When it comes to compliance, life sciences companies don’t get second chances. A missed requalification, a forgotten SOP update, or an incomplete audit trail can be the difference between a product on shelves and a product recall.
In highly regulated environments, especially those governed by 21 CFR Part 11 LMS protocols, MHRA, and ISO standards, the stakes are too high for error-prone, generic learning systems. Yet time and again, even well-established firms fall into the same traps: tracking training manually, storing records across disconnected systems, or relying on LMS platforms that weren’t built for GxP learning or pharma training compliance.
In this post, we unpack the five most common training compliance failures in life sciences, and how validated platforms like ISOtrain help eliminate them before they show up in your next inspection report.
The problem: Many organisations rely on spreadsheets, calendars, or manual reminders to track requalification cycles. This decentralised approach means critical retraining deadlines can be missed, especially in high-turnover departments or where SOPs are frequently updated. Staff may continue working on tasks requiring specific training without realising their qualifications have expired.
Why it matters: Regulators such as the MHRA expect proof of ongoing competency. Missed requalifications are one of the most common findings in UK inspections and can result in critical observations or warnings. It also undermines internal quality assurance, exposing firms to batch release delays, internal investigations, or even product holds.
Published MHRA data from 2019–2020 shows that Quality Systems and Documentation were consistently the top two GMP inspection deficiencies, underscoring the critical importance of training governance.
The fix: ISOtrain automatically monitors requalification schedules by role, SOP, or certification type. It sends alerts to both the learner and their supervisor and locks users out of relevant tasks until requalification is complete. Compliance managers get a clear dashboard view of upcoming expiries and overdue training, helping reduce reliance on manual tracking.
The problem: Training records often exist separately from SOP repositories, making it difficult to prove that staff were trained on the latest version of a procedure. In fast-moving environments, it’s easy for someone to be trained on an outdated version if there is no automated connection between the two systems.
Why it matters: During inspections, regulators will ask: Is this training linked to a specific SOP version? Can you prove it was completed after the most recent update? Without this traceability, companies risk major deficiencies, particularly when the SOPs relate to product handling, equipment use, or critical control points.
The fix: ISOtrain integrates directly with document control systems, linking each training module to the exact SOP version. When a procedure changes, ISOtrain automatically archives the old training, assigns retraining for the updated SOP, and ensures the completion is recorded against the correct effective version.
The problem: Paper forms, shared drives, and email-based workflows are prone to human error. Records may be incomplete, inaccurate, or simply lost. Even digital spreadsheets or simple LMS platforms without built-in compliance features can result in incorrect audit trails or non-standardised training records.
Why it matters: In life sciences, the integrity of training records directly impacts product safety and regulatory standing. Incomplete or missing records can derail inspections and result in costly corrective actions. This becomes particularly critical in pharma training compliance, where robust record-keeping is essential to meet MHRA and FDA standards.
The fix: ISOtrain creates time-stamped, system-generated records for every training activity. Digital signatures, secure access controls, and automatic logging eliminate manual gaps and ensure data integrity. Organisations can demonstrate exactly who completed what training, when, and on which SOP version, all within a few clicks. These features also support full alignment with 21 CFR Part 11 LMS expectations.
The problem: HR manages employee records. Quality manages SOPs. Training is tracked in a separate LMS or spreadsheet. The result is a fragmented view of compliance that leaves gaps in accountability and slows down reporting.
Why it matters: Without integration, it is difficult to confirm whether staff are trained for their assigned roles, or whether training reflects their current job functions. When an inspection occurs, the burden of proving end-to-end compliance often falls on the quality team, who must manually reconcile data across systems.
The fix: ISOtrain connects HR, document control, and quality systems into a single view. It enables automated role-based training assignment and real-time status updates. Quality teams can generate reports by person, department, SOP, or risk category within seconds, helping them respond to auditors with confidence and speed.
The problem: Many firms use generic LMS platforms that are not validated for use in regulated settings. These platforms may support basic training features but lack formal validation documentation and audit-readiness tools.
Why it matters: If your LMS cannot provide Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation, regulators may consider your entire training program non-compliant. This puts the firm at risk of inspection findings, product delays, or even warning letters.
The fix: ISOtrain is a fully validated LMS with built-in support for IQ, OQ, and PQ documentation. Our validation toolkit reduces internal effort and ensures readiness for MHRA, ISO, and FDA audits. With ISOtrain, teams can confidently demonstrate system reliability and compliance at every stage of implementation.
Training mistakes in life sciences are rarely about intent. They are about systems that were not built for the demands of regulated environments.
With ISOtrain, you can:
See how ISOtrain can help your organisation build a smarter, safer, and fully compliant training ecosystem. Book a demo now.