Quality and Compliance
Adhering to Regulatory GMP Requirements in IT
At Hyperbolic, we believe that quality is the foundation of compliance.
A well-designed, robust IT solution ensures that compliance naturally follows, rather than being an afterthought.
By embedding quality into every stage of development, through thoughtful design, rigorous validation, and user-focused interfaces,
we create systems that not only meet stringent regulatory requirements but also enhance usability, scalability, and overall business efficiency.
Quality and Compliance
Adhering to Regulatory GMP Requirements in IT
At Hyperbolic, we believe that quality is the foundation of compliance.
A well-designed, robust IT solution ensures that compliance naturally follows, rather than being an afterthought.
By embedding quality into every stage of development, through thoughtful design, rigorous validation, and user-focused interfaces,
we create systems that not only meet stringent regulatory requirements but also enhance usability, scalability, and overall business efficiency.
Risk-Based Validation Without Overhead
All processes are not equal. One of the cornerstones of GAMP 5 is to take a risk-based approach in order to focus on the critical aspects of a system while avoiding unnecessary validation steps. In practice, this requires working closely with all stakeholders to identify the highest-risk processes and components during the requirements phase.
From our experience, creating traceability matrices and modular testing strategies has proven invaluable in reducing effort while ensuring compliance. By mapping user requirements to functional specifications and linking these directly to validation activities, we eliminate redundant documentation and testing, saving time and reducing costs without sacrificing quality.
Fit-for-Purpose Design
Regulatory compliance alone isn’t enough—systems must also fit seamlessly into GMP workflows. This involves:
Integration with SOPs: Aligning the solution with established standard operating procedures to avoid unnecessary disruption.
Audit-Ready Documentation: Ensuring that all documentation is concise, clear, and readily accessible for inspections.
Balancing Customization and Configuration: Opting for configurable elements where possible to simplify validation and enhance future flexibility.
For example, in developing a batch management system for a biotech client, we tailored the design to reflect existing processes and included user feedback loops. This resulted in a solution that met stringent compliance standards while improving operational efficiency and ease of use.
Fit-for-Purpose Design
Regulatory compliance alone isn’t enough—systems must also fit seamlessly into GMP workflows. This involves:
Integration with SOPs: Aligning the solution with established standard operating procedures to avoid unnecessary disruption.
Audit-Ready Documentation: Ensuring that all documentation is concise, clear, and readily accessible for inspections.
Balancing Customization and Configuration: Opting for configurable elements where possible to simplify validation and enhance future flexibility.
For example, in developing a batch management system for a biotech client, we tailored the design to reflect existing processes and included user feedback loops. This resulted in a solution that met stringent compliance standards while improving operational efficiency and ease of use.
Quality Over Compliance → Moving Beyond the Checklist
Building IT systems for GMP environments should never be about meeting the bare minimum. Compliance may keep you out of trouble, but built-in quality ensures the system genuinely adds value to your operations.
Quality starts by designing systems that not only meet current regulatory standards but are also future-proof and user-centered. From intuitive user interfaces to scalable architectures, high-quality solutions reduce the risk of operational errors, simplify ongoing compliance, and ensure longevity.
In our experience, emphasizing quality over compliance leads to:
Smoother Audits: A well-built system inherently meets or exceeds compliance standards, making inspections straightforward.
Operational Excellence: Quality-focused designs empower end users, reducing the risk of human error and improving productivity.
Sustainability: A robust, well-documented system is easier to maintain and scale, ensuring compliance is maintained effortlessly over time.
At Hyperbolic, we view compliance as the baseline - not the goal. By embedding quality into every stage of design and development, we deliver systems that stand the test of time, enhance operations, and exceed expectations. That’s what GAMP 5 means in practice: creating IT solutions that go far beyond regulatory checklists.
Bridging the Gap Between Compliance and Usability
One common pitfall in GMP-regulated environments is focusing solely on compliance, often at the cost of usability. End users—operators, analysts, and technicians—are critical to maintaining compliance, but when systems are unintuitive or cumbersome, errors increase, productivity suffers, and the risk of deviations rises.
The market’s approach to IT solutions often falls into two extremes. Large IT agencies and providers of systems like MES or ERP focus heavily on features and compliance. While thorough, their solutions are often complex and difficult to use, significantly reducing operational efficiency and increasing the risk of human error.
On the other side are smaller, agile IT agencies known for sleek, user-friendly solutions like apps and modern interfaces. While these systems are intuitive, they often lack the expertise to navigate GMP requirements, leaving clients exposed to compliance risks.
