A working reference to the regulations, guidance documents, and standards that govern validated systems and quality operations in pharmaceutical, biotech, and medical device organizations. Entries tagged CSV / Validation Relevant are the ones our candidates and clients reference most often in validation, change control, and quality systems work.
This library links directly to primary sources — eCFR, FDA, ISPE, and ISO — rather than summarizing them, so you're always reading the current version. Standards from ISO, IEC, ASTM, and AAMI are typically sold through their issuing bodies; we link to the official landing page for each rather than a free mirror. We review this list periodically, but always confirm against the source for anything inspection- or submission-critical.
If you're validating, governing, or staffing for an ERP, MES, or other quality-impacting computerized system, these are the documents that come up most.
Electronic records and electronic signatures. The baseline requirement for audit trails, access controls, and e-signature integrity in any validated ERP, QMS, or MES module.
View on eCFR →Final guidance (Sept. 2025; updated Feb. 2026) establishing a risk-based approach to validating production and quality system software, including ERP and MES modules. Supersedes Section 6 of the 2002 General Principles of Software Validation guidance.
View on FDA.gov →The industry-standard risk-based framework for computerized system validation, updated in 2022 to reflect CSA, cloud/SaaS, and agile development. The most commonly referenced non-regulatory guidance in ERP validation projects.
View on ISPE.org →Effective February 2, 2026, Part 820 now incorporates ISO 13485:2016 by reference as the Quality Management System Regulation. ERP and eQMS modules supporting device records, complaint handling, and labeling controls fall squarely within scope.
View on eCFR →Quality management system requirements for medical device organizations, now incorporated directly into 21 CFR Part 820 by reference. Defines much of the recordkeeping and document control logic that ERP and QMS validation has to satisfy.
View on ISO.org →Current Good Manufacturing Practice for drugs. Batch records, change control, and material traceability requirements that any pharmaceutical ERP or MES implementation must be validated against.
View on eCFR →Regulations and guidance governing drug and biologic manufacturing, from cGMP production through controlled substances and harmonized quality standards.
General cGMP requirements applicable to drug manufacturing.
Detailed cGMP for finished pharmaceuticals, including batch production and control records.
Investigational New Drug (IND) application requirements for clinical trial shipment.
Submission and review process for New Drug Applications (NDAs).
General provisions for the manufacture and testing of biological products.
Electronic records and signatures requirements applicable across all GxP computerized systems.
Standards for compounding and drug substance testing, including <795>, <797>, and <800>.
Substance-specific tests, procedures, and acceptance criteria for individual drug ingredients.
Registration requirements for manufacturers, distributors, and dispensers of controlled substances.
Labeling and packaging requirements intended to prevent misuse and diversion.
Prescription requirements for controlled substances, including electronic prescribing.
Harmonized guidance on stability testing, impurity thresholds, and risk-based quality management (Q9, Q10).
ISPE's risk-based framework for computerized system validation, updated 2022 for CSA, cloud, and agile delivery.
Final guidance on risk-based computer software assurance for production and quality system software.
Governs disposal of solid and hazardous waste, including pharmaceutical waste streams.
Regulates air emissions from manufacturing sources to maintain air quality standards.
Hazard Communication Standard for classification and labeling of workplace chemicals.
Occupational exposure standard for hazardous chemicals in laboratory settings.
Controls governing the export and re-export of dual-use items.
Requirements for importing pharmaceuticals and related products into the United States.
Regulations and standards governing device quality systems, design controls, and electrical, software, and sterilization safety — including the QMSR transition now underway.
Quality Management System Regulation, effective Feb. 2, 2026, incorporating ISO 13485:2016 by reference.
Medical Device Reporting obligations for device-related adverse events and malfunctions.
Reporting requirements for device corrections and field removals.
Risk-based software assurance guidance for production and quality management system software.
Quality management system requirements for medical devices, now incorporated into 21 CFR Part 820.
Application of risk management to medical devices throughout the product lifecycle.
Good clinical practice for the design and conduct of clinical investigations of medical devices.
Principles for the biological evaluation of medical devices within a risk management process.
Symbols for use in device labeling, packaging, and accompanying information.
General requirements for basic safety and essential performance of medical electrical equipment.
Software life cycle requirements for medical device software, closely related to validation lifecycle practice.
Application of usability engineering to medical devices.
IEC standards link to the IEC's search portal — titles are not individually URL-addressable on iec.ch.
Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
Human factors engineering principles for medical device design and usability.
Radiation sterilization requirements for healthcare products.
Accelerated aging methods for sterile barrier packaging systems.
Cybersecurity series for network-connectable products, including connected medical devices.
Dose optimization and management standard for CT equipment (MITA Smart Dose).
If a regulatory transition or a system validation effort means you need experienced hands now, we can help you find them.