Solutions

Investigations, especially the ones which conclude with Human Errors as root cause are one of the most prominent concerns in the current regulatory context. Inadequate Investigations, Insufficient Root Cause Analysis and Ineffective CAPA Systems – are amongst the most frequent observations cited by Regulators and often the reasons for Warning Letters.

Heuristics’ approach to make sustainable improvements in investigation management systems will ensure effective remedial, corrective and preventive actions, and create a system in which underlying or recurrent trends can be identified and managed in an effective way.

Even in organizations with successful quality programs, minimizing Human Error is an ongoing challenge. Experienced people working on established processes, often make costly errors inspite of the most diligent efforts to avoid them. Despite the industry’s awareness of Human Errors, companies still frequently fail to substantively and correctly address these errors.

At Heuristics, we help you to answer these questions to understand how your organization can get to the bottom of events and determine what is behind the errors being committed. We thereby aid in establishing a robust and sustainable Human Error Management System with effective CAPAs to reduce Human Errors.

Pharmaceutical manufacturers need to be inspection ready, aligning their organization activities with the expectations of regulatory authorities. However, achieving success in regulatory inspections requires a strategic preparation in advance.

Heuristics can help you avoid those risks by optimizing your preparation for regulatory inspections with our highly experienced pool of experts. and help Clients develop their processes and teams for successful inspections. We can also help by supporting your staff through the inspection, and in preparing and submitting the response to any observations received.

The impact of COVID-19 on Global Pharmaceutical Business is continuing to evolve. There is an expected potential delay in regulatory communication and interaction that will continue for at least next few months (if not years) impacting the business continuity in this much needed sector. While the world regulators have suspended inspection activities, the extensive international travel restrictions and border closures will gravely restrict pre-approval and many other routine facility inspections.

Regulatory bodies are likely to employ Virtual or Remote Inspections where possible as an alternative means to keep the process moving and fulfil the public health demands around the World even after the impact of this Pandemic fades – as complexities seem to continue for the foreseeable future.

Considering this scenario, Heuristics – with our seasoned World experts -have started to help our Clients  prepare their teams for Virtual Audits using the current technology and assist in business continuity planning considerations related to the pandemic and beyond.

Compliance plays a vital role in the Pharmaceutical Industry. Therefore, continual mentoring and educating employees in your organization will have a huge impact. Not just on the employee behaviour, but also on the outcome of operations in terms of quality.

It is imperative that Pharmaceutical employees understand the current challenges and regulatory trends. Particularly as the regulatory requirements in terms of compliance becomes more stringent with each passing day. Developing an effective coaching strategy is the solution to this and there are many ways to do this.

Heuristics partners with organizations to improve Quality Management Systems and Employee Efficiency through its strategically designed Coaching and Mentoring Programs.

Lean methodology is designed to remove “waste” or inefficiency from a process. In the laboratory, waste can negatively impact people and product quality. Waste in the laboratory can take many forms and result in unbalanced workflows, inefficient processes and unproductive teams.

Although Lean principles are typically associated with manufacturing processes, but they can also deliver great improvements in the operation and productivity of the analytical laboratory. Heuristics uses Lean principles for your Laboratory environment to help minimize waste, improve workflow efficiency, and increase productivity in Client Organizations.

Heuristics’ regulatory affairs consultants assist companies to plan and manage their regulatory requirements. Our Regulatory Compliance Management team are Seasoned Industry experts with decades of rich compliance experience and can guide you through sensitive remediation.

Additionally, our knowledgeable Agency Readiness Services team helps you submit high-quality dossiers on time and ensures cGMP-compliant facilities are used to gain regulatory success.

Heuristics has a team of experienced GMP Compliance Auditors with rich experience (More than 25 Years) from leading manufacturing units. Our consultants conduct GMP Compliance Audits, completely overseeing requirements of regulatory agencies. Heuristics Auditors guides the site to nullify deficiency of Audits with gap assessments. We help manufacturers build a road map on how to shape and enhance facilities and QMS to ensure compliance.

We also perform assessment of GMP compliance to national and International Regulatory Standards Reviews, development and implementation of plans for new facilities and proposed facility upgrades to ensure cGMP requirements are met.