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Validator Modules

Validator Modules

Validator is a comprehensive automated validation tool that is pre-configured for project creation, document building, workflow, and change control right out of the box.  For organizations that aren’t seeking a complete solution we also offer Validator in separate software validation modules.

WORKFLOW MODULE

Validator Workflow Module allows you to:

  • Automate workflow and streamline operations by eliminating the costs and time associated with managing a traditional paper-based review and approval process.
  • Easily upload paper and electronic documents into workflow. Validator allows you enter documents whether they are being captured from a scanner, computer file, email or Microsoft Office®.
  • Receive email alerts for approvals and reduce delays in the approval process.
  • Rapid document approval. Validator’s workflow module allows you to send documents to a number of approvers, and choose simultaneous approvals or multi-tier approvals.

This software validation module provides the following key benefits:

  • Document monitoring throughout the entire process.
  • Easy access via internet browser, with no client installation required.
  • Audit tracking throughout the entire process.
  • Flexible interface made compatible with existing technologies using web services.
CHANGE CONTROL MODULE + WORKFLOW MODULE

Validator Change Control Module helps companies implement system and process changes while staying compliant.

Given the number of ongoing processes for document change in formulations, design specs, SOPs, specifications for raw materials, etc., companies without electronic change control have trouble staying compliant. For many companies adherence to regulations set by bodies such as the FDA is a top priority - our change control software validation module can help.

Validator’s change management software addresses the requirements for managing the change control process according to regulatory guidelines. This helps when introducing, planning, and implementing changes to various business processes.
This module further simplifies the change control process by electronically work flowing change documents, including supporting evidence for the change, to the appropriate people for approvals. (See WORKFLOW for more info) All approvals and signatures are given electronically, and done in accordance with CFR PART 11 regulations.
This software validation module provides the following key benefits:

  • Electronic Review and approvals.
  • Searchable change control content.
  • Flexible interface with existing technologies using web services.
  • Unlimited attachments of supporting evidence.
  • Impact analysis and system assisted impact analysis when combined with other Validator features.
  • WORKFLOW MODULE INCLUDED
COMPUTER SYSTEM VALIDATION

Computer system validation is the technical discipline that pharmaceutical and other life sciences companies use to ensure that information technologies perform to their intended purpose. Quality guidelines set by the FDA and other regulatory agencies impose the need for specific controls and procedures for a software system’s lifecycle. Evidence that these controls and procedures have been followed must be thoroughly and accurately documented. The activities involved in applying the appropriate controls and procedures are part of a process called, computer system validation.

Unfortunately, a large majority of companies perform these validation activities using a manual, paper based process, which can be highly time consuming and resource intensive. It also presents many challenges such as, lack of consistency and quality in documentation, inadequate testing and execution, as well as poor records and lack of change control.

Validator is a purpose built validation software system, designed to automate the validation process from start to finish. Validator performs 40%-60% faster than a manual, paper based system, and guarantees a return on investment (ROI) after the first project.

Validator provides the following key benefits:

  • Customizable documents & reports.
  • Requirements and test procedure management.
  • True content and document management.
  • Electronic execution of test scripts.
  • Automatic and instant traceability.
  • Ad-hoc creation of deliverables and documents (flexibility of templates).
  • WORKFLOW MODULE INCLUDED
  • CHANGE CONTROL MODULE INCLUDED
EQUIPMENT QUALIFICATION

Much like computer system validation, equipment qualification serves to verifying that machinery/equipment used in the manufacturing of drug products perform as intended under controlled and pre-defined conditions.

Validator is a fully automated software validation system that ensures your equipment qualification follows regulatory standards and Good Manufacturing Practices (GMP), as required by the FDA and other regulatory agencies.

Validator provides the following key benefits for equipment qualification:

  • Automation of deliverables including FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing).
  • Electronic execution of FAT and SAT.
  • Automatic and instant traceability.
  • WORKFLOW MODULE INCLUDED
  • CHANGE CONTROL MODULE INCLUDED
PROCESS VALIDATION and QUALITY by DESIGN (QbD)

Pharmaceutical Quality by Design (QbD) is a systematic approach to product and process development, based on sound science and quality risk management (ICH Q8R2). QbD facilitates innovation and continuous improvement throughout the product lifecycle. Increased process knowledge and product understanding resulting from QbD can increase the efficiency of manufacturing processes, reduce product recalls, and solidify compliance actions – all of which lead to cost savings for pharmaceutical companies.

The three stages of process validation as defined by FDA regulations are known as

  1. Process Design = Quality by Design
  2. Process Qualification
  3. Continued Process Verification (PAT)

Our Process Validation Module automates this 3-stage process to enhance efficiencies, cost savings, and compliance actions.

This software validation module provides the following key benefits:

  • Electronic definition of product goals via establishment of Quality Target Product Profile (QTPP).
  • Electronic application of risk assessments to identify the critical parameters or attributes.
  • Electronic capture of Critical Quality Attributes (CQAs), identifying the CQAs based on prior knowledge and QTPP.
  • Automated linking between CPP & CQAs, using risk management techniques to prioritize the critical parameters.
  • Documentation of key learnings and plan for future direction.
  • Execution of determined control strategy and test plan.
  • Execution of protocols and related testing.
  • Data analysis based on imported results from your Laboratory Information Management System (LIMS).
  • Interfacing to existing ERP for batch-centric information.
  • Execution of reporting.
  • Trend analysis across or within process validation projects.
  • WORKFLOW MODULE INCLUDED
  • CHANGE CONTROL MODULE INCLUDED
CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) AND WORKFLOW

CAPA is a concept within the good manufacturing practice (GMP), and numerous ISO business standards. It refers to a systematic investigation of the root causes of identified problems or risks, in an attempt to prevent their recurrence throughout the validation process.

Our validation software module will automate your existing CAPA management process and allow you to workflow (see WORKFLOW) your CAPA deliverables to all stakeholders within your organization for review, approval, and execution. Historical CAPA related information is also easily accessible.


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