The compliance platform for 503A & 503B pharmacies
SciCord is the only informatics platform built to bring compounding pharmacies from spreadsheets and paper to full Part 11 compliance – built on the workflows your team already knows, not starting from scratch.
No commitment required
IQ/OQ/PQ included
Operational in weeks
| Compliance Status | |
| Electronic Batch Records | ✓ Part 11 |
| Environmental Monitoring | ✓ USP <797> |
| Instrument Integration | ✓ ALCOA+ |
| OOS & Deviations | ✓ CGMP |
| Stability Program | ⚡ ICH Q1A |
| Implement in Weeks | 90% Reduced Cost of Ownership |
| 0 FDA system findings | 30% Reduced Review Time |
FDA system-related findings
across all audited customers
Annual savings at
Formulated Solutions
Saved monthly
at Singota
The problem
They’re about how you documented it: Batch records reconstructed after the fact, EM data that was never trended, Instrument results with no calibration trail, or OOS investigations closed without genuine root cause analysis.
The underlying cause is almost always the same: quality data living in too many places, in formats not designed for compliance, managed by people trying hard but fighting the system instead of being supported by it.
You’re already using a system – a folder of spreadsheets, a stack of paper batch records, and a shared drive nobody can fully navigate.
SciCord’s answer is to use your existing spreadsheets as the starting point for your new system. No abandoned workflows, no rebuilding from zero. Your analysts migrate into a validated, compliant system using the interface they already know.
Batch record reconstruction
Records completed after the fact. No contemporaneous data. Timestamps inconsistent with production records. One of the most cited observations at 503B facilities.
EM data collected but never trended
Monitoring logs exist but data was never analyzed. USP <797> 2023 requires statistical trend analysis for all ISO-classified areas. Paper logs can’t do this.
OOS investigations inadequate
Out-of-specification results closed without genuine root cause analysis. Investigation steps undocumented or out of order. CAPA not linked to the deviation.
to go live, not months
included in implementation
FDA findings at audited sites
A single validated platform covering the full compliance surface area for 503A and 503B pharmacies. No-code. Operational in weeks.
“Can you pull every batch record from the last 90 days right now?”
Your existing batch record spreadsheets are the starting point – not something you abandon. SciCord converts them into validated, Part 11-compliant records with full audit trail, e-signatures, and equipment calibration verification.
Part 11 compliant · Full audit trail · IQ/OQ/PQ included
“Our EM data is in binders. We’ve never run a trend analysis.”
Automated EM scheduling, real-time deviation flagging, microbial tracking, and statistical trend analysis for all ISO-classified areas. USP <797> 2023 compliant. Linked directly to batch records.
77% reduction in daily EM management time
“If the FDA asked us to prove that expiry date, could we?”
Automated stability protocols with scheduled sample pulls, email alerts, and ICH Q1A-aligned trend reporting. Instrument data captured directly, without transcription. Every expiry date you assign is backed by auditable stability data.
ICH Q1A aligned · No manual transcription
“Manual transcription of HPLC results is where our data integrity breaks down.”
Direct connection to HPLC, balances, pH meters, and particle counters via RS232, IP, or file-based integration. Results flow into batch records with instrument ID and calibration status stamped automatically. No transcription, no gaps.
ALCOA+ by design · Zero transcription errors
“We had an OOS result last month. The investigation is still open.”
OOS results automatically trigger the investigation workflow. The two-phase OOS process is enforced by the system — steps completed in order, linked to CAPA, closed with a full documented record. Batches cannot be released with open investigations.
Enforced workflow · CAPA linked · No manual routing
“We’re 503A today but planning a 503B registration. We need infrastructure that scales.”
SciCord supports 503A pharmacies on a CGMP transition path. The same platform that handles your USP <795>/<797> documentation today scales to cover full 21 CFR Parts 210/211 compliance — no system migration, no re-validation.
One platform · Both regulatory regimes · IQ/OQ/PQ included
Seen enough? Book a 30-minute walkthrough of the modules that matter most for your facility.
WHY SCICORD?
