FDA Compliance

FDA uses enterprise architecture to standardize and save with consolidation ...
By U.S. Office of Management and Budget
White paper
This white paper outlines the FDA's information technology consolidation solution, driven by an enterprise architecture framework.

21 CFR Part 11: Where are we now?
By Cimquest Inc.
White paper
This white paper from Cimquest Inc. discusses two major changes brought about by the FDA's Guidance for Industry for 21 CFR Part 11: the narrower interpretation of 21 CFR Part 11, and that enforcement discretion is exercised with regard to requirements for validation, audit trails, record retention and record copying.

An enterprise issue, not a point solution
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting shows how life sciences companies can facilitate the FDA's 21 CFR Part 11 regulations through a compliance program office.

The law of electronic records retention for life science industries
By Proskauer Rose LLP
White paper
This white paper by Proskauer Rose LLP describes the legal landscape of records retention law applicable to life sciences companies, including what constitutes a record, electronic signatures and intellectual property issues, and other subjects.

Implementing a global 21 CFR Part 11-compliant CAPA system at Bausch & Lomb
By AssurX Inc.
Case study
This case study by AssurX shows how vision care company Bausch & Lomb used AssurX's CATSWeb system to manage corrective and preventive actions (CAPAs) and provide 21 CFR Part 11 compliance.

Top 10 questions about 21 CFR Part 11 compliance
By Siemens Corp.
White paper
This white paper by Siemens Building Technologies. Inc. answers 10 common questions pharmaceutical engineers might have about 21 CFR Part 11 compliance, particularly electronic records and signatures.

Designed for success: Strong focus on validation for the production of ...
By GE Fanuc Automation
Case study
In this case study, GE Fanuc Automation Inc. helps Alcon-Couvreur N.V. improve processes using software with high-performance trend analysis, integrated security compliant to the Food and Drug Administration's 21 CFR Part 11 regulation, low-cost plant historian and secure base reporting.

Automating document change control
By MasterControl Inc.
White paper
This white paper by MasterControl Inc. describes the quality system lifecycle and the capabilities necessary to automate change control processes to increase efficiency and ensure Food and Drug Administration compliance.

Meeting the requirements of the FDA’s 21 CFR Part 11 regulation
By GE Fanuc Automation
White paper
This white paper by Intellution Inc., later bought by GE Fanuc Automation, explains the FDA's expectations of manufacturers to achieve compliance with 21 CFR Part 11 regulations, and the policies, procedures and best practices needed to achieve compliance.

Drug development: A solution for addressing 21 CFR Part 11 compliance
By SAS Institute Inc.
White paper
This white paper by SAS Institute Inc. provides an overview of 21 CFR Part 11 and SAS's drug development strategy, which has been designed to address the issues associated with 21 CFR Part 11.

Issues in complying with the Prescription Drug Marketing Act
By Cimquest Inc.
White paper
This white paper by Cimquest Inc. provides background on the development of the Prescription Drug Marketing Act (PDMA) and specific regulations associated with it, including distribution, storage, disposal, validation, security and enforcement.

Industrial Extended Automation System 800xA
By ABB Inc.
Product collateral
ABB Inc.'s 800xA human-system interface terminals can operate as integrated control system interface, or can serve as the central operation and record keeping system coordinating connected programmable logic controllers.

FDA Guidance for Industry: Gene Therapy Clinical Trials
White paper
This guidance provides sponsors of gene therapy studies, recommendations regarding the design of studies to include the collection of data on delayed adverse events in subjects who have been exposed to investigational gene therapy products.

FDA, HIPAA and clinical research
By Compliance Gurus Inc.
White paper
This white paper by Compliance Gurus Inc. identifies the similarities between HIPAA regulations and the FDA's Code of Federal Regulations and explain why the healthcare, drug and medical device industries must be mindful of both sets of federal regulations when conducting clinical research.

FDA Guidance for Industry : Manufacturing Biological Intermediates and ...
White paper
The former regulations at 21 CFR 600.11(e)(3) (§ 600.11(e)(3)) required that all work with spore-bearing microorganisms (spore-formers) be conducted in an entirely separate building, or in a completely walled-off portion of a multiproduct building. The Food and Drug Administration (FDA), modified the regulatory requirements for the manufacturing of biological products with spore-formers to...

FDA Guidance for Industry : Manufacturing Biological Intermediates and ...
White paper
The former regulations at 21 CFR 600.11(e)(3) (§ 600.11(e)(3)) required that all work with spore-bearing microorganisms (spore-formers) be conducted in an entirely separate building, or in a completely walled-off portion of a multiproduct building. The Food and Drug Administration (FDA), modified the regulatory requirements for the manufacturing of biological products with spore-formers to...

The drug industry at a crossroad: PAT's role
By NeuroMolecular Pharmaceuticals
White paper
In this white paper by NeuroMolecular Pharmaceuticals Inc., process analytical technology (PAT) is discussed, along with the answer to the question: Why is the pharmaceutical industry taking a sudden interest in PAT it has been utilized for many years elsewhere?

Beyond compliance: The future of pharmaceutical manufacturing
By Cimquest Inc.
White paper
This white paper from Cimquest Inc. discusses the FDA's process analytical technology (PAT) framework, and the challenge facing pharmaceutical industry executives to marry the FDA's vision with the industry's fear of increasing regulation and lawsuits.

Integrating good manufacturing practices during the transition from clinical ...
By Ross Systems Inc.
White paper
According to this white paper by Ross Systems Inc., early adoption of good manufacturing practice (GMP) can lead to a faster, lower-cost ramp-up from clinical trials to full commercial manufacturing, whether in house or outsourced.

Avoiding cGMP non-compliance through effective training techniques
By Clarkston Consulting
White paper
This white paper from Clarkston Consulting discusses the relationship between current Good Manufacturing Practice (cGMP) non-compliance and inadequate training, and how pharmaceutical companies can create effective training.

Preparing for changes in FDA guidelines
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting addresses how companies can adapt to changes in US Food and Drug Administration compliance rules.

cGMP policies: Human drugs, animal drugs and human biological drug products
By MetricStream Inc.
White paper
This white paper by MetricStream Inc. explains the risk-based approach that is part of the FDA initiative for re-evaluating current good manufacturing practice (cGMP) policies announced.

GMP Protective Covers
By General Econopak Inc. (GEPCO)
Product collateral
GEPCO's GMP Protective Covers fit machines, equipment and carts in your production area. Made from strong, durable Tyvek, covers are available in GEPCO’s exclusive GMP print, in white or with a yellow poly-coating.

XFP MES Software
By Elan Software Systems Inc.
Product collateral
XFP-MES software by Elan Software Systems is exclusively designed for regulated sectors of the pharmaceutical industry, optimizes the manufacturing costs while ensuring a maximum of security throughout the manufacturing process.

Risk-based method for prioritizing cGMP inspections of pharmaceutical ...
By FDA Center for Drug Evaluation and Research
White paper
This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) explains the pilot risk ranking model, a risk-based method for prioritizing current good manufacturing practices (cGMPs) inspections of pharmaceutical manufacturing sites.

Bioavailability and bioequivalence studies for orally administered drug ...
By FDA Center for Drug Evaluation and Research
White paper
This white paper by the FDA's Center for Drug Evaluation and Research (CDER) contains advice on how to meet the bioavailability and bioequivalence requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration, including INDs, NDAs, ANDAs, and their supplements.