Managed Validation Services

The fulfillment of regulatory requirements for software validation is increasingly becoming the focus of auditors. In addition to the resulting compliance risks, costs in particular are rising.

For small and medium-sized enterprises, this development is becoming a cost trap. Meeting GxP requirements is not one of the core competencies of the companies concerned, so they understandably try to keep the associated effort and costs of achieving compliance as low as possible.

However, there are few specialists for software validation on the job market, i.e., qualified employees who have interdisciplinary knowledge of both IT and compliance are rare and salaries are correspondingly high. In addition, there is a high level of competition for these employees and large pharmaceutical groups in particular have a clear advantage here.

With DHC’s “Managed Services for Validation”, these problems can be solved easily, at manageable and, in particular, calculable costs in the long term. With Managed Services, we take over validation services for our customers and, depending on the desired level of support, provide them with the necessary compliance concept, methods and resources for achieving and maintaining compliance. In doing so, we draw on more than 20 years of experience in this field. The effort required depends to a large extent on the degree of compliance defined jointly in advance.

Depending on the initial situation, we offer service packages in the area of Managed Validation Services that are specially tailored to your customer needs – these range from targeted, project-related support to a full service package:

You determine which service suits you best:

You have validated with or according to the DHC methodology, but decided to perform the operational validation activities independently.

We proactively inform you about new or changed system functions that support your GxP-critical processes. We name the affected processes and provide tips or guidance for re-validation or change management of the SAP system. You perform the validation activities independently.

Service of DHC:
Analysis of the business processes where changes have been made and communication of these to the customer. Suggest actions on a methodological, technical, not content level.

Frequency:
According to IPs and release cycles of SAP.

If possible, you have performed the validation with or according to the DHC methodology, but you have decided to perform the operational validation activities independently. If necessary, you temporarily take a DHC expert on board.
For authority and customer audits (with IT or SAP focus), DHC is at your side as a validation expert and supports you in the audit process from preparation to successful execution.

Service of DHC:
Conducting friendly audits, support in updating documents incl. critical review, readiness to answer possible expert questions from authorities and customers.

Frequency:
As needed

If possible, you have carried out the validation of the ERP system with or according to the DHC methodology. A separate validation team, which carries out the operational tasks itself, temporarily takes an expert from DHC on board.

DHC monitors changes to the system, whether due to new releases or changes implemented by the customer, performs a risk analysis, names the documents to be revised and checks the result. The customer performs the operational tasks independently on its infrastructure and with its individual systems. All validation work is also performed on behalf of, in the name of, and in the IT landscape of the customer.

Service of DHC:
Analysis of documents regarding correctness, GxP compliance and formal errors; planning, coordination and monitoring of document release.
For this, DHC guarantees compliance conformity.

Frequency:
As needed – usually during Changes.

You have validated the ERP system with or according to the DHC methodology, if possible. You would like to outsource the tasks and activities to maintain the valid state of the system. DHC takes over all tasks of a classical IT-QA.

The necessary tests, transports, etc. to the production system will be performed by the customer and controlled by DHC.

Service of DHC:
Risk analysis, document changes, revision as well as provision of the test plans, review and monitoring of the tests as well as the formal requirements (including signature regulations).

Frequency:
Demand-driven; starting point is changes or releases.

You have decided to implement and prospectively validate SAP S/4 HANA. You would like to outsource the tasks and activities for initial validation and maintaining the valid state of the system after Go Live.

DHC service:
Project Preparation:
Mediation of all tasks for the initial validation of the SAP system during the implementation, training or mediation of the validation method and definition of the requirements for the implementation team from a validation perspective, provision of all required documents (validation plan, SOPs for SAP validation, digital process landscape, templates for URS, FS, DS, customizing documentation, risk analysis, test plan, test cases, validation report, business processes, detailed processes, partially user requirements – all content specifically tailored to the Life Science Industry).

Project support:
Providing the PQM, creating all validation documents as part of the implementation project, performing the risk analyses, creating the test plans and test cases, performing the tests (optional), creating the validation report, supporting the system release, keeping the system in a valid state after go-live, i.e. adapting the URS + FS documents, performing the risk analysis, adapting the SOPs if needed in the Hyper Care phase.

In the System Life Cycle:
After the Hyper Care Phase, DHC performs all IT QA tasks in the context of changes and release upgrades as well as upcoming authority and customer audits, e.g. risk analysis, document changes, provision of test plans, review and monitoring of tests, review and monitoring of formal requirements (including signature regulations).
Tests, transports, etc. are performed by the customer and controlled by DHC.

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You have validated the ERP system with or according to the DHC methodology, if possible. You would like to completely outsource the tasks and activities to maintain the valid state of the system.

DHC service:
DHC takes care of all IT QA tasks, e.g. risk analysis, document changes, provision of test plans, review and monitoring of tests, review and monitoring of formal requirements (including signature rules).
In addition, it takes care of the execution of the tests of the system and provides its infrastructure (ticket system, DMS, workflow, electronic signature, process modeling) on a customer-specific basis.
The transport of changes or modifications remains in the hands of the customer.

FIXED CONTACT PERSON

We defined the service catalog together with you and then provide you with a DHC service team that knows your requirements and processes and helps you within fixed response times.

MORE FLEXIBILITY

The DHC service core team is recruited from experienced CSV specialists at DHC. Depending on technical or capacity requirements, we can react quickly and flexibly.

SIGNIFICANT TIME SAVINGS

Eliminate the need to search for and onboard “suitable” consultants; simply use DHC’s service team, which already knows your requirements and processes. By integrating DHC’s Managed Validation Services into your IT processes (e.g. change management), you increase efficiency.

CONSISTENTLY HIGH QUALITY – PROVEN BY KPIS

We ensure the quality of our managed validation services through our own quality control and prove it through KPIs (service performance indicators) agreed with you.

COST REDUCTION AND COST TRANSPARENCY

Our service-oriented pricing model guarantees you full cost transparency.
The costs for search, onboarding, equipment and above all coordination are eliminated.

Benefit from our methodical, process-oriented and risk-based validation approach to software validation

More than 25 years of expertise in computer 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