IT Consulting Services

There’s more to Compliance than just passing the audit.

You need to establish a viable and lasting program of consistent processes and documented procedures. Start by defining your compliance goals and roadmap. Perform a gap analysis and risk assessment. Implement compliant security controls, conduct regular internal audits, and monitor for continuous improvement. Prepare your documented evidence for 3^rd party and customer assessments, and follow through on remediation.

Along the way, develop solid training materials and conduct regular training.  Publish and maintain internal and external informational content. Have the answers at your fingertips before the question is even asked.

But be wise about it. Take a risk-based approach, focus on the essentials and doing them right – without overkill. Don’t throw money at the already expensive cost of compliance.

Which is still less expensive than the cost of non-compliance.

And a word of advice when the auditors come to visit: Speak only when spoken to. Answer only what was asked. And don’t offer information.

Most IT compliance realms are regulations and standards created to protect data from vulnerabilities.

The Payment Card Industry (PCI) Data Security Standard protects your payment card data and personal information through security controls like regular vulnerability scanning, penetration testing, and web application firewalls. HIPAA regulations require access controls to protect personal health data.

Whether required by compliance or not, data security and vulnerability management are just common sense.

It’s critical to establish and maintain a robust vulnerability management program, monitor for and stay current on new and emerging data security threats, regularly perform vulnerability assessments, identify remediation actions, and follow through to closure.  

The full software development lifecycle is an ongoing process, ensuring every user has the best possible system to get the job done.

Develop a product roadmap with achievable milestones.

Document requirements of all stakeholders, from frontline end users to upper management needing accurate metrics and reporting.

Determine design – both in form and function, collaborating with software developers.

Execute testing against requirements, for quality, usability, and workflow.

Document, train, release, and repeat, always looking for ways to improve processes and the product. 

Project Management requires a ringmaster who can keep the balls in the air and their feet on the ground.

It’s essential to work closely and work well with team members and stakeholders of every role and function, from sales and business operations to product development and technical experts, both internal and at customer. 

It’s critical to manage stakeholder expectations while ensuring business and compliance requirements are met, and contracted services are successfully delivered.

Project meetings need to be productive, and communication really is key. 

Computer Systems Validation (CSV) follows the software development lifecycle to ensure the functionality and security of computerized systems used in any part of the process to manufacture vaccines, medical devices, pharmaceuticals, and other products regulated by the FDA and EU.

It’s common sense, but requires extensive documentation of all phases of the SDLC, and thorough testing of the system and integrated processes.  As they say, if it isn’t documented, it didn’t happen.

It is a lot. But a well-documented risk-based approach helps you focus your time, efforts, and finances where they needs to be.

Technical writing and content management comes in all shapes and sizes.

Documenting a process in an SOP. Providing clear and concise instructions in a user manual. Creating productive training materials. Maintaining revision control.

There are so many ways to convey and store the information: Printable document. Electronic document management system. Shared workspaces. Online sites or informational “wikis”.

Wherever you maintain or deliver your content, it needs to be easily access, read, and understood by your audience.