently recoverable, or that critical systems can be restored in the correct sequence following a disruption. Restore validation, recovery-priority documentation, system-dependency mapping, and documented vendor escalation paths address what backup status notifications alone cannot.

What Edge Secure Handles

What Edge Secure Takes Off Your Plate

Laboratory, scientific, quality, and company leadership should not have to determine whether a workstation is secure, whether critical data is protected, whether a departing employee still has access, or which technology vendor to contact when a specialized system stops working. Edge Secure manages the supporting technology environment while coordinating appropriately with scientific application and instrument vendors.

IT Support

Help desk for laboratory, quality, scientific, and administrative staff
Remote support under managed agreements
Workstation and application troubleshooting
Microsoft 365 support and management
Instrument-connected workstation support where appropriate
Coordination with laboratory application and equipment vendors
Appropriate priority handling for business-critical technology issues

Endpoint & Laboratory Workstation Management

Standard workstation and laptop monitoring and management
Instrument-connected workstation management where appropriate
Operating-system and application patching where compatible with vendor requirements
Endpoint configuration and security controls appropriate to the system
Hardware health monitoring and lifecycle planning
Vendor compatibility considerations for scientific and instrument systems

Microsoft 365 & Identity

Exchange Online, SharePoint, OneDrive, and Teams management
Account setup and lifecycle management
MFA on supported user and administrative accounts
Identity and sign-in activity monitoring
Administrative-account protection and privileged-access controls

Cybersecurity

Endpoint protection on managed systems
Email security with phishing and BEC-focused controls
Identity monitoring and suspicious-activity response
Vulnerability management and patch-status oversight
Security-event monitoring and alert response
Security configuration coordinated with system owners for specialized laboratory systems

Backup, Recovery & Continuity

Encrypted backup of research data, quality records, and business systems
Microsoft 365 email, SharePoint, and OneDrive backup
Server and workload backup where applicable
Scientific and laboratory data backup where technically supported and vendor-permitted
SaaS application backup where vendor capabilities and data access permit
Appropriate immutable or ransomware-resistant backup copies
Backup monitoring and restore validation
Documented disaster recovery procedures and recovery priorities
Business continuity planning appropriate to the engagement

User Lifecycle, Access & Documentation

New-user account setup with appropriate role and access assignment
Access adjustments for role changes
Prompt offboarding across email, applications, and shared systems
Administrative and shared account review
Access documentation and managed-system inventory
Technology-dependency documentation
Consistent lifecycle procedures supporting internal governance
Technical records that may support broader quality and compliance processes where applicable

Why Edge Secure

Why Life Sciences Organizations Choose Edge Secure

One Partner for IT and Cybersecurity

Help desk, Microsoft 365, identity management, cybersecurity, laboratory and standard endpoints, backup, recovery, and vendor coordination are managed as parts of one technology relationship. When something goes wrong, there is one call — not separate providers for laboratory IT, business IT, and cybersecurity.

Scientific Technology Is Not Treated Like an Office PC

Instrument-connected workstations and specialized scientific applications may depend on specific operating-system versions, drivers, vendor-approved configurations, local databases, proprietary interfaces, and controlled change processes. Edge Secure evaluates technology and security changes in the context of each system's purpose, vendor requirements, operational dependencies, and any applicable change-control considerations. A laboratory workstation may require a different management approach than a standard office computer — and that difference is accounted for, not ignored.

Vendor Coordination Across the Laboratory Technology Environment

When a problem involves a laboratory application, instrument-connected computer, scientific software, ELN, LIMS, QMS, Microsoft 365, or cloud environment, Edge Secure helps determine whether the issue is related to the workstation, operating system, network, identity, security configuration, or the application or vendor-controlled system. When specialized vendor assistance is required, Edge Secure coordinates directly with the appropriate provider. Edge Secure has experience supporting technology used in Life Sciences environments, including Labguru, DotCompliance, NC-203 cell counter environments, ID5 plate reader environments, and SoftMax Pro. You call Edge Secure first.

Technical Controls and Documentation You Can Use

Edge Secure maintains documentation of the applicable technical controls it manages, including user and device inventories, MFA status, identity protections, endpoint-security coverage, email-security configuration, backup status, restore-validation records, recovery procedures, vendor dependencies, and access documentation. These records may support internal governance, quality processes, cyber insurance, vendor assessments, system reviews, and regulatory or compliance activities where applicable. They do not validate a computerized system, establish Part 11 compliance, replace validation documentation or SOPs, or substitute for Quality approval.

