Can you work in our existing SOP template?

Yes. We use your approved template, document structure, terminology, and numbering conventions. If these are missing or inconsistent, template development or cleanup can be included in the scope.

What if we do not have an existing procedure?

We start with the process owner, available equipment information, approved process requirements, and a walkthrough where agreed. Your team resolves missing technical decisions before the document is finalized.

Will the SOP reflect how our team actually works?

We review the workflow with your subject matter experts. Where practice differs from an approved requirement, we raise the discrepancy for resolution; we do not automatically turn the observed practice into an approved instruction.

Do you update the forms linked to the SOP?

Yes, when included. We check that required entries, review points, terminology, and references agree between the procedure and its forms. The quote identifies each document to be revised.

Can you write equipment settings and acceptance limits?

We document settings and limits from approved technical sources confirmed by your team. Where a value lacks a justified source, we flag it for technical resolution rather than inventing a requirement.

Can you help close a documentation finding or CAPA?

We can assess the gap, revise affected documents, and provide a revision summary. Your quality team determines whether training, implementation checks, or other actions are needed and approves CAPA closure.

Can you complete missing historical records?

We can help assess gaps and document the issue through your approved process. We do not backdate entries or create evidence of work that cannot be verified. Historical corrections must preserve traceability.

Who approves the documents and trains the users?

Your authorized process owners and quality personnel approve the documents. Training, issuance, and effective dates follow your site process. Training material preparation or implementation support can be specified separately.

How many revisions are included and when will it be ready?

The quotation defines review rounds and delivery milestones based on document complexity and source availability. We agree on reviewer turnaround and distinguish comment resolution from changes that expand the original scope.

GMP DOCUMENTATION / INSTRUCTIONS THAT MATCH THE WORK

GMP Documentation & SOP Services

Give your team clear instructions and records that match the work they perform.

SOLVE provides GMP documentation services for manufacturing, laboratories, engineering, and quality teams. We develop and revise procedures, forms, and supporting records around your actual processes, equipment, and quality system.

One source Truth

SOPs · Protocols · Records

Your process & terminology

Instructions based on confirmed source information

Connected documents

Procedures aligned with forms and related records

Controlled handoff

Editable files, revision status and open decisions

01/ Study scope

02 / When to map

03 / Our process

04/ Deliverables

05/ Pricing & Quote

06/ FAQs

01 DOCUMENT SCOPE

What can we map?

Your study is planned around the space, equipment, or vehicle you use and the products you need to protect.

01/ DOCUMENT TYPE

SOPs and work instructions

SOP development services for operation, cleaning, maintenance, sampling, review, and other defined activities.

03/ DOCUMENT TYPE

Forms and logbooks

Design entries, checks, signatures, and exception fields around the activity so users know what to record and when

05/ DOCUMENT TYPE

Quality and validation records

QMS documentation services and validation documentation services for agreed procedures, templates, protocols, reports, and supporting records.

02/ DOCUMENT TYPE

Existing procedures

SOP review and revision services to resolve unclear steps, outdated references, missing responsibilities, or differences from actual practice.

04/ DOCUMENT TYPE

Batch records

Batch record development services based on your approved process, with step sequence, material and equipment references, entries, and review points

A DEFINED STARTING POINT

Documentation gap assessment

Not sure which documents need attention? Start with a GMP documentation gap assessment of a defined process or document set.

Written around your process and your users

Our pharmaceutical SOP writing services begin with the people doing the work and the information they rely on. We confirm the sequence, equipment terminology, decisions, required checks, and records before turning them into instructions.

The result should tell a trained user who performs the task, what to do, what to record, and when to stop or escalate. Your templates, terminology, and approval workflow guide the document structure.

02 REMOVE AMBIGUITY FROM THE WORK

Why documentation needs to match actual work

Missing steps, inconsistent forms, and outdated equipment references leave users guessing. Clear documentation gives your team a consistent basis for performing, recording, and reviewing the work.

Make responsibilities, task sequence, and decision points explicit

Connect procedure steps with the forms and records users complete

Resolve inconsistencies across related documents before approval

When do you need documentation support?

Introducing a process or equipment

Prepare operating instructions, forms, and supporting records as part of readiness for a new activity, installation, or transfer.

Changing how work is performed

Update affected procedures and records when equipment, workflows, responsibilities, or approved process requirements change.

Addressing findings or recurring errors

Use GMP documentation remediation to address identified gaps, unclear instructions, or inconsistent records. Connect revisions to the applicable finding, change, or CAPA.

