IT governance & software assurance services
Take control of compliance and regulation to drive change based on actionable insights.
Our services enable and empower compliance professionals in regulated industries to simplify and automate complex GRC tasks. By mapping your policies and procedures, we help you align with regulatory obligations and achieve operational compliance.
With leading expertise in IT Governance/Assurance, US & EU GxP, HIPAA, HITECH, GDPR and NHS directive solutions, our compliance services help organisations navigate the complex regulatory landscape with ease.
Find out more about our compliance services
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Your benefits
Find out how Ideagen can help your organisation with operational compliance and regulations
Time and resource savings
Relieve the need for internal resource allocation or costs associated with outstanding validation work.
Comprehensive validation
We provide a complete and comprehensive validation document set.
Maintenance and longevity
Your validation status is maintained against any future system changes.
Compliance alignment
All your regulatory validation requirements are met and aligned.
End-to-end compliance services for the enterprise
Provide independent assurance of your platforms, while simultaneously accelerating the validation process, reducing time to production, and allaying validation costs.
We utilise transparent task management tools, virtual meetings, and remote whiteboarding capabilities to ensure our customers have full visibility and involvement as they take their journey along the compliance path.
Prospective or retrospective, our offering is presented in two phases
Our out-of-the-box validation provides all the required documentation pre-executed to the point of customer configuration on-site, saving you up to 8-10 weeks.
Our fast-track delivery service leverages the configuration material and our extensive solution knowledge to deliver a turnkey service for the remaining documentation, so you can achieve compliance more quickly and easily.
Our full range of IT governance & software assurance services:
Computer systems assurance and validation
Computer System Validation to cover all your GMP, GLP, GCP and QA/QC software applications.
ISO and SOC certification prep
ISO27001/ISO9001 and SOC2 support to deliver end-to-end controlled document and SOP set to meet certification requirements.
SaaS commercialisation
Get your software commercialised and make your operations align with regulatory requirements.
GDPR and privacy
Our privacy approach considers GDPR, HIPAA, and CCPA and boasts one of the largest CDPSE accredited teams in the industry.
Validation accelerator packages
A trusted validation acceleration partner for some of the biggest names in quality software.
Software as a medical device
We specialise in making sure that the inflection point where compliance meets quality is always at the heart of our project delivery.
IT governance and compliance
Services inclusive of Security Control Preparation/Audits/Training by our ISACA accredited CISA, CRISC, and CDPSE team.
HIPAA, HITRUST & EHNAC
Our single point governance program ensures that your policy and privacy frameworks can be harmonized to HIPAA, HITRUST, IEC62304, 21 CFR Part 820 and any area of health IT or life science convergence.
What solutions and platforms can we validate?
- Manufacturing Execution Systems (MES)
- Quality Management System (QMS)
- Maintenance Management Systems (MMS)
- Calibration Management Systems (CMS)
- Building Management Systems (BMS)
- Enterprise Resource Planning (ERP)
- Distributed Control Systems (DCS)
- SCADA Systems
- PLC Systems
- MS Excel Spreadsheet Validation
- Stability Systems
- DM and PK Systems
- Toxicology Systems
- Laboratory Robotics Systems
- Environmental Monitoring Systems (EMS)
- Chromatography Data Acquisition Systems
- Laboratory Information Management Systems (LIMS)
- Quality Management System (QMS)
- Lab Information Management Systems (LIMS)
- Quality Management System (QMS)
- Standalone applications for Laboratory Equipment
- Document Management Systems (DMS)
- GXP Training Tracking Systems
- SOP Systems
- CAPA Systems
- Case Report Form Systems
- Clinical Data Management Systems
- Statistical Analysis Software (e.g., SAS)
- Adverse Event Reporting Systems (AERS)
- Remote Data Entry/Remote Data Capture (RDE/RDC)
- Medical Monitoring
- Physician Management
- Study Communications
- Quality Management System (QMS)
The golden thread: achieve strategic objectives by risk-based compliance and oversight
Our white paper provides you with insights on addressing compliance challenges by taking a risk-based approach to corporate strategy.
Find out more about our compliance services and how we can help
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