Your Scientists and Quality Teams Shouldn't Have to Manage Their IT Company

Edge Secure can review your IT, laboratory technology, Microsoft 365, identity security, cybersecurity, backup, recovery, and critical technology dependencies to identify areas that may create operational or security risk.

Schedule a Life Sciences IT & Cybersecurity Assessment

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Electronic Records & Regulated Systems

Technology Supporting Electronic Records & Regulated Systems

Life Sciences environments may include scientific applications, laboratory instruments, quality systems, electronic records, and specialized computers that require more deliberate technology management than standard office systems. Where systems support regulated electronic records or signatures, applicable technical controls may form part of the organization's broader quality, validation, and compliance program. Edge Secure manages applicable technology and cybersecurity controls surrounding these systems. The organization retains responsibility for regulatory applicability, intended use, validation requirements, Quality approval, SOPs, and formal compliance decisions.

Identity & Access Controls

Unique user accounts where technically supported
MFA where supported and appropriate
Administrative-account protection and privileged-access review
Role-appropriate access assignment
User lifecycle management and prompt access removal
Shared and service-account review
Access documentation supporting internal governance
Technical access records that may support broader regulated-system requirements where applicable

Controlled Technology Changes

Technology changes evaluated for compatibility before deployment
Operating-system, application, security, driver, and configuration changes coordinated with system owners
Coordination with Quality personnel, application vendors, and instrument vendors where applicable
Network, database, hardware, and identity changes assessed for operational impact
Organization retains responsibility for determining change-control, testing, revalidation, and Quality-approval requirements
Edge Secure does not independently determine validation obligations or change-control scope

Logging, Audit Trails & Technical Records

Operating-system and security logs on managed systems
Identity and sign-in activity logs
Administrative-activity and backup logs
Network and security-event monitoring records
Log retention appropriate to managed-system scope
Centralized security monitoring where supported
Application audit trails remain the responsibility of the application vendor and system owner — Edge Secure supports surrounding infrastructure, security logging, access controls, and technical monitoring within the managed environment

System Time & Technical Consistency

Consistent time synchronization managed for supported systems
Supports accurate security logs, authentication records, backup records, and system events
Aids incident investigation and technical record interpretation
Time synchronization does not independently establish compliant timestamps or Part 11 compliance

Protecting Scientific & Operational Data

Access controls limiting data exposure to authorized users
Endpoint protection on managed workstations
Network security for laboratory and business environments
Backup where technically supported and vendor-permitted
Security monitoring and alert response
Vendor coordination for data stored in third-party and SaaS platforms
Recovery planning for applicable data environments
Edge Secure helps identify technical data locations and available protection methods within the scope of the engagement

Edge Secure manages applicable IT, cybersecurity, infrastructure, backup, recovery, logging, and technical controls surrounding scientific and laboratory systems. The Life Sciences organization remains responsible for intended use, regulatory applicability, validation requirements, audit-trail requirements, record-retention requirements, Quality approval, SOPs, and formal compliance decisions.

Operational Resilience

Backup, Disaster Recovery & Business Continuity

Life Sciences organizations depend on scientific applications, laboratory systems, electronic records, Microsoft 365, and business operations that must be recoverable after disruption. Recovery planning must account for both standard business systems and the specialized technology dependencies unique to laboratory and quality environments.

Backups protect the data — Disaster Recovery restores the technology — Business Continuity keeps the business operating.

Backup

Backup strategy is determined by where scientific and operational data resides and what each system technically supports. Coverage is not assumed to apply equally to every system — it is determined by system architecture, vendor capabilities, and accessible data locations.

Microsoft 365 email, SharePoint, and OneDrive backup
Business files and network storage backup
Server and applicable workload backup
Instrument-workstation data backup where technically supported and appropriate
Scientific-application data backup where supported by the application and vendor
SaaS application backup where vendor capabilities and data access permit
Encrypted backup with appropriate retention
Appropriate immutable or ransomware-resistant backup copies
Backup monitoring, alert response, and failure remediation
Periodic restore validation confirming actual recoverability

Disaster Recovery

Disaster Recovery addresses restoring critical technology and access following a significant disruption. For vendor-controlled scientific systems, recovery may require coordination with the instrument or application vendor rather than Edge Secure independently restoring the system. Recovery targets are tied to business requirements and the applicable service plan.