SciCord isn’t a re-packaged enterprise LIMS. It’s built specifically for compounding pharmacies – which is why it deploys in weeks, not quarters, and costs a fraction of what legacy vendors charge.
FDA-audited. Zero system-related findings.
SciCord customers have been through FDA inspections. The system has never been cited. For a compliance purchase in this market, that’s the only proof point that matters.
Your spreadsheets become the starting point
Your existing batch record spreadsheets are the configuration starting point, not something you abandon. Analysts work in a spreadsheet-like interface they already understand – no re-training, no IT project.
Operational in weeks, not quarters
Most facilities go live within 2–4 weeks of contract signature. IQ/OQ/PQ documentation is provided as part of implementation – not commissioned separately as an additional project.
90% lower cost of ownership
Formulated Solutions documented $360,000 per year in savings after implementing SciCord. The investment typically pays for itself in the first year through reduced rework, faster reviews, and avoided inspection costs.
HOW SCICORD COMPARES
Spreadsheets + paper
Enterprise LIMS
SciCord
Implementation
Already in place
6–18 months
2–4 weeks
Part 11 compliant
No
With extra config
By design
Audit trail
Manual / none
Complex to configure
Built-in
Validation package
None
Separate project
Included (IQ/OQ/PQ)
Annual cost
Low – but high risk
$$$$ / year
90% less than LIMS
503A/503B specific
No
Generic pharma
Built-in
See the specific savings number for your facility
We were able to incorporate SciCord into our daily operations immediately. They have been easy to work with.”
Christina B.
EM Investigator
Mid-Market (51-1000 emp.)
[I like] customization of data and forms to match specific needs [and] ongoing collaboration in addressing errors or process improvements.”
Angel G.
EM Manager
Mid-Market (51-1000 emp.)
SciCord with an excel like interface has made recording experimental data user-friendly and quick.”
Scientist
Small-Business (50 or fewer emp.)
It’s a great bridge between our inventory and our processes, which are constantly changing. SciCord is able to handle those changes and dynamic processes with ease since the launch.”
Mining Facility Analyst
Small-Business (50 or fewer emp.)
for its value, usability, and documentation. The UI feels modern and intuitive, and new users have been able to pick it up quickly … Support has also been responsive and genuinely helpful whenever we’ve needed it.”
Debora G.
Chief Manufacturing & Development Officer
Small-Business (50 or fewer emp.)
This product is great—it’s very easy to use and straightforward … Everything has been working smoothly.”
Elvia B.
EM Trainer
Mid-Market (51-1000 emp.)
Improved traceability: SciCord Informatics Platform keeps track of all resources used in the laboratory such as users, instruments, samples and reagents. It also provides multiple security levels and a data audit trail traceability and compliance with regulatory requirements like FDA 21 CFR Part 11 and ISO 17025.
Improved sample management: SciCord Informatics Platform allows you to define properties for sample identification such as date of receipt, date of sampling, batch number and barcode identification. SciCord supports work requests (testing or activities to be performed), sample results, and sample inventory.
Improved productivity: SciCord provides an efficient review process to eliminate data review backlogs which plague many laboratories.
Easy access to data: the integrated search functions allow users to find information more quickly. An integrated DataMart supports queries and reports.
Yes. From an intellectual property perspective, the use of an ELN or LIMS has several advantages. It provides a more secure environment than paper because it can limit the access to data based on profiles. It also helps to create a written record of actions and all required traceability including witness. The ELN or LIMS integrates secure mechanisms such as time stamps and digital signatures on sensitive actions that cannot be changed. Consequently, it’s possible to prove the date of experiments. In addition, the electronic format helps avoid readability problems which you would sometimes see with scanned documents or handwriting.
SciCord deploys several instrument interface strategies, depending on the type of instrument and the level of interface required.
Real time data collection from instruments such as balances and pH meters is provided by monitoring an IP address. This means once a scientist identifies an instrument, a real time display of the instrument output is provided and the scientist records the instrument data directly.
Some instruments feature a result database. SciCord can connect to the database, obtaining result sets, and recording pertinent information.
