IMS Biosciences: GMP, ISO 9001, ISO 22301 & ALCOA+
IMS Biosciences: GMP, ISO 9001, ISO 22301 & ALCOA+
One documented system in which GMP practice, ISO governance and ALCOA+ data integrity all say the same thing.
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Written and reviewed by practising specialists. Who writes this
Built and reviewed with our methodology. Read it
By document type
| Category | Files |
|---|---|
| Manuals | 2 |
| Policies | 1 |
| Procedures & SOPs | 10 |
| Forms & Records | 8 |
| Checklists & Audit Tools | 4 |
| Training & Awareness | 2 |
| Guides & Work Instructions | 3 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-IMS-MAN-01 | Integrated Management System Manual | Word |
| AGS-IMS-PRO-02 | GMP Manufacturing Control | Word |
| AGS-IMS-PRO-03 | Data Integrity ALCOA | Word |
| AGS-IMS-PRO-05 | Business Continuity Management | Word |
| AGS-IMS-FR-05 | Data Integrity Audit Trail Review Record | Word |
| AGS-IMS-FR-06 | Risk Opportunity Register | Word |
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Overview
This Integrated Management System is built for biosciences and biotechnology organisations that have to reconcile Good Manufacturing Practice with ISO discipline. It draws GMP process control, ISO 9001 quality management, ISO 22301 business continuity, ISO 31000 risk management and ALCOA+ data-integrity principles into a single framework, held together by an Integrated Management System Manual, an IMS policy and a documentation structure and process interaction scheme. Teams maintaining separate, disconnected systems work instead from harmonised procedures and cross-referenced records, removing the duplication and contradiction an inspector notices first.
The working layer is the procedure set, running from GMP manufacturing control and data integrity to change control, deviation handling with CAPA, batch record review and product release, business continuity, internal audit and management review. Records enforce attributable, legible, contemporaneous, original and accurate capture, from deviation and CAPA reports to audit trail review records and a master list with retention periods. Guidance anchors the system in WHO TRS 986 and 21 CFR Part 211 and maps how the ISO standards integrate, while self-inspection and ALCOA+ checklists turn clauses into routines a supervisor can run.
What this system covers
- GMP manufacturing control — process control, batch record review and the release decision for finished product
- Data integrity to ALCOA+ — attributable, legible, contemporaneous, original and accurate records, with audit trail review
- Deviation, nonconformity and CAPA — investigation, correction and documented closure
- Change control — assessment, approval and traceability of change across processes and documents
- Risk and continuity — ISO 31000 risk and opportunity registers alongside ISO 22301 continuity arrangements
- Self-inspection and internal audit — GMP self-inspection, integrated audit and a pre-inspection gap review
- Competence — IMS awareness and role-based data integrity training with competence records
Who it's for
Quality and compliance leads in bioscience, biotechnology and contract manufacturing: the start-up preparing for a first GMP inspection, or the established firm consolidating fragmented systems ahead of third-party ISO certification. With a regulator's visit or a certification audit on the calendar, you get the governance backbone, data-integrity safeguards and continuity planning already drafted and cross-referenced, ready to tailor to your products, sites and structure.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
Any of your staff, at any of your own sites. No per-seat fees.
Sector specialists author each toolkit. A principal reviewer with more than twenty years reviews it.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
If a document is wrong, missing or not as described, tell us within 14 days. We fix it or refund you.
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes, for 12 months. Fixes and revisions to this toolkit are free for 12 months from your order. Email us with your order number to get them.
What is your refund policy?
If a document is wrong, missing or not as described, tell us within 14 days of your order. We fix it or refund you. If you have not downloaded yet, we can cancel the order and refund you in full. We don't refund a change of mind after download. See the Refund policy.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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