Data Integrity Assessment and remediation

The world of life sciences manufacturing is ever growing and evolving, and we’re not just talking about product trends. The increasing impact of record and data integrity problems can stifle the regulated company. Consequences can include costly product recall, warning or untitled letters, import alerts, injunctions, seizures, and ultimately the potential for patient harm.

Although the requirements for data integrity are not new, there has been increased regulatory focus on all aspects of it. A number of regulatory bodies have published specific regulatory guidance on data integrity, and with improved inspector knowledge and awareness, we have seen an increasing number of citations. Life science companies, having been through a painful and expensive Part 11 introduction in the late 90’s and early 2000’s, are looking for answers. That’s where we come in.

We have had the opportunity to audit and assess data integrity programs at many life science organizations. Our unique tooling helps us to efficiently generate the gap analysis between regulatory expectations and your organization's policies, procedures and practice. Remediation and resource planning follow, which can be used as an effective response to external audit observations.

Assessment. CMS is most often contracted to perform DI Assessments under the client’s internal audit program.

Remediation. CMS is often brought in to do DI remediation in response to regulatory authority inspections or customer audit findings. The bulk of our experience has been working within the United States, Canada, Europe, and Asia.

CSA/CSV Program Development

CSA/CSV Program Development Services provide the support needed to help you build and improve the internal programs that govern and control your system life cycle processes. Building and improving a risk-based defensible and durable CSA/CSV program is an investment that pays dividends again and again.

Our Program Development Services provide development and improvement support for the framework containing the processes, activities, and tasks involved in the end to end data life cycle and the validation of computerized systems.

• Establishing CSA/CSV Program SOPs

• Delivering training on CSA/CSV SOPs

Our Supplier Management services and our CSA/CSV Project Services pick up the service from there to ensure your success.

Training

CSA/CSV & GAMP5 Training

• CMS delivers on-site basic and/or advanced CSA/CSV training to GAMP5 to save you time and travel expenses and enable participation of the right system stakeholders.

• ISPE also provides excellent GAMP training.

Program improvement workshops

• CMS delivers program improvement workshops in interactive forums that involve higher level stakeholders. The output includes improved program level SOPs, templates, and forms.

CSA/CSV program training

• CMS delivers on-site program training that is customized to your existing or improved CSA/CSV programs. This training is tailored to personnel who play roles in system projects (Process Owner, System Owner, IT, CSV SME, QA).

• Higher level program related training is also provided for higher level stakeholders who may not actively participate in lifecycle processes, but are key stakeholders in their performance.

CSV Project Documentation Workshops

• CMS offers project level CSA/CSV workshops that involve stakeholder hands on effort working on the project lifecycle documentation such as change control records, validation plans, requirements specifications, traceability, test cases, protocols, and/or reports.

CSA/CSV Subscription

Subscription services are a relatively new concept to the regulated life sciences, but the concept is not new. Cost savings and efficiencies result from building a CSA/CSV program that is integrated.

The subscription experience:

1. The subscription model starts with an onboarding process where the CSA/CSV program is established and training is delivered.

2. System inventory is updated and systems are put through an initial assessment in accordance with the CSA/CSV program and remediation planning is completed.

3. CSA/CSV Project Services are engaged, if needed.

4. Value is continuously delivered via maintaining the validated state of systems through our CMS CSV SME engagement in steady state effort:

   • Maintaining the CSA CSV program, including updates based on regulatory changes / process improvements

   • Maintaining System Inventory of all computerized systems

   • Providing process clarification and guidance to QA and IT on CSA CSV Procedures

   • CSV vendor management (optional)

   • CSV periodic review

   • Supporting change control for minor changes w/limited CSV work (includes CSV impact assessment, lower risk CSA testing).

Supplier Management

Qualifying suppliers with a risk-based approach and gathering the right system life cycle documentation as evidence can result in vastly reduced validation effort and expense and reduces risk. The right documentation can feed into Quality Risk Management processes. CMS shares extensive experience with supplier qualification that’s based on system criticality and complexity. CMS SMEs are knowledge rich resources that provide customers with support in justifying and documenting their supplier qualification approach. We also provide SME auditing expertise to gather the right supplier system life cycle documentation and quality management system (QMS) process evidence needed to facilitate scaling the validation effort and cost.

The ongoing maintenance of supplier qualification through monitoring, and requalification can help ensure there is not significant adverse impact on operations resulting from maintenance activities such as patching, upgrades, hotfixes, etc.

We use the system initial risk assessment based on system overall criticality based on the business process it supports, the GAMP System/Software category, and system novelty and complexity to determine the risk-based approach to each supplier qualification so that Supplier qualification results support the rationale for the extent of reliance on supplier development and testing. 

Internal Audit Support

CMS provides support for internal auditing as a CSV SME and often plays the role of lead auditor when the audit is focused on CSV, QRM and/or Data Integrity.

CMS supports internal audit departments with Subject Matter Expert (SME) knowledge resources.

CMS SMEs are knowledge rich ASQ CQA certified resources that provide customers with the support they need to properly assess their compliance exposure.

CMS personnel are often brought in for Subject Matter Expert (SME) Audit Support to evaluate the effectiveness and efficiency of existing programs. This service is often integrated with our customer's internal audit program, and planned, executed and reported accordance with their internal audit SOPs.

CSA/CSV Project Services

CMS can right-size your project's validation effort with an appropriate, documented, and tailored risk based approach. Our early involvement in the planning process can help you achieve the highest compliance/cost ratio through full implementation of the risk based approach from the start. CMS personnel have worked hard to develop and maintain the rare level of competency required to be able to capture these opportunities for efficiency in developing CSV deliverables.

When the CSV effort is right-sized, validation activities occur throughout the system life cycle with effort and output that are commensurate with risk.

Our CSV Project services are typically requested when system owners are deadline driven to bring a system online. We drive success by working with stakeholders to right-size the project's validation effort with a documented CSA aligned risk based approach.  CMS personnel have the expertise to safely right-size CSV activities and outputs and to appropriately document the justification for the validation approach.

CMS can help you right size your next CSV effort. Contact us so we can show you how our early project involvement can deliver the most savings and least redundancy through full implementation of the CSA aligned risk based approach. Services include:

• Establishing system inventory of all computerized systems

• Completing system initial risk assessment and remediation planning

• Supporting change control for major changes

• Executing CSV projects and managing resources, as applicable

CSV Project Rescue Workshop

CMS CSV Project Rescue is special on-site workshop geared towards getting a derailed project back on track.

There are many reasons a project may stall. One common example occurs when numerous validation deviations are encountered and assigned resources lack the experience to resolve them, and the project sits in a state of deliberation.

CMS has the broad project experience, quality, business, and regulatory capabilities that are needed to move these projects forward. Services include review and analysis of project specific system life cycle and CSV documentation. The workshop output includes an action plan to move the project forward to successful completion.

Policies and procedures

CMS offers Program Services for the development and improvement of the framework containing quality processes, activities, and tasks. These services include quality infrastructure improvement that cover policy, SOPs, forms, and templates that document and control this framework or "Program", for example the “Quality Risk Management”, “Data Integrity”, or the “CSV Program”.

TOOLING - SALESFORCE.COM GXP APPS

We have been involved in developing and validating Salesforce.com apps and components for GxP use for almost a decade. Interim and long term controls needed? Look to CMS pre-configured Salesforce.com solutions for simple and ready answers.