Critical-system identification and technology-dependency mapping
Recovery priorities including laboratory applications, instrument workstations, Microsoft 365, storage, and network infrastructure
Documented recovery procedures for managed systems
Vendor-dependency documentation for scientific applications, SaaS platforms, and instrument systems
Recovery targets (RTO/RPO) based on business requirements and applicable service plan
Restore validation and procedure updates as technology changes
Coordination with application and instrument vendors where vendor-led recovery is required

Business Continuity

Business Continuity addresses how critical scientific, quality, and operational activities can continue while technology recovery proceeds. Edge Secure helps develop and maintain the technology and recovery components supporting the organization's broader business continuity planning. Where validated systems are involved, restoration may also require the organization to follow applicable SOPs, change-control procedures, and Quality-approval processes — Edge Secure performs applicable technical recovery but does not independently determine fitness for return to regulated use.

Identification of critical scientific, quality, and business operations
Minimum technology requirements for critical activities
Vendor and SaaS dependency planning
Alternative-procedure documentation
Communication requirements during a disruption
Coordination with Disaster Recovery priorities and timelines
Continuity scenarios including instrument workstation failure, laboratory application outage, SaaS outage, network failure, Microsoft 365 outage, storage failure, and cybersecurity incidents

Ongoing Management

What We Monitor and Manage

The service section above describes what Edge Secure takes responsibility for. This section describes what Edge Secure actively monitors and manages following onboarding.

Workstations & Laboratory Computers

Managed-device hardware health and status
Operating-system patch and update status where appropriate
Application availability and status where supported
Endpoint-security protection status
Instrument-connected workstation status where within managed scope
Hardware lifecycle and replacement planning

Microsoft 365 & Identity

Exchange Online and email security status
Sign-in activity monitoring and identity alerts
MFA status on supported accounts
Administrative-account security
SharePoint and OneDrive security monitoring where applicable
Account lifecycle events

Cybersecurity

Endpoint-security alerts and event response
Security-event monitoring across managed systems
Identity and account-activity alerts
Vulnerability and patch-status oversight
Security-configuration review appropriate to managed systems
Security changes coordinated with system owners for vendor-restricted laboratory systems

Backup & Recovery

Microsoft 365 backup completion and status
Server and workload backup status where applicable
Scientific-data backup status where within managed scope
Backup alerts and failure response
Restore-validation status and recovery-readiness documentation

Network & Connectivity

Office and laboratory network health and availability
Firewall status and configuration
Wi-Fi availability and performance
Internet connectivity monitoring
Secure remote-access monitoring
Network dependencies supporting managed scientific and business systems

Industry-Specific Risk

How Cybersecurity Threats Affect Life Sciences Environments

Credential and Identity Compromise

Compromised credentials may provide unauthorized access to Microsoft 365, scientific applications, cloud platforms, laboratory systems, quality systems, file repositories, and other connected resources. Identity compromise in a Life Sciences environment can expose research data, electronic records, quality documentation, and proprietary scientific information across interconnected platforms. MFA on supported accounts, identity monitoring, administrative-account protection, role-appropriate access controls, and prompt user lifecycle management reduce but do not eliminate this risk.

Ransomware and Endpoint Compromise

Ransomware or endpoint compromise can affect laboratory workstations, scientific computers, file servers, shared storage, Microsoft 365, and supporting infrastructure — not only office productivity systems. Instrument-connected computers may require carefully selected cybersecurity controls because vendor compatibility requirements can limit ordinary endpoint-management approaches. The appropriate security posture for a laboratory workstation should be determined in the context of each system's operational requirements, not assumed identical to a standard office computer.

Scientific Data Loss or Unauthorized Modification

Scientific and operational data may exist across instrument workstations, scientific applications, ELN and LIMS platforms, quality systems, Microsoft 365, file repositories, and cloud services. Cybersecurity controls can help reduce risks from unauthorized access, accidental deletion, malicious modification, ransomware, compromised credentials, and inappropriate administrative access. These controls do not independently establish scientific data integrity or regulatory compliance — that determination depends on organizational procedures, validation, intended use, and applicable quality and regulatory requirements.

Vendor and SaaS Dependency Risk

Life Sciences organizations may depend on ELN and LIMS providers, QMS platforms, scientific SaaS applications, instrument vendors, cloud services, Microsoft 365, and specialized software vendors. A security or availability event affecting a provider can create operational risk even when the organization's own technology environment is functioning normally. Edge Secure can help document vendor dependencies, access relationships, vendor contacts, escalation procedures, and technology-recovery considerations. Edge Secure does not control the security posture of third-party vendors or SaaS providers.

