21 CFR Part 11

Pharmaceutical organizations operate in a highly regulated environment. Documented evidence of quality, safety, efficacy, and practices is a major product alongside the medicinal products they produce. In the information age, electronic records and electronic signatures must be trustworthy, reliable, and equivalent to paper records. Title 21 CFR Part 11 is that part of Title 21 of the Code of Federal Regulations that  establishes US FDA regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, outlines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)). Part 11 requirements do not replace or override other FDA regulations (for example, the Current Good Manufacturing Practice or CGMP) but must seamlessly integrate with these regulations.

ValGenesis solutions are designed to help clients comply with Part 11 and other regulatory requirements with the highest level of security features available today. They ensure the integrity of all generated, modified, and stored data as per the regulatory requirements. ValGenesis solutions make it possible for clients to benefit from the advantages of a fully electronic validation system while also achieving and maintaining 21 CFR Part 11 compliance.

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21 CFR Part 820

Any organization in the medical device industry must achieve and maintain compliance with 21 CFR Part 820 regulations for good manufacturing practice (GMP). From quality control to equipment validation and data tracking, ValGenesis provides all the tools needed to ensure any enterprise can easily and efficiently remain in compliance with 21 CFR Part 820.

21 CFR Part 606

Title 21 of CFR Part 606 outlines the Current Good Manufacturing Practice (CGMP) requirements for blood and blood components, and § 606.160 Records outlines the requirements for record keeping. The Center for Biologics Evaluation and Research (CBER) enforces these regulations via its Compliance Program. Facility inspections are conducted at least every two years, and “problem” facilities are inspected more often. Blood establishments are held to quality standards comparable to those expected of pharmaceutical manufacturers.

The FDA’s guidance document titled Blood Establishment Computer System Validation in the User’s Facility outlines the standards for Blood Establishment Computer Systems (BECS) and their validation. According to this guidance, this BECS validation program must be consistent with recognized principles of software validation, quality assurance, and current good software engineering practices. The guidance also explains the process of validating a BECS system to ensure its fitness for use inits stated purpose,as well as details how facilities are to maintain written plans to ensure that validation is completed fully and consistently maintained in a state of validation throughout its life cycle.

ValGenesis VLMS is designed to allow the efficient management of the entire BECS validation life cycle with tracking validation status in real-time. It streamlines efforts for validation by providing the best possible environment for improved communication between stakeholders. Our solution ensures and enforces consistency throughout the entire validation process, and provides an integrated environment for validation activities such as planning, trace matrix creation, risk assessment, document authoring, electronic execution, periodic review and re-validation scheduling, tracking, and validation document content management.

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ASTM E2500

The ASTM E2500 standard applies to all elements of manufacturing in the pharmaceutical and biopharmaceutical industries, from manufacturing and automation systems to manufacturing facilities, process equipment, process control, utilities, and laboratory/information systems. It applies to new and legacy manufacturing systems and all related auxiliary equipment. This standard is applied throughout the product lifecycle, from concept to retirement. It should be noted that FDA Guidance for Industry Process Validation: Principals and Practice (2011) specifically references ASTM E2500, making it a standard for the industry to follow.

ValGenesis solutions complement existing frameworks and can be configured to offer a risk-based approach to qualification (or a hybrid of traditional and risk-based approaches). Adopting ValGenesis to implement ASTM E2500 standards allows our clients to enforce policies and procedures that employ risk management and verification standards. In addition, our solutions make it possible to enforce policies and procedures that would typically be buried in documentation.

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ASTM E3106 and ASTM F3127

Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

The ASTM E3106 applies the lifecycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals—including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies—as well as to other health, cosmetics, and consumer products. The ASTM E3106 standard provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly, prior to initial use. Validated cleaning processes are important for achieving consistency in both function and biocompatibility. The considerations for these include, but are not limited to, validation approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues.