Hyperbolic bridges this gap. We combine regulatory expertise with a focus on usability, ensuring our systems meet the highest compliance standards while being intuitive and efficient for end users. This balanced approach minimizes errors, boosts productivity, and delivers real value for both auditors and operators.
I-I yperbolic
+45 22 26 34 88
Address
Hyperbolic ApS
Vesterbrogade 15, 3
1620 Copenhagen V
Denmark
Follow us
Hyperbolic ApS
VAT no.: DK 45056902
I-I yperbolic
+45 22 26 34 88
Address
Hyperbolic ApS
Vesterbrogade 15, 3
1620 Copenhagen V
Denmark
Follow us
Hyperbolic ApS
VAT no.: DK 45056902
Quality and Compliance
Adhering to Regulatory GMP Requirements in IT
At Hyperbolic, we believe that quality is the foundation of compliance.
A well-designed, robust IT solution ensures that compliance naturally follows, rather than being an afterthought.
By embedding quality into every stage of development, through thoughtful design, rigorous validation, and user-focused interfaces,
we create systems that not only meet stringent regulatory requirements but also enhance usability, scalability, and overall business efficiency.
Risk-Based Validation Without Overhead
All processes are not equal. One of the cornerstones of GAMP 5 is to take a risk-based approach in order to focus on the critical aspects of a system while avoiding unnecessary validation steps. In practice, this requires working closely with all stakeholders to identify the highest-risk processes and components during the requirements phase.
From our experience, creating traceability matrices and modular testing strategies has proven invaluable in reducing effort while ensuring compliance. By mapping user requirements to functional specifications and linking these directly to validation activities, we eliminate redundant documentation and testing, saving time and reducing costs without sacrificing quality.
Fit-for-Purpose Design
Regulatory compliance alone isn’t enough—systems must also fit seamlessly into GMP workflows. This involves:
Integration with SOPs: Aligning the solution with established standard operating procedures to avoid unnecessary disruption.
Audit-Ready Documentation: Ensuring that all documentation is concise, clear, and readily accessible for inspections.
Balancing Customization and Configuration: Opting for configurable elements where possible to simplify validation and enhance future flexibility.
For example, in developing a batch management system for a biotech client, we tailored the design to reflect existing processes and included user feedback loops. This resulted in a solution that met stringent compliance standards while improving operational efficiency and ease of use.
Quality Over Compliance → Moving Beyond the Checklist
Building IT systems for GMP environments should never be about meeting the bare minimum. Compliance may keep you out of trouble, but built-in quality ensures the system genuinely adds value to your operations.
Quality starts by designing systems that not only meet current regulatory standards but are also future-proof and user-centered. From intuitive user interfaces to scalable architectures, high-quality solutions reduce the risk of operational errors, simplify ongoing compliance, and ensure longevity.
In our experience, emphasizing quality over compliance leads to:
Smoother Audits: A well-built system inherently meets or exceeds compliance standards, making inspections straightforward.
Operational Excellence: Quality-focused designs empower end users, reducing the risk of human error and improving productivity.
Sustainability: A robust, well-documented system is easier to maintain and scale, ensuring compliance is maintained effortlessly over time.
At Hyperbolic, we view compliance as the baseline - not the goal. By embedding quality into every stage of design and development, we deliver systems that stand the test of time, enhance operations, and exceed expectations. That’s what GAMP 5 means in practice: creating IT solutions that go far beyond regulatory checklists.
Bridging the Gap Between Compliance and Usability
One common pitfall in GMP-regulated environments is focusing solely on compliance, often at the cost of usability. End users—operators, analysts, and technicians—are critical to maintaining compliance, but when systems are unintuitive or cumbersome, errors increase, productivity suffers, and the risk of deviations rises.
The market’s approach to IT solutions often falls into two extremes. Large IT agencies and providers of systems like MES or ERP focus heavily on features and compliance. While thorough, their solutions are often complex and difficult to use, significantly reducing operational efficiency and increasing the risk of human error.
On the other side are smaller, agile IT agencies known for sleek, user-friendly solutions like apps and modern interfaces. While these systems are intuitive, they often lack the expertise to navigate GMP requirements, leaving clients exposed to compliance risks.
Hyperbolic bridges this gap. We combine regulatory expertise with a focus on usability, ensuring our systems meet the highest compliance standards while being intuitive and efficient for end users. This balanced approach minimizes errors, boosts productivity, and delivers real value for both auditors and operators.
I-I yperbolic
+45 22 26 34 88
Address
Hyperbolic ApS
Vesterbrogade 15, 3
1620 Copenhagen V
Denmark
Follow us
Hyperbolic ApS - VAT no.: DK 45056902