Regulatory Compliance

Compliance with FDA 21 CFR Part 11

For any company operating in FDA regulated industries, compliance to 21 CFR Part 11 is not an option, but is a necessity. ValGenesis is designed with the most advanced security features, all developed to comply fully with 21 CFR Part 11. ValGenesis will ensure that data created, modified and stored within the application is capable of withstanding the scrutiny of FDA and internal audits while improving the overall efficiency of the revalidation program. By implementing ValGenesis, a company can begin to benefit immediately from the advantages associated with electronic systems while enforcing compliance.

Download the white paper to see how ValGenesis meets FDA 21CFRPart11 requirements. Download

Compliance with EU Annex 11

Pharmaceutical companies are realizing that their manufacturing activities can extensively benefit from an electronic work environment. Giant strides in hardware and software technology during the past decade have been the enablers for such an electronic work environment to meet the demanding information needs of the (bio)pharmaceutical industry.

In order to fulfill the regulatory agencies’ desire for continual improvement, validation has undergone a transformational change with the introduction of validation approaches which involve risk assessment, risk based validation, integrated deviation and change management and ensuring systems are in a constantly validated state. This change has given rise to the concept of dynamic lifecycle validation wherein users require faster access to validated data, risk assessments, risk control strategies, change control systems etc. Such real time access to data is realized through a system where validated data and statuses are maintained electronically. The regulatory compliance agencies also encouraged the use of the electronic medium through the introduction of regulatory standards and guidance such as US FDA’s CFR 21 Part 11 and EMA’s Annex 11.

ValGenesis is a computer based Validation Lifecycle Management System (VLMS). It manages the entire validation process, tracking validation status in real time, streamlining the validation effort by providing the needed environment for improved communication between stakeholders. This ensures and enforces consistency throughout the validation process. ValGenesis is fully modularized with elements for tracking, planning, trace-ability matrix creation, risk assessment, document authoring, paperless electronic execution, periodic review, scheduling, and content management. Besides meeting regulatory compliance, requirements for validation, ValGenesis is also compliant with Annex 11.

Download the white paper to see how ValGenesis meets EU Annex 11 requirements. Download

Compliance with FDA’s guidance document titled Blood Establishment Computer System (BECS) Validation in the User’s Facility

FDA’s guidance document ‘Blood Establishment Computer System Validation in the User’s Facility’ provides assistance to blood establishments in developing and maintaining a blood establishment computer system validation program. According to the guidance, this program should be consistent with recognized principles of software validation, quality assurance and current good software engineering practices. Computer systems used in the process for managing the blood products are complex, as is the management of the donors of those products. Unlike a pharmaceutical manufacturing process where companies test by batch and/or lot, blood product testing must be conducted by donor and/or unit to ensure that the donor’s blood is not contaminated. Management of donors by individual results is highly risky and the guidance aims to explain best practices that can be followed to ensure that these risks are minimized, if not eliminated. The guidance explains the process of validating a BECS system to ensure fitness for use of the system for the stated purpose and how facilities should maintain written plans designed to ensure validation is completed fully and with regularity.

ValGenesis is a computer based Validation Lifecycle Management System (VLMS). It manages the entire validation lifecycle of BECS, tracks validation status in real time, streamlines the validation effort by providing the needed environment for improved communication between stakeholders. This ensures and enforces consistency throughout the validation process. ValGenesis is fully modularized and provides an integrated environment for validation activities including planning, traceability matrix creation, risk assessment, document authoring, electronic execution, periodic review and revalidation scheduling, tracking and validation document content management.

Download the white paper to see how ValGenesis meets FDA’s Blood Establishment Computer System (BECS) Validation in the User’s Facility’ Download

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