Regulatory Considerations

FDA 21 CFR Part 11 & Electronic Records

Some Life Sciences systems may create, modify, maintain, archive, retrieve, or transmit electronic records required by FDA predicate rules, or may be used in place of required paper records. Where applicable, FDA 21 CFR Part 11 establishes requirements relating to electronic records and electronic signatures. Part 11 applicability is not determined by the type of technology used. Applicability depends on the specific record, the applicable predicate rules, the intended use of the system, whether the electronic record is relied upon to perform regulated activities, and the organization's specific circumstances. Organizations should document their applicability determination with appropriate Quality and regulatory involvement.

Part 11: Electronic Records and Electronic Signatures

21 CFR Part 11 addresses requirements for qualifying electronic records and electronic signatures within its scope. Technology controls can support applicable requirements, but Part 11 is not a general cybersecurity framework and is not equivalent to NIST, CIS Controls, SOC 2, or general cybersecurity programs. Cybersecurity controls may support the confidentiality, integrity, availability, access control, monitoring, and resilience of systems containing regulated records — but cybersecurity programs and Part 11 applicability assessments address different questions and should be managed separately.

Electronic Records

Organizations should understand what electronic records are created, where they reside, which systems create or modify them, who can access them, how they are retained, how they are backed up, how they would be recovered, and which systems fall within the organization's regulated scope. Edge Secure can assist with technical inventory, infrastructure documentation, access controls, backup and recovery, security monitoring, and logging within its service scope. The organization remains responsible for determining which records are regulatory records and what retention, quality, and record-management requirements apply.

Electronic Signatures

Where electronic signatures are used within applicable regulated processes, Part 11 includes requirements addressing signature controls, linking, and associated records. Edge Secure may support surrounding technical controls including identity management, account security, authentication infrastructure, access management, endpoint security, and system availability. Edge Secure does not determine whether a specific signature process satisfies Part 11 requirements unless separately engaged for an appropriate assessment. An ordinary e-signature application is not automatically equivalent to a Part 11-compliant electronic signature implementation.

Audit Trails

Applications supporting regulated records may provide application-level audit-trail capabilities that record applicable changes or activities within the application. These are distinct from Windows event logs, firewall logs, identity and sign-in logs, security-monitoring records, endpoint-security logs, and backup logs. Edge Secure can manage applicable cybersecurity and infrastructure logging surrounding managed systems. The application's audit-trail functionality depends on the application's capabilities, configuration, intended use, and the system owner's quality requirements. Security and infrastructure logging does not replace an application's required audit trail.

Computerized System Validation

Systems used in regulated activities may require validation appropriate to their intended use and applicable regulatory requirements. The Life Sciences organization remains responsible for intended use, user requirements, validation strategy, risk assessment, acceptance criteria, test approval, Quality approval, final validation determination, change-control decisions, and revalidation decisions. Edge Secure may support the technical side of validation activities where appropriate — including system inventory, infrastructure documentation, configuration documentation, access-control implementation, backup and recovery configuration, and technical evidence collection. Edge Secure does not independently validate systems.

Data Integrity

Scientific and regulated data integrity is broader than cybersecurity alone. Relevant technical controls Edge Secure can manage include appropriate access controls, unique user identities where supported, administrative-account management, backup and recovery, system time synchronization, change coordination, security monitoring, and protection against unauthorized modification. Data integrity also depends on scientific processes, quality procedures, system configuration, intended use, user practices, validation, record review, and organizational controls. Edge Secure manages applicable technical controls but does not independently certify scientific or regulatory data integrity.

Instrument-Generated Electronic Data

A laboratory instrument may generate electronic results through a connected workstation or scientific application. If the organization relies on those electronic records to satisfy an applicable FDA record requirement, the system and workflow may require evaluation for Part 11 applicability. If the electronic information is not a required regulatory record and is not being used in place of a required paper record, the applicability analysis may be different. The determination should be made by the organization with appropriate Quality and regulatory involvement. The instrument itself is not automatically subject to Part 11 based solely on its hardware type.

Vendor and SaaS Systems

Using a cloud application or vendor-hosted scientific or quality platform does not eliminate the organization's responsibility to understand intended use, data ownership, access controls, security practices, backup and recovery capabilities, record retention, vendor responsibilities, system changes, and applicable validation and compliance requirements. Edge Secure can help assess and document the technology and cybersecurity aspects of vendor systems within the scope of the engagement. Complete regulatory vendor qualification for Part 11 or validation purposes requires appropriate Quality and regulatory engagement beyond Edge Secure's standard managed IT and cybersecurity scope.