Preparing for document review

Our inspection readiness documentation support helps organize the agreed document set, identify unresolved gaps, and explain revision status and supporting evidence.

Before drafting begins

Bring the sources and reviewers needed to turn your process into clear, reviewable instructions.

Document list, intended users and new-draft or revision needs

Approved templates, terminology and numbering conventions

Existing procedures, forms and approved technical sources

Process owners, subject matter experts and quality reviewers

Reason for the work, target dates and agreed review rounds

03 FROM SOURCE INFORMATION TO HANDOFF

How SOLVE performs the work?

01

Define the documents and intended use

Agree on documents, users, source records, templates, and deliverables. Identify process owners, reviewers, and the review schedule.

02

Understand the actual workflow

Review existing instructions, equipment information, approved process requirements, and related records. Discuss the steps with your subject matter experts and observe the work where included.

03

Draft the instructions and records

Write clear steps, responsibilities, checks, recording requirements, and escalation points. Align forms, terminology, and references with the procedure.

04

Review with your team

Resolve technical comments with process owners and quality reviewers. Check document consistency and, where agreed, walk through the instructions against the equipment or activity.

05

Prepare the controlled handoff

Deliver the agreed clean and marked-up files, revision summary, and outstanding decisions. Your team completes approval, training, issuance, and effective-date controls within your quality system.

SOLVE

Draft & align

Prepare agreed documents, connect procedures with supporting forms, and identify unclear inputs or unresolved decisions.

PROCESS OWNERS

Confirm technical content

Verify the sequence, equipment terminology, approved settings and requirements. Resolve technical gaps and review draft instructions.

AUTHORIZED SITE PERSONNEL

Approve & issue

Complete document approval, process acceptance, training and controlled issuance through your quality system.

Approved requirements guide the instructions. Differences between observed practice and approved requirements are raised for resolution. Missing technical values or unverifiable historical work are not invented.

04 A REVIEWABLE DOCUMENT PACKAGE

What you recieve?

Receive documents with defined responsibilities, usable instructions, and clear recording requirements, prepared for your internal review and approval. Engage us for a single SOP, a document set, or a defined remediation project.

Your quotation identifies the documents and review rounds included:

An agreed document register listing titles, purpose, owners, and scope

Editable drafts in your approved format, with supporting forms or templates where included.

Marked-up revisions and a change summary for updates to existing documents

A review comment and decision record showing resolved comments and outstanding items

A final handoff package prepared for your internal approval and controlled issuance

Missing technical inputs and unresolved decisions are identified for your team. Document approval, process acceptance, training completion, and issuance remain with your authorized site personnel.

FROM DOCUMENT LIST TO APPROVAL

How your handoff can be organized

Connected instructions and records

Align procedure steps, required entries, checks and references across the agreed document set.

Visible review status

Keep resolved comments, missing inputs and outstanding decisions clear at handoff.

Your quotation defines the files, document formats and review rounds included. Final approval and controlled issuance follow your site’s quality system.

YOUR APPLICATION

Documentation for your operation

Manufacturing and equipment procedures

Develop instructions for setup, operation, cleaning, checks, shutdown, and recording. Equipment names, control labels, and operating steps are confirmed against the available source information and agreed walkthrough.

Laboratory and quality workflows

Our GMP technical writing services support defined sampling, record review, deviation, CAPA, change control, and other quality workflows. Responsibilities and handoffs are written so users understand what happens next.

Document control and connected records

GMP document control consulting can review document identification, revision history, approval routes, effective dates, related forms, and obsolete-copy handling. Recommendations follow your existing system and agreed scope.

GMP documentation support in California

SOLVE provides GMP documentation services in California, including pharmaceutical SOP writing services in the San Francisco Bay Area. For GMP technical writing in California, share the process, document list, and review deadline so we can confirm onsite and remote support.

05 SCOPE-BASED PRICING

What does documentation support cost?

Cost depends on the number and complexity of documents, source quality, process walkthroughs, related forms, and review rounds. A new procedure requiring process discovery involves different work from a defined revision to an existing SOP.

Start with your document list

Send your document list, new-draft or revision needs, existing templates, source information, reason for the work, and target dates. Include the process owner and expected reviewers so we can plan the review cycle.

CAT Frequently asked questions

Ready to improve your documentation?

Tell us which documents you need, what is changing, and when your team needs them. We will define the drafting, review, and handoff deliverables for your project.