Both ASTM E3106 and ASTM F3127 prescribe using risk management for cleaning processes and to assess the impact of contaminants (including cleaning agents) on the next product. They describe the identification of contaminants (active ingredients, drug substances, degradants, excipients, other components of the manufacturing process, cleaning agents, etc.), setting science- and risk-based residue limits (How clean is clean?), and a set of clearly defined sampling methods and techniques.

The ValGenesis VLMS is equipped with modules to manage risk assessment, risk control, and risk review as lifecycle processes, as well as impact assessment and manage validation deliverables in a 100% paperless solution to manage the entire cleaning validation lifecycle process. The functions provided by these modules allow for a level of cleaning validation project planning that includes necessary risk evaluation and impact assessment as required by ASTM E3106 and ASTM F3127. This means our clients can effectively plan/manage cleaning validation projects while simultaneously tracking all factors for individual cleaning steps. All of our solution’s tools and features combine to make a robust system that allows for our clients and users to readily meet and comply with all ASTM E3106 and ASTM F3127 standards.

EU Annex 11

Pharmaceutical, biopharmaceutical, and medical device firms using computerized systems to replace a manual operation for CGMP tasks, must assure that there is no resultant decrease in product quality, process control or quality assurance. In addition, there should be no increase in the overall risk of the process. In order to comply with requirements EU regulatory agency – EMA, computerized systems must be validated. For some firms this require transformational changes with the introduction of validation approaches that include use of risk management, risk-based qualification steps, integrated deviation/change management, and ensuring systems are in a continued validated state. These methods give a rise to the concept of a dynamic validation life cycle, wherein users require a real-time access to validated data, risk assessments, risk control strategies, change control systems, and other GxP regulated activities. Such real time access to data can be realized through a system where validated data and their status are maintained electronically. Regulatory compliance agencies such as EMA have encouraged the use of electronic media by introducing regulatory directives (for example, EMA’s EudraLex Chapter 4, Annex 11).

ValGenesis manages the entire validation process, tracking validation status in real time and streamlining the validation effort by providing the needed controlled environment for improved communication between stakeholders. This ensures and enforces consistency throughout the validation process. Our end-to-end automated validation life cycle management solution (VLMS) comes equipped with tools for tracking, planning, traceability matrix creation, risk assessment, document authoring, paperless electronic execution, periodic review, scheduling, and content management. Our VLMS is fully compliant with the requirements detailed in EudraLex Chapter 4, Annex 11: Computerised Systems’ Requirements, and allows our clients’ organizations to meet these requirements for all of their computerized systems.

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PIC/S Guidance

Good Practices for data management and integrity in regulated GMP/GDP Environments

As data integrity violations continue to be found in Form 483’s observations and warning letters, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S) released a 52-page draft guidance outlining how inspectors should conduct facility inspections that adhere to both Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. Data integrity is defined in the document as “the extent to which all data are complete, consistent and accurate, throughout the data life cycle.” Ultimately, PIC/S proclaims that data integrity is fundamental in a pharmaceutical quality system, which must ensure that medicines are of the required quality.

The ValGenesis VLMS is designed to comply with the PIC/S Data Integrity Guidance entitled Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments. Our solution’s advanced security features improve the efficiency of the validation effort and provide significant savings in validation time while simultaneously reducing the potential for data integrity issues. The ValGenesis VLMS removes the human factor from validation by a significant degree, thereby boosting data integrity. In addition, its features satisfy data integrity attributes such as legibility, attributability, contemporaneous recording of activities, consistency of validation procedures, and originality by storing raw data and metadata automatically onto enduring media. Data and documents from the ValGenesis VLMS are available on demand to those who need it, when they need it, since data is copiable onto portable media and available in the secure Cloud.

