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Records, Archiving, and Retention Course & Certification
Intermediate
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4.5
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97% Recommended
3 hours
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Records, Archiving, and Retention
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About
Records Archiving and Retention training helps organizations establish effective processes for managing records throughout their lifecycle while ensuring compliance with legal, regulatory, and organizational requirements. It provides practical guidance on creating, classifying, storing, retrieving, archiving, retaining, and securely disposing of records to maintain data integrity, confidentiality, and accessibility.
This Records Archiving and Retention Training Course & Certification provides essential knowledge on records lifecycle management, document classification, retention schedules, archiving techniques, document security, information governance, regulatory compliance, audit readiness, and secure disposal practices. Upon successful completion, learners receive a certification demonstrating their understanding of records management principles and industry best practices.
Who Should Enrol?
- Employees responsible for creating or maintaining business records
- Records Management and Document Control Professionals
- Quality Assurance and Quality Control Personnel
- Compliance, Risk Management, and Internal Audit Professionals
- Information Governance and Data Management Teams
- Managers, Supervisors, and Team Leaders
- Administrative and Office Support Staff
- Anyone responsible for records, document control, or regulatory compliance
What you will learn
Understand the principles of records management, archiving, and retention, including the records lifecycle and regulatory requirements.
Learn how to classify, store, retrieve, and protect both physical and electronic records to ensure accuracy, accessibility, and security.
Develop knowledge of retention schedules, archiving methods, secure disposal procedures, and information governance best practices.
Gain an understanding of compliance obligations, document control, audit readiness, and effective recordkeeping to support business continuity and regulatory compliance.
Course Syllabus
- Why good data and record management underpins patient safety
- Data, information, documents and records — the distinctions that matter
- Raw data, source data, the original record and metadata
- ALCOA and ALCOA+ — every letter, applied
- Static and dynamic records; paper, electronic and hybrid records
- True copy, certified copy, controlled and uncontrolled copies
- Data governance and the data lifecycle
- Data governance: record owner, data owner, system owner, process owner, archivist
- Data criticality and data risk — a risk-based approach
- Good data and record management in GMP
- Good data and record management in GCP
- Good data and record management in GLP
- Distribution records and Good Distribution Practice
- Pharmacovigilance records
- Building and maintaining a record inventory
- Describe the complete lifecycle of a record from planning to disposition
- Apply good documentation practice when recording and correcting data
- Correct a paper record properly — and recognise a bad correction
- Explain how an electronic correction works and what the audit trail must show
- Perform and evidence data review, including audit-trail review
- Explain what active storage, archiving, migration and disposition each require
- Explain why a document hierarchy exists and what each level carries
- Place a document at the correct level
- Describe creation, review, approval and effective dating
- Distinguish master document, controlled copy, uncontrolled copy and working copy
- Apply change control and version management
- Control blank forms and templates, including issue and reconciliation
- Explain document numbering, indexing and the master list
- What a Site Master File is, and what it is for
- Who reads it, and what they read it for
- The expected content, section by section
- Ownership, approval and maintenance
- Keeping it current — the triggers for revision
- Common Site Master File failures
- Identify the information expected in any GxP document
- Describe what specifications and instructions must contain
- Explain what a batch processing and batch packaging record must show
- Recognise the other record families a GxP organisation maintains
- Explain what a reviewer and a Qualified Person are actually looking at
- Archive versus backup — the distinction organisations fail on
- Archive controls: the archivist, access, indexing, environment, security
- Determining a retention requirement: category, jurisdiction, trigger, source
- The seven fields every retention determination must record
- Legal holds — suspending destruction, and releasing a hold
- Migration, format obsolescence and decommissioning a legacy system
- Retrieval commitments, and testing them before an inspector does
- Secure destruction and the certificate of destruction
- Inspection readiness and the common failures
- Recap of the seven modules
- The ten habits of good record management
- The terminology that matters most
- Determining retention — the method, once more
- Inspection readiness and the failures to avoid
- 📘 Bonus: Records, Archiving, and Retention eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with developments in good data and record management practices, GxP documentation and archiving expectations — including WHO and MHRA data-integrity guidance, EU GMP Chapter 4 and Annex 11, PIC/S guidance, ICH E6, the OECD GLP principles and 21 CFR Part 11 — as our training courses are constantly monitored, reviewed and updated. Retention requirements vary by jurisdiction, record category and trigger, and must always be verified against the current effective source.
Learn from Industry Experts
The course content reflects quality assurance, data integrity, archiving and regulatory compliance practice in GxP-regulated organisations, and is built around a fictional case study that follows a single life-sciences company through twelve realistic record-management failures and their remedies.
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