Pharmaceutical Software Validation Services

We provide a full range of validation services to bring pharmaceutical software systems and practices into full compliance. Our efforts are customized to meet the requirements of each site and have been implemented by almost 100 companies in locations worldwide (North America, Europe, Australia, and Japan).

For each validation effort, we provide regulatory and functional experts to provide clients with a complete solution. Our consultants can provide management, documentation, tests, audits and training to help a company achieve and maintain regulatory compliance.

We provide cost effective validation packages for Oracle® Clinical, Oracle RDC, Oracle TMS, and Oracle AERS.  These packages let you leverage our templates to validate your OLS 4.5 upgrade quickly and at low cost. Please contact us for more information.

Let Us Accelerate Your Validation Process
Validating Oracle Life Sciences (OLS) Applications
Validating Adverse Event Systems
Qualifying Dictionary Implementations and Upgrades
Regulatory and 21 CFR Part 11 Audits
Training, Workshops and Documentation

Validation Services Data Sheet

Oracle Clinical Services Data Sheet

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Let Us Accelerate Your Validation Process

We have developed template validation documentation, as well as generic company-wide SOPs and policies to apply across all validation efforts. When assisting clients in their validation efforts, we start with this library of template documents. These are then customized to each company's specific process. The result is a well ordered and significantly accelerated validation process.

The following are some of the templates that we developed:

Requirements specifications (functional, Part 11, operational, usability)
Validation plans
21 CFR Part 11 gap analysis sheets
IQ/OQ/PQ protocols
Traceability matrices
Validation reports

Validating OLS Apps (Oracle Life Sciences)

Download our OLS Validation Overview

We thoroughly validate OLS installations. More than 50 companies alone have employed our expert OLS validation services.

Our services cover:

Oracle Clinical
Oracle TMS
Oracle RDC, including site qualification and training
Oracle AERS

We offer the full suite of validation documents:

Validation Plan
Requirements
Traceability
IQ/OQ/PQ Protocols

We offer validation tests for all OLS products:

Functional
User Acceptance
21 CFR Part 11
Stress

Tests are executed using CAVS (Computer Aided Validation System), our proprietary integrated testing environment. CAVS provides online testing and a full suite of reports.

Our validation deliverables are ready right ‘out of the box’. Alternatively, they can be customized. We also provide maintenance plans that take care of your future upgrades.

Our management of the validation process has worked successfully at large and small pharmaceutical, biotech, and CRO companies. We combine expertise in regulatory issues with a detailed understanding of the system’s functionality.

We have a full suite of validation deliverables including Requirements, Traceability and Tests for the NLS Version (Japanese) of Oracle Clinical.

Validating Adverse Event Systems (Drug Safety Software)

Our validation services for pharmaceutical adverse events systems cover four major systems:

ArisGlobal ARISg™

Relsys Argus Safety™
Phase Forward Clintrace™
Oracle® AERS

Recent drug safety validation projects that we've done include:

ARISg 5.x

Argus Safety 3.x

Oracle AERS 4.5.x

Our services for these adverse event systems include a full suite of documents:

Validation Plan

Project Plan
Requirements Specification
Traceability Matrix

OQ/PQ Test Plan

OQ/PQ Test Scripts (functional, user acceptance, stress/performance, & Part 11)
Summary Reports

Our deliverables are based on the standard functionality of systems. They are customized to each clients' specific needs. Our validation packages also include E2B requirements and testing.

Qualifying Dictionary Implementations and Upgrades

We have a proven methodology for qualifying dictionary loading and dictionary upgrades. Our methodology includes both the technological and procedural aspect of this difficult process. We have performed several implementations and qualifications including WHODrug and MedDRA.

Regulatory and 21 CFR Part 11 Audits

On March 20, 1997, the FDA published "21 CFR Part 11 – Electronic Records; Electronic Signatures; Final Rule". This rule establishes criteria for FDA acceptance of electronic records, electronic signatures and handwritten signatures executed to electronic records. The regulation applies to all records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirement established by agency regulations. This rule has generated concern about the use of computerized systems in research with regulated products.

Gap Analysis

We perform reviews of systems for Part 11 relevance and compliance that include

Validation
Change control
System maintenance

We deal with both electronic, paper and hybrid systems and handled all aspects of identifications including electronics signatures as well as manual signatures linked to electronic records.

Audits

We conduct audits with a focus on Part 11 compliance both internally for our clients as well as of vendors on behalf of our clients.

Remediation

When a system does not fulfill the requirements of Part 11, but a technological solution (audit trails, reporting, security solutions, etc) is feasible, we can implement a remediation solution. When a procedural solution is feasible, we write an appropriate procedure.

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Training, Workshops and Documentation

We offer general validation and 21 CFR Part 11 training courses. These onsite workshops provide personnel with a detailed understanding of the issues that relate to working in a validated environment. Training is conducted by industry validation specialists. Instructors customize the classes to address company specific issues.