Cyber Insurance

Cyber insurance applications and policies may request information regarding MFA, endpoint security, backup, immutable backup copies, email security, security monitoring, incident-response procedures, vulnerability management, privileged-access controls, and recovery procedures. Requirements vary by carrier and policy. Edge Secure can implement and document applicable technical controls it manages. Edge Secure does not determine insurance coverage, interpret policies, guarantee underwriting approval, or guarantee claim eligibility.

Edge Secure supports the technology and cybersecurity components surrounding Life Sciences systems. Regulatory applicability, intended use, predicate-rule requirements, computerized system validation, electronic-record and electronic-signature requirements, Quality approval, SOPs, record-retention requirements, and formal compliance decisions remain the responsibility of the Life Sciences organization and its qualified Quality, regulatory, legal, and compliance professionals. This section provides general technology and cybersecurity information only and does not constitute legal, regulatory, validation, Quality, scientific, or compliance advice. Requirements depend on the organization's activities, systems, records, intended use, predicate rules, and specific circumstances.

Technology Environment

Technology Your Life Sciences Organization Depends On

Life Sciences environments often combine standard business technology with specialized laboratory applications, scientific software, instrument-connected workstations, quality systems, cloud platforms, and vendor-supported equipment. Edge Secure supports the surrounding technology environment and takes a best-effort approach to learning and supporting the applications and systems each organization depends on. When specialized scientific application or instrument assistance is required, Edge Secure coordinates with the appropriate software or equipment vendor. Edge Secure has experience supporting technology used in Life Sciences environments, including Labguru, DotCompliance, NC-203 cell counter environments, ID5 plate reader environments, and SoftMax Pro.

Laboratory & Scientific Applications

LabguruElectronic lab notebook platformsLaboratory record and collaboration toolsSample and inventory management applicationsCloud-based laboratory platforms

Edge Secure has experience supporting Labguru and similar laboratory application environments, including the surrounding endpoint, browser, network, identity, security, access, and vendor-coordination environment. Labguru partnership, vendor certification, and validation authority are not claimed. Whether a specific Labguru implementation is subject to Part 11 or validation requirements depends on the organization's intended use and regulatory circumstances.

Quality Management Systems

DotComplianceQuality documentation and workflow platformsControlled-process management systemsRecord and deviation managementCloud-based quality platforms

Edge Secure has experience supporting DotCompliance and similar quality platform environments, including surrounding identity, endpoint, network, access, security, and Microsoft 365 environments. Where regulatory or validation requirements apply, the organization remains responsible for intended use, validation, Quality approval, configuration approval, and regulatory applicability. DotCompliance partnership or certification is not claimed.

Laboratory Instruments & Connected Workstations

NC-203 cell counter environmentsID5 plate reader environmentsInstrument-connected workstationsData-acquisition computersScientific hardware support environments

Edge Secure supports the technology environment surrounding laboratory instruments — including connected workstations, operating systems, network connectivity, user access, security configuration, data storage, and vendor coordination. Edge Secure does not repair instruments, calibrate equipment, certify scientific accuracy, perform scientific qualification, or replace manufacturer support. When an issue involves instrument hardware, scientific operation, or proprietary vendor functionality, Edge Secure coordinates with the appropriate manufacturer or vendor.

Scientific Data & Analysis Software

SoftMax ProInstrument control and data-analysis softwareScientific data platformsLocal and network data storage for scientific applicationsVendor-supported workstation configurations

Edge Secure supports the surrounding technology environment for scientific software — workstation health, operating-system compatibility, network connectivity, user access, storage, backup where supported, and vendor coordination. SoftMax Pro partnership, certification, and validation authority are not claimed. Whether a specific SoftMax Pro environment is subject to Part 11 depends on the organization's intended use, predicate rules, and regulatory circumstances.

Microsoft 365 & Collaboration

Exchange Online and OutlookSharePointOneDriveTeamsBusiness identity and access managementMicrosoft 365 security configuration

Data, Storage & Backup

Network-attached storageLocal application and instrument-workstation dataScientific data repositoriesMicrosoft 365 dataCloud storage and SaaS platform dataApplicable server storage

The appropriate backup method depends on where data resides, application architecture, vendor capabilities, API access, database architecture, and export capabilities. Not every data source supports the same backup approach. Retention requirements are determined by the organization.

