Standard Operating Procedure Writing for Regulated Organisations
Pubrica writes standard operating procedures, work instructions and forms for organisations working under GxP and ISO 13485 quality systems. Our quality and regulatory writers map each process as it is actually performed before drafting, so that the procedure matches the work and can be followed in practice. Each SOP names the responsible roles, specifies the records created and their retention, fits within the wider procedure set without overlap, and includes a revision path. Training material can be prepared alongside the procedures.
- Written from the process as performed, so that staff follow the procedure rather than working around it
- Responsibilities assigned to named roles, not departments, so an inspector who asks who performed a step receives a clear answer
- Records specified: what is created, where it is held and how long it is kept, because an unspecified record requirement leads to missing records
- Scoped to avoid overlap across the set, since contradictory procedures are an inspection finding in their own right
- A defined revision path, because a procedure that is difficult to update tends to be ignored
SOPs, work instructions and formsIncluded
Process mapping before draftingIncluded
Set-level scope and overlap reviewIncluded
Training material to accompanyQuoted with the set
Auditing your complianceRequires an independent auditor
Process → mapped → drafted → tested → procedure
- Written from the process as performed
- Roles named, not departments
- Records and retention specified
- Set reviewed for overlap
- Revision path built in
Deliverables
Four Core Elements of Every Standard Operating Procedure
Each procedure covers one process with one owner, and its requirements reflect how the work is actually performed.
Example from a scope statementThis SOP covers document control.This procedure covers creation, review, approval and withdrawal of controlled documents in the quality system. It does not cover records, which are covered by QA-014, or regulatory submissions, covered by RA-003.
Example from a responsibilities sectionThe department is responsible for reviewing the document.The process owner reviews for technical accuracy, QA reviews for compliance and approves, and the document controller issues and withdraws the document. Each of the three roles has a defined accountability.
Example from a records sectionRecord retention is a recurring inspection finding, and it usually traces back to a procedure that mentioned a record without stating where it is held or for how long.
Example from a set reviewProcedures most often drift from practice not because staff disagree with them, but because updating them was harder than ignoring them.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Regulatory and Quality Standards for Standard Operating Procedures
Your quality system sets the house rules, and these standards define what it must satisfy.
Good Clinical Practice (E6(R3), not E6(R2))
Sets out the clinical-trial procedures a sponsor or service provider is expected to hold, and the oversight expectations behind them.
Medical device quality systems (where devices are in scope)
Sets out the procedure set a device manufacturer is expected to operate, including design control, CAPA and document control.
Record retention and data integrity (ALCOA+ principles)
Defines what a record must contain, where it is held and how long it is kept, which is one of the most common categories of inspection finding.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our quality management system governs how each document is drafted, reviewed, version-controlled and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a named individual. For this reason, source traceability takes priority over speed in our regulatory writing, and every statement must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our Standard Operating Procedure Writing Process Works
We map the process before drafting, because a procedure written from an organisation chart does not reflect how the work is done.
Process Mapping
We walk through the process as it is actually performed with the people who carry it out, including any workarounds, which usually show where an existing procedure needs to change.
Scope and Set Design
We agree the boundaries between procedures at set level so that the set has no overlaps or gaps.
Drafting
We specify roles, steps, decision points, records and retention, following your quality system conventions.
Review and Training Material
We test each procedure with the people who will follow it, revise it and issue it with training material where that is in scope.
Our Experts
Your SOP Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
SOP Writing Service Packages
Pricing depends on process complexity, set size and how much mapping is needed before drafting.
Procedures and work instructions
For organisations building or extending a procedure set
Quoted per projectBased on process complexity and number of procedures
Delivery By scope
- ✓Process mapped before drafting
- ✓SOPs, work instructions and forms
- ✓Roles, records and retention specified
- ✓Scope boundaries agreed at set level
- ✓Tested with the people who follow them
- ✓Two review cycles
Process mapping is the most important stage, because a procedure written without it does not reflect how the work is done.
Deliverables Request a quoteProcedure Set Remediation
For procedure sets that have drifted from practice
Quoted per projectBased on set size and the condition of existing procedures
Delivery By scope
- ✓Existing set read for overlap, gaps and contradiction
- ✓Gap between written process and actual practice documented
- ✓Priority list for rewriting
- ✓Rewritten procedures where warranted
- ✓Revision path rebuilt so drift does not recur
Most sets do not need to be rewritten in full. The first deliverable identifies which procedures need attention, for example ten out of sixty.
Deliverables Request a quoteSend three procedures you suspect are not being followed, and we will explain why at no cost. The cause is usually scope overlap or a records requirement that cannot be met as written.
Usually because they were written without observing the work, or because changing them was harder than working around them.
An inspector documents the gap between the written process and the real one. This is rarely a discipline problem and is usually a problem with how the procedure was designed.
Yes, and it is a good time to write them, provided each procedure reflects the process you intend to operate rather than an ideal one.
Writing procedures early carries the risk of specifying steps that have not been tried. We map the intended process in the same way and mark any assumptions so they can be revisited after the first cycle.
No. Writing procedures and auditing compliance with them should not be carried out by the same party, and an auditor would expect that separation.
We write the procedures and the training material. Independent audit should be carried out by an auditor who was not involved in writing the documents.
Usually fewer than most organisations have. Procedure sets tend to grow by addition, with a finding producing a new procedure rather than a change to an existing one, until the set contradicts itself.
A set-level scope review is usually the most valuable part of our work, and it more often removes procedures than adds them.
Related Services
Related Regulatory Writing Services
Procedures govern how regulated work is carried out and what records it produces.
1WORK GOVERNED BY PROCEDURESclinical and regulatory
Clinical trial supportProtocol, SAP, disclosure and TMF. Medical data collectionCollection, validation and governance.2DOCUMENTS REVIEWED AT INSPECTIONregulatory files
Regulatory writingDossiers, submissions and responses. Forensic and quality auditIntegrity and documentation review.3STAFF TRAININGtraining and implementation
Educational content developmentTraining developed to defined objectives. Learning design and pedagogyStructure, assessment and retention.Request a Free Review of Three Existing Procedures
We will explain at no cost why the procedures are not being followed. The cause is usually scope overlap or a records requirement that cannot be met as written.