GxP Compliance & CSV / Software Validation

Companies in the life sciences must be able to meet a wide range of requirements. Apart from customer needs, these include laws, standards and directives, compliance with which can be very closely monitored and whose fulfilment is a condition for market entry in the first place. These include requirements for the implementation and operation of computerised systems (FDA 21 CFR Part 11, EU GMP Annex 11 and Annex 15). At the present time, topics such as data integrity and protection from counterfeit medicinal products now also have a key role to play.

Today, all activities for the implementation and fulfilment of regulatory requirements are referred to in general as “compliance”. In a software context, the related concept is therefore “GxP compliance”. For companies working in the pharmaceuticals and medical technology industries, Computerized System Validation (CSV, software validation) forms an integral part of GxP compliance.

Our firm has been offering consulting services in the life sciences and working in the field of GxP compliance since 1996. Our first clients were SAP customers from the pharmaceuticals industry, who needed to validate their systems due to stringent regulatory requirements. Validation accordingly became one of our key consulting topics, and so we developed a process-oriented and risk-based DHC validation method. We orient ourselves naturally here on the lifecycle model (V-Model) according to the latest version of GAMP, the relevant ISO standards (e.g. ISO 13485) and the regulatory requirements of the FDA (e.g. 21 CFR Part 11) and European regulators (e.g. EU GMP Annex 11).

We offer you a full and comprehensive set of services focused on GxP compliance. These services also include the standardisation and harmonisation of validation and qualification measures, so as to meet the widest possible range of regulatory requirements. These services aim to simplify your IT QM, thereby saving you both time and money.

Our specialised know-how related to validation and GxP compliance is further complemented by our industry experience as well as our expertise in process and project management.

Compliance Consulting

Compliance is more than just the creation, approval and filing of SOPs and all related templates and documents.

DHC analyses and designs your compliance processes in IT and shows you solutions for integrating them organisationally into the department. We provide you with the necessary content and tools, and we process the results in compliance-compliant SOPs.

Validation Services

You are implementing a new system or are facing an important FDA or major customer audit. Your capacities are not sufficient to complete the upcoming tasks for the validation of the systems on time. We have the right and reliable employees for this, who are available to you on a temporary or long-term basis as required.

Validation as a Service (VaaS)

On the basis of a service contract, our experts are available to you on demand and at short notice. You communicate the task, we plan the effort and schedule the service that you release. In this way, you retain full cost control with maximum flexibility. The service includes all common IT compliance tasks.

Managed Validation Services

You take care of the IT, we take care of the regulatory compliance (Managed Validation Services). Your IT department and DHC work hand-in-hand across the company. Regular updates, innovation packs or necessary changes to your system are no longer “slowed down” by computer system validation and thus lose their regulatory scare.

On the basis of a service contract that also guarantees a high level of confidentiality, we take on all compliance tasks that arise during the validation of SAP ERP systems (ECC 6.0 and S/4HANA). To this end, we “plug in” to your change process and ensure that all compliance-relevant tasks are completed on time and in compliance with the rules.

Mohammad Anwar Hossain, Project Manager, SAP project ‘UTTORON’, Deputy General Manager, IT, Incepta Pharmaceuticals Ltd., Dhaka

“DHC made the most effective job in our project. Many of their activities not only assured the goal of a prospective validation of SAP ERP ECC 6.0, but also reduced the project risk. Due to the structured approach with SAP processes and business scenarios and defining the business requirements in URS documents, we were pretty sure, that the new ERP system will cover the daily business of Incepta.”

Use our experience as specialists for GxP Compliance::

More than 25 years of expertise in computerized system validation in pharmaceuticals/life sciences and medical technology
Numerous successfully completed prospective and retrospective validation projects
Scalable DHC Best Practice Validation Method / Validation Content
High audit reliability
Strong team of CSV managers with profound knowledge of regulatory requirements (GAMP, FDA, GxP, ISO 13485, …)
Long-term and trusting cooperation with our customers
Ensuring the transfer of knowledge to you as a customer