Seagreen-Bell Limited

Lab Information Management System Validation Service

We offer a range of validation services from retrospective for existing systems to replacement systems, based on the GAMP5 risk-based approach following the principles of the V-model. Packages tailored to meet individual customer requirements, light touch guidance to full document production and testing to support in-house experience. Digital Pathology Experts.

Features

• • Validation plan provided
• • System risk assessment report
• • User requirements specification
• • System configuration specification
• • Test strategy & plan
• • Full Testing & results. Installation, Operational, Performance Qualification. (IQ/OQ/PQ)
• • Validation traceability matrix
• • Quality assurance review
• • Validation summary report
• • Review of Standard Operating Procedures (SOPs)

Benefits

• • Experienced Consultants
• • Proven track record
• • Light touch support to full control options available
• • Best Practices – review the latest regulatory requirements
• Reduced validation time, full control can validate your systems quickly
• • Framework and SOPs available on request
• • Presentations undertaken to Trust Board, MHRA & UKAS
• MHRA, BCSH, RCPath, ISO15189, Annex 15, Annex 11 compliance

£680 to £1,010 a unit a day

Service documents

• Pricing document

  PDF

• Skills Framework for the Information Age rate card

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

Request an accessible format

If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at stephen@seagreen-bell.com. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 14

Service ID

521425887528169

Contact

Stephen Bell
+44 01825 890851
stephen@seagreen-bell.com

Planning

• Planning service: Yes
• How the planning service works: Through our comprehensive IM&T consultancy services we are able to support your requirements to achieve satisfactory accreditation or compliance, with regulatory bodies, such as MHRA, UKAS. We offer a range of validation services from retrospective for existing systems to replacement systems, based on the GAMP5 risk-based approach following the principles of the V-model. Packages can be tailored to meet individual customer requirements from light touch guidance to full document production and testing to support in-house experience. Our experienced professionals – working closely with your staff can help reduce costs and time to achieve the compliance necessary to the latest regulatory requirements. Working closely with quality and transfusion leads, we can support the planning and presentation of remedial action plans, if required or simply build a robust Validation framework to manage the process of CSV planning and testing to achieve thorough validation of your new or existing system
• Planning service works with specific services: No

Training

• Training service provided: Yes
• How the training service works: Inherent within our approach to validation delivery is our appreciation for the critical role of quality and validation within the lab. Full knowledge transfer will be provided to ensure continued compliance in to the future, with the help of SOPs, Validation framework documentation and shared resources produced during the assignments.
• Training is tied to specific services: No

Setup and migration

• Setup or migration service available: Yes
• How the setup or migration service works: Our service supports customer requirements to have thorough demonstrable computer system validation to meet all regulatory bodies.
• Setup or migration service is for specific cloud services: No

Quality assurance and performance testing

• Quality assurance and performance testing service: Yes
• How the quality assurance and performance testing works: We provide a full testing service either as part of a full lifecycle programme delivery or as a service that you can integrate into your existing cloud programme. Our team of testing and quality assurance professionals will be led by a dedicated experienced quality lead and will provide the following service: - Review and define testing and QA strategy based on current programme status - Resource, budget and technical requirements plan - Risk analysis and mitigation plan - Continuous delivery/integration processes with robust DevOps practices and Agile methodologies - Analysis of test automation benefits and implementation of automated test procedures where necessary - Training and knowledge transfer workshops, demonstrations and documentation - Define and generation of test governance documentation The testing we do can comprise of the following; -Performance Testing, -User Acceptance Testing, -Functional Testing -Load Testing/ Stress Testing/Capacity Testing, -Fail-over Testing, -Application Security Testing, -Risk Testing, -System Integration Testing. -Providing full & robust validation to meet MHRA, UKAS where necessary

Security testing

• Security services: Yes
• Security services type:
  • Security strategy
  • Security risk management
  • Security design
  • Security testing
  • Other
• Other security services:
  • Risk Analysis
  • IT Health Checks
  • Data Security and Protection Service ( DSPS Toolkit)
• Certified security testers: No

Ongoing support

• Ongoing support service: No

Service scope

• Service constraints: None

User support

• Email or online ticketing support: Email or online ticketing
• Support response times: Support response times; Within 24 hours - Monday - Friday (excluding public holidays) 09:00 - 17:00 Extra support outside of these hours can be provided at an additional cost
• User can manage status and priority of support tickets: No
• Phone support: Yes
• Phone support availability: 9 to 5 (UK time), Monday to Friday
• Web chat support: No
• Support levels: Support response times; Within 24 hours - Monday - Friday (excluding public holidays) 09:00 - 17:00 Extra support outside of these hours can be provided at an additional cost

Resellers

• Supplier type: Not a reseller

Staff security

• Staff security clearance: Other security clearance
• Government security clearance: None

Standards and certifications

• ISO/IEC 27001 certification: No
• ISO 28000:2007 certification: No
• CSA STAR certification: No
• PCI certification: No
• Cyber essentials: No
• Cyber essentials plus: No
• Other security certifications: No

Social Value

• Social Value:

  Social Value

  Fighting climate change

  Fighting climate change

  At the Seagreen-Bell Healthcare Consultancy we strive towards reducing our carbon impact by maintaining remote contact with clients and minimising travel.; We continue to facilitate change and system improvement through the use of workshops, virtual meetings and benchmarking service delivery by introducing best practice from our extensive experience working with similar clients from NHS Trusts around the country.

Pricing

• Price: £680 to £1,010 a unit a day
• Discount for educational organisations: No

Service documents

• Pricing document

  PDF

• Skills Framework for the Information Age rate card

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

Request an accessible format

If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at stephen@seagreen-bell.com. Tell them what format you need. It will help if you say what assistive technology you use.