What We Do

Extensive assistance in aligning your business with regulations: ISO 27001, ISO 13485, ISO 42001, SOC II Type 2, GxP: GAMP 5, ASPICE, GDPR, NIS2, EU AI Act, etc. We offer complete guidance, from readiness assessment & strategy creation to necessary components, processes & procedures implementation.

What You Get

Understanding of your existing compliance posture, a list of steps needed to meet regulatory requirements, and guidance along the roadmap implementation. All that delivered by one supplier, with no need to spend extra budget and time on growing in-house expertise to reach compliance with regulations.

Leveraging
14 Years
of Experience in Compliance Consulting
Certified
ISO 9001/27001
Lead Implementors and Auditors

Our Clients Choose Us For

Wide Expertise

Our regulatory compliance expertise covers diverse domains and industries.

From quality, cybersecurity, and privacy to healthcare and automotive sectors.

Cost Efficiency

We customize your change strategy, making it both efficient and budget friendly.

By applying our groundworks and maximizing the use of your current tech stack.

Tailored Approach

Compliance strategy is unique for each case and depends on business specifics.

We create individual plans, carefully assessing action steps and changes needed.

Ongoing Support

We complement our compliance framework consulting services with ongoing support.

Our team monitors regulatory changes to timely optimize your compliance efforts.

Learn how our team would solve your business problem

Regulatory Compliance Services

Compliance Assessment

A wholescale assessment will give a holistic view of your compliance level and help accurately mark improvement areas for your future strategy. This approach eliminates the risk of budget outruns and increases the chances that your new framework will take hold and give the expected value.

Our compliance team uses custom criteria for benchmarking your current processes against regulatory requirements to safeguard a comprehensive and deep evaluation of your existing operations. This way, we can precisely identify the gaps and provide you with a detailed action plan that will help you achieve compliance in the shortest terms and with optimized resources.

Regulatory Requirements Implementation

Compliance with regulations may require additional expertise, especially when it comes to industries with intricate legal environments. The optimal solution in this case is to engage a competent external provider who will assist you with changes implementation and make sure they fully integrate into your operations.

At Sigma Software, we grew a center of excellence specializing in a wide range of regulations across diverse fields, including quality, privacy, cybersecurity, healthcare, automotive & more. Bringing together compliance, security, and technical expertise, our team will help you navigate the complexities of new requirements and guide you on how to apply them without disrupting your business operations.

Related Cases

Regulatory Compliance Project in 3 Steps

Assessment

As the first step, we assess your current compliance posture to plan further actions towards achieving your compliance with regulations requirements.

At this stage, we:

  • Perform audit of existing policies and processes
  • Identify and document areas for improvements
  • Plan and estimate the compliance project

Implementation

The next stage, our regulatory consulting experts will help you implement and adjust key processes based on the plan outlined in the earlier stage.

At this stage, we:

  • Evaluate and select the best-fit implementation options
  • Integrate necessary policies and procedures
  • Configure compliant processes across an organization

Support

Our support services include continuous regulations monitoring, their timely update, and recommendations on how to sustain regulatory compliance.

At this stage, we do:

  • Recurring processes, policies, and procedures audits
  • Consulting and advisory on compliance-related questions
  • Continuous tracking and updates on regulatory changes

Related Services

Cybersecurity Consulting Services

Engage our battle-tested team to establish & optimize your security framework.

Big Data Analytics

Use our expertise to get analytics based on the data engineering best practices.

DevOps Consulting Services

Make your infrastructure & operations efficient using our DevOps gurus help.

Software Testing

Strengthen your product with solid quality practices and our testing services.

Modernization and Migration

Get our expert guidance to audit, modernize & move your legacy to modern rails.

DORA Compliance Services

Rely on our compliance team to align your operational setup with 5 DORA pillars.

Standards and Regulations
We Help Comply with

iso-9001-2015
ISO 9001:2015
iso-27001
ISO/IEC 27001:2022
iso-13485-2015
ISO 13485:2015
soc2-type2
SOC II Type 2
gxp-gamp5
GxP: GAMP 5
iec-62304
IEC 62304
aspice
ASPICE
eu-ai-act
EU AI Act
eu-annex11
EU Annex 11
gdpr
GDPR
nis2
NIS 2
dora
DORA
fda-title21
FDA Title 21
nist-csf
NIST CSF
iso-42001
ISO 42001

Let us discuss how our team can contribute to your success

Sigma Software has offices in multiple locations in Europe, Middle East, Northern and Latin America