Laboratory & Business Devices

Standard Windows workstations and laptopsInstrument-connected computersAppropriate mobile devicesLaboratory peripheralsLabel printers and scannersOther supported endpoint technology

Network & Connectivity

Laboratory and office networksFirewalls and internet connectivityWi-FiSecure remote accessAppropriate network segmentationInstrument and application network dependenciesCloud connectivity

Laboratory network changes may require consideration of instrument communication and vendor requirements before implementation. Edge Secure coordinates applicable changes with system owners and vendors where operational dependencies apply.

Getting Started

What the First 30 Days Can Look Like

Transitioning to a new IT and security partner should reduce stress, not create it. Edge Secure follows a structured onboarding process that builds understanding before making changes.

Discover

Build a complete picture of the environment before making changes.

User and account inventory across managed systems
Standard device and laptop inventory
Instrument-connected workstation identification
Microsoft 365 and identity review
Administrative and privileged-account review
Laboratory application and scientific-software inventory
Quality-system identification
Critical vendor and escalation-contact identification
Data-location identification across laboratory, business, and cloud systems
Network-dependency review
Existing backup-system review
Recovery-priority identification
Existing cybersecurity-control review
Systems identified by the organization as requiring regulatory or validation consideration documented accordingly

Secure

Address the highest-priority technology and cybersecurity gaps while respecting system compatibility and applicable change requirements.

MFA on supported user and administrative accounts
Email-authentication configuration review
Endpoint protection on managed systems where compatible
Administrative-account and privileged-access review
Shared and service-account review
Remote-access security review
Immediate vulnerability and security-gap remediation
Appropriate network and security controls
For laboratory or validated systems: changes coordinated with system owners and vendors with consideration for compatibility, change-control requirements, and validation impact where applicable

Stabilize

Resolve existing technology problems and establish reliable managed operations.

Standard workstation and application issues
Instrument-workstation issues within scope
Microsoft 365 and identity access issues
Application-access and network/connectivity problems
Backup-failure remediation
Initial restore validation
Immediate recovery-gap identification
Vendor escalation paths documented
Help-desk procedures established for laboratory and business staff
Scientific application or instrument issues requiring vendor involvement coordinated accordingly

Document

Build the technical records that support consistent, documented, and recoverable technology operations.

User and account inventory
Standard and instrument-connected device inventory
Application and system inventory
Vendor and technical-contact inventory
Access and administrative-account documentation
Data-location and technology-dependency documentation
Backup procedures and coverage documentation
Recovery priorities and documented recovery procedures
Disaster-recovery and business-continuity technology dependencies
Applicable technical-control documentation
Technical records organized to support internal governance, quality processes, or compliance activities where applicable — these do not replace Quality-system documentation

Ongoing

Keep technology, security, access, recovery readiness, vendor dependencies, and documentation current as the organization changes.

Proactive monitoring of managed devices and systems
Managed-device and operating-system maintenance
User lifecycle management and access updates
Microsoft 365 and identity management
Security-event monitoring and response
Backup monitoring and periodic restore validation
Recovery-readiness and documentation review
Vendor coordination as applications and systems change
Change coordination for applicable laboratory systems with system owners and vendors
Technology planning support

Relevant Services

Service

Primary source: FDA Part 11 guidance

Electronic records, predicate rules, and scope

Service

Managed IT Services

IT support, Microsoft 365 management, laboratory and business workstation support, application troubleshooting, and vendor coordination for Life Sciences environments.

Service

Cybersecurity & MSSP

Identity security, email protection, endpoint security, vulnerability management, monitoring, and incident-response support across business and applicable laboratory technology environments.

Service

Backup & Business Continuity

Microsoft 365 and applicable scientific/workload backup, restore validation, disaster recovery planning, and technology-focused business continuity support.

Self-Assessment

See Where Your Life Sciences Environment May Have Technology or Security Gaps

Not ready to schedule a conversation? Start with a self-assessment designed to identify potential gaps in cybersecurity, IT management, backup, and recovery practices across your business and technology environment.

Life Sciences Cybersecurity Assessment →Managed IT Readiness Assessment →Backup & Recovery Readiness Assessment →

Common Questions

Questions from Life Sciences Businesses

Next Step

Ready to Take IT and Cybersecurity Off Your Team's Plate?

Let's review the technology supporting your laboratory, scientific applications, electronic data, Microsoft 365, cybersecurity, backup, and recovery environment and identify where technology or security gaps may put operations at risk.

Schedule a Life Sciences IT & Cybersecurity Assessment

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