SOLABS Level II Support – Frequently Asked Questions (FAQ)

1. What is Level II Support?

Level II Support is provided by SOLABS and includes:

• Detection and investigation of software defects
• Troubleshooting and issue analysis
• Providing workarounds or fixes
• Issuing corrective patches or updates
• Delivering new releases (minimum one per year)

Level II Support becomes available once your system goes live and continues throughout your active Support & Maintenance term.

2. What is the difference between Level I and Level II Support?

• Level I Support: Provided by the Customer (unless otherwise agreed). This includes basic user assistance and first-level troubleshooting.
• Level II Support: Provided by SOLABS. This includes deeper technical investigation, defect correction, and product-level fixes.

3. Who can contact SOLABS for Level II Support?

Customers must designate:

• 2 Authorized Level II Contacts
• A 3rd contact (optional) if the first two are not IT specialists

Only these authorized contacts may communicate incidents to SOLABS.

Customers must also provide:

• One distribution list email address for official support communications and weekly reports.

4. How do I contact SOLABS Support?

Standard Business Hours

Monday–Friday: 8:00 AM – 6:00 PM (EST)

• 📧 support@solabs.com
• 📞 514-287-1368 ext. 911
• 📞 1-877-322-1368 ext. 911

Emergency Hours (Urgent Issues Only)

Weekdays: 6:00–8:00 AM & 6:00–9:00 PM (EST)
Weekends & Statutory Holidays: 9:00 AM – 5:00 PM (EST)

• 📧 support@solabs.com

Statutory Holidays:

• New Year’s Day
• Labor Day (1st Monday of September)
• Thanksgiving / Columbus Day (2nd Monday of October)
• Christmas Day
• Outside of Standard & Emergency hours📧 support@solabs.com & call 1-877-322-1368 ext. 911

Urgent requests, when submitted prior to the start of current day business hours will be treated the same day. However, urgent requests submitted after  the current  day business hours will be treated the following day – unless specified otherwise in your license and support agreement.

5. What qualifies as a “State of Emergency”?

A State of Emergency is defined as:

• Complete loss of system functionality
• Infrastructure damage
• Virus or severe system degradation
• Total production outage

In confirmed emergencies:

• Head of Engineering is notified
• CEO is notified
• SOLABS coordinates immediate restoration efforts

Emergency calls are evaluated within 20 minutes during normal operating hours.

6. What systems and versions are supported?

Software Support

• Current release
• Previous minor release only

If your system is more than 1 minor release behind, you must upgrade before issues will be addressed.

Supported Browsers

• Google Chrome
• Microsoft Edge
• Mozilla Firefox

7. What authentication methods are supported?

Production Environments

• SOLABS Identity
• Azure Active Directory (SSO)
• OneLogin (SSO)

⚠ Database login is not supported for Production environments.

Validation Environments

• Hosted Read-Only configuration
• Database login only
• No SOLABS Identity or SSO support

8. What types of issues can be reported?

Core Software Issues

Issues related to:

• Document Control
• Training
• Tasks
• Setup
• Standard reports & datasets

QM APP Issues

Issues related to:

• CAPA
• Change Control
• Deviation
• Laboratory Investigations
• Complaints
• Other non-core processes

9. How are issues categorized?

Issues are classified by Criticality Level:

10. What are the response times?

Urgent Issues

• CREQ initiated: 8 hours (includes emergency hours)
• Investigation/Answer: 8 business hours
• Temporary fix: 2 business days
• Permanent fix: Included in upcoming release (prioritized via risk-based Lean Kanban framework)

Major Issues

• CREQ initiated: 8 business hours
• Investigation/Answer: 2–3 business days
• Temporary fix: 5 business days

Moderate Issues

• CREQ initiated: 2 business days
• Investigation: 15 business days
• Resolution timeline:
  • Hosted: 20 business days
  • On-prem (legacy): 30 business days

Fixes are prioritized using SOLABS’ Lean Kanban framework based on:

• Client satisfaction
• Regulatory impact
• Security & data integrity
• Market impact
• Technology risk

11. What is a CREQ?

CREQ = Customer Request

• Created when an issue is confirmed
• Tracked through investigation and resolution
• May generate an Investigation Report (IR)
• Weekly CREQ report sent to customer distribution list

12. What is a Temporary Solution (Intervention)?

A temporary solution:

• Is scheduled with the client
• May require system access
• Is tested and deployed by SOLABS
• Can be rescheduled if needed
• Must be confirmed by the client

If access is not provided at the scheduled time, intervention is canceled and rescheduled.

13. What is a Permanent Solution?

A permanent solution is delivered in a new release.

SOLABS provides at least one major or minor release per year, plus patches as needed.

14. How are upgrades scheduled?

Validation Environment

• Automatically scheduled by SOLABS
• Minimum 10-day advance notice
• No client approval required

Production Environment

• Scheduled with client
• Written confirmation required
• Clients book preferred date/time

Upgrades follow SOLABS Work Instructions for scheduling.

15. What is the system uptime guarantee?

Hosting SLA guarantees:

• 99.75% uptime
• Outage resolution within 8 hours

If uptime falls below guarantee:

• Client receives 5% service credit on next annual base fee

Scheduled maintenance is excluded.

16. How often is maintenance performed?

Scheduled maintenance:

• At least 3 times per year
• 72-hour advance notice
• Performed outside 8 AM – 8 PM EST (Mon–Fri)

17. How are backups managed?

Backup Schedule:

• Full backup: Weekly (retained 30 days)
• Differential backup: Daily (30 days)
• Transactional backup: Hourly (7 days)

Backups stored at:

• Two locations without need for human intervention
  • Iron Mountain guarantees access to the data

Recovery timelines:

• System recovery: 8 hours
• Worst-case disaster recovery: 120 hours
• Maximum data loss exposure:
  • Server failure: 1 hour
  • Force majeure: 24 hours

18. How are security and hosting managed?

• Hosting provided via Iron Mountain Data Centers
• 24/7 availability
• Managed under SOP000006 (Data Center Controls and Monitoring)
• Infrastructure changes require ticketing and tracking

19. How are service requests handled?

Once requirements are:

• Communicated
• Assessed
• Approved

SOLABS will provide a fulfillment timeframe.

20. What happens during a regulatory audit?

• Clients should notify SOLABS once an audit date is confirmed.
• Requests submitted during a regulatory audit will then be treated as a priority.