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ASTM E2500

The ASTM E2500 standard applies to all elements of manufacturing in the pharmaceutical and biopharmaceutical industries, from manufacturing and automation systems to manufacturing facilities, process equipment, process control, utilities, and laboratory/information systems. It applies to new and legacy manufacturing systems and all related auxiliary equipment. This standard is applied throughout the product lifecycle, from concept to retirement. It should be noted that FDA Guidance for Industry Process Validation: Principals and Practice (2011) specifically references ASTM E2500, making it a standard for the industry to follow.

ValGenesis solutions complement existing frameworks and can be configured to offer a risk-based approach to qualification (or a hybrid of traditional and risk-based approaches). Adopting ValGenesis to implement ASTM E2500 standards allows our clients to enforce policies and procedures that employ risk management and verification standards. In addition, our solutions make it possible to enforce policies and procedures that would typically be buried in documentation.

Would you like to know more?

Download our White Paper on how ValGenesis meets ASTM E2500 requirements

ASTM E3106 and ASTM F3127

Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

The ASTM E3106 applies the life cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals—including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies—as well as to other health, cosmetics, and consumer products. The ASTM E3106 standard provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly, prior to initial use. Validated cleaning processes are important for achieving consistency in both function and bio-compatibility. The considerations for these include, but are not limited to, validation approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues.

Both ASTM E3106 and ASTM F3127 prescribe using risk management for cleaning processes and to assess the impact of contaminants (including cleaning agents) on the next product. They describe the identification of contaminants (active ingredients, drug substances, degradants, excipients, other components of the manufacturing process, cleaning agents, etc.), setting science- and risk-based residue limits (How clean is clean?), and a set of clearly defined sampling methods and techniques.

The ValGenesis VLMS is equipped with modules to manage risk assessment, risk control, and risk review as life cycle processes, as well as impact assessment and manage validation deliverables in a 100% paperless solution to manage the entire cleaning validation life cycle process. The functions provided by these modules allow for a level of cleaning validation project planning that includes necessary risk evaluation and impact assessment as required by ASTM E3106 and ASTM F3127. This means our clients can effectively plan/manage cleaning validation projects while simultaneously tracking all factors for individual cleaning steps. All of our solution’s tools and features combine to make a robust system that allows for our clients and users to readily meet and comply with all ASTM E3106 and ASTM F3127 standards.

GAMP 5.0

ISPE GAMP (Current version 5.0) Standards for Computerized Systems

ISPE GAMP (Current version 5.0) industry guidance provides a pragmatic and practical approach to achieving compliant computerized systems fit for intended use in an efficient and effective manner. It is also agile enough to allow for future improvements and innovations. It describes flexible, risk-based methods to compliant GxP-regulated computerized systems, based on scalable specifications and verifications. This remarkable guide addresses an entire life cycle of an automated system and its applicability to a wide range of other information systems, lab equipment, integrated manufacturing systems, and IT infrastructures.

In a nutshell, GAMP5: A Risk-Based Approach to Compliant GxP Computerized Systems provides a framework for a risk-based approach to computer system validation, where a system is evaluated and assigned to a predefined category based on its intended use and complexity. Categorizing the system helps guide practitioners in the writing of a system’s validation documentation (including specifications, test scripts, and everything in between).

With ValGenesis VLMS, GAMP 5 standards can be implemented for any type of computerized system:

  • GAMP System Categorization: The Assessment module available in ValGenesis VLMS helps to define the category of the system based on a decision-tree-driven assessment with a workflow driven approval process.
  • Validation Framework: Required validation deliverables can be enforced as per the validation plan to define validation status, and the system will not be flagged as validated until all deliverables and documents are approved.
  • Risk Assessment: Any type of risk model can be adopted, and risk assessment can be performed at either the system level or the requirement level.
  • V Model Trace: Generation of V model trace can be achieved with minimal effort.
  • Closed Loop Change Management: If there are changes to any artifacts associated with the V model, ValGenesis VLMS dynamically compiles all impacted elements into a single Change Control Validation Summary (CCVS) to review, approve, and execute the summary to mitigate all impacts due to changes to maintain computer system’s validation status.

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