As part of different regulatory requirements for pharmaceutical industry standards, the eQMS software needs to comply with several quality specifications and regulatory requirements for US FDA Title 21 CFR Part 11 Electronic Records and Electronic Signatures guidelines, US FDA Title 21 CFR Part 820 Document Controls guidelines, EU Annex 11 Computerized Systems guidelines, ISO 13485:2016 Control of Documents and Control of Records guidelines, and other GMP guidelines. As a result, the Computerized System Validation (CSV) is the prime requirement for any Pharmaceutical eQMS Software. To help pharmaceutical industry with this validation process, IntellaQuest incorporates the complete validation service along with its eQMS software package and quality consultancy.

Pharmaceutical eQMS Software Validation Best Practices

Gap Analysis:

The subject matter experts team provides complete quality consultancy during the implementation phase of IntellaQuest eQMS Software following all industry standards. As the same time, they perform a thorough gap analysis for any specific regulatory compliance guideline to propose the best practice for particular use cases. The partial or full compliance to any guidelines can be achieved based on the gap analysis for each use case.

Risk Assessment:

The high-level risk assessment for each user requirement specification (URS), functional requirement specification (FRS), or Technical requirement specification (TRS) will be performed before creating the test script for the validation protocols. Bases on the ISPE GAMP5 risk-based approach, the risk Classification, Severity, Likelihood, and Detectability will be calculated for each requirement specification. The potential failure consequence or impact assessment criteria will be finalized for system requirement before performing the risk assessment and populating the risk matrix.

Policy Writing:

IntellaQuest can help to formulate all the CSV related quality policies, quality manuals, training materials for the required use cases. It could include Validation Master Plan (VMP), Standard Operating Procedure (SOP), Change Control Procedure (CCP), Risk Assessment Procedure (RAP), etc. which are not part of the validation procedure. If the user already contains established procedures, IntellaQuest can perform all validation activities based of those guidelines also.

Protocol Template:

Bases of client’s requirement, IntellaQuest provides the blank protocol template documents which could be utilized to complete the protocol documentation for execution. The IntellaQuest eQMS software validation protocol templates consists of complete V-Model validation lifecycle documents including planning documents, requirements specifications and requirement traceability matrix documents, risk assessment and risk matrix documents, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), etc.

Protocol Creation:

For the existing quality operation use-case for specific regulatory compliance standards, IntellaQuest can perform the complete protocol creation including all test script designing and document formatting. The formats can be client given or designed from scratch.

Protocol Execution:

After protocol creation, IntellaQuest can perform the protocol execution service to client’s facility either online or on-site based of client’s requirement. It includes all test script pre-approval, test-execution, post-approval, and report generation including objective evidence in collaboration with client’s validation team.

Validation Training:

As part of regulatory requirement, IntellaQuest provides validation training to all the signatory personnel who will be signing the validation protocol for pre-approval, test step result review, test script final review, post-approval, and final validation report. Also, for protocol self-creation as well as self-execution, IntellaQuest provides complete training to the entire validation team.

Certification:

IntellaQuest provides in-house certificate of validation and conformity to any regulatory standard as well as training certificates based on client’s requirement. As well as full or partial revalidation after a change following proper change control procedure based on risk-impact analysis of the change and periodic revalidation to keep the system in a validated state for certification will be maintained by IntellaQuest.

Audit Assistance:

IntellaQuest helps the client to maintain the eQMS system in audit-ready condition throughout the lifecycle for any expected internal or external audit anytime. It includes the overall system maintenance, change risk-impact analysis, periodic revalidation, revalidation after a change, validation protocol documentation, and any other documentation which could be necessary. Also training the eQMS software users for possible audit questions and auditor expectations.

Records Control Management System

CHALLENGES ADDRESSED

  • Records scattered across SharePoint, shared drives or individual computers
  • Difficult to ensure only authorized people creating and accessing records
  • Impossible to locate historical records in paper based or file-based storage
  • Uncertainty in ensuring required recurring records (hourly, daily, monthly, quarterly, yearly) are actually generated on time
  • Approval flows manual or non-existent for approval and issuance of records
  • No ability to easily find associated records
  • No notifications to concerned parties on issuance of records
  • No mechanism to execute retention and disposal policies for records
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