For instruments which only supply a printed report, SciCord supplies a special printer driver to capture the printer output directly into the SciCord database as a pdf file.
For instruments which generate files, the files identified are attached to the document/experiment with appropriate context.
Finally, custom solutions are available to support interface to more exotic instruments.
Is all information indexed and searchable? Can users query and combine data from multiple experiments, not just return a list of experiments?
SciCord provides several levels of data reporting. The first level is at the document or experiment level where the results generated by an analysis or process are summarized and formatted to facilitate understanding of the outcome(s). Summarization of data can also be accomplished at the sample or lot level. Finally, a DataMart is supplied which organizes analysis or process data across experiments/lots. The DataMart is constructed to optimize queries and retrieval using JMP (SAS), Spotfire (Tibco), or Power BI (Microsoft).
An AI-powered ELN uses artificial intelligence to assist with experiment documentation, data interpretation, automated compliance checks, and structured data modeling going well beyond static electronic notebooks to help scientists spend less time on manual tasks and more time on scientific insight.
An AI-native LIMS isn’t just a conventional LIMS with AI bolted on. It’s built with AI as a foundational layer, enabling semantic data relationships, machine learning readiness, intelligent automation, and deeper scientific context across the entire lifecycle of samples, results, and workflows.
An AI-native Informatics Platform unifies experiments, samples, workflows, instruments, results, and decisions into a single semantic data layer. Platforms like SciCord automatically build a Laboratory Knowledge Graph from operational data, enabling advanced analytics, context-aware AI assistants, and machine learning across the lab – not just isolated within standalone modules like ELN or LIMS.
SciCord embeds AI directly into daily workflows from parsing unstructured data into structured tables, suggesting intelligent actions, assisting in compliance review, answering natural-language questions about your lab data. This built-in intelligence accelerates review cycles, detects anomalies early, and supports traceability without compromising compliance.
Yes. Leading AI-native platforms such as SciCord combine embedded AI capabilities with full support for GxP compliance, audit trails, electronic signatures, and FDA 21 CFR Part 11 readiness — making them suitable for regulated R&D, QC, and manufacturing laboratories.
SciCord informatics platform goes beyond basic ELN and LIMS functions with a range of additional lab informatics capabilities that are also enhanced by built-in AI. The platform includes scientific data management (SDMS) for controlled document review, approval, and versioning that leverages AI to help parse and organize content for easier retrieval and compliance tracking. SciCord supports electronic batch records and manufacturing execution workflows where AI can assist in structuring batch data, spotting trends, and flagging potential deviations before they occur. Inventory and equipment tracking tools are part of the solution and use intelligent data linking to help predict shortages or maintenance needs. These modules sit on the same connected data layer, so AI can draw context from samples, workflows, documents, and tests to provide insights across the lab rather than in isolated silos.
Responsible AI in regulated labs doesn’t alter official records directly instead, it proposes outputs (e.g., suggested tables, summaries, or interpretations) that must be reviewed and accepted by a human before being finalized. This ensures adherence to compliance and audit requirements while still realizing AI efficiencies.
All SciCord systems are kept up to date with the latest patches and security protections. External penetration tests are conducted on a regular basis, one for every major release of the software, which is typically once every year.
SciCord maintains a password policy which covers a certain level of complexity, minimum length (8), lockout, etc. A Least Privilege Access policy is in place, which means that a User is able to access only the information and resources that are necessary for their legitimate purpose. Also, there are controls to review and assess the appropriateness of access at least once every 12 months.
Yes. In our SLA we include Continuity Plans, which are tested and validated.
Yes. SciCord has been through compliance inspections and external audits.
SciCord conducts development on-premise, using a virtual machine package that is standardized for all developers. There are policies and guidelines in place, as well as a web-based access model, to manage how the process is performed. Also, SciCord does not outsource any of its code development. The development follows an SDLC process, which includes quality control, testing policies, support policies, etc. The SciCord Solution code is regularly tested against OWASP top 10; e.g. Qualys and TinFoil.
Yes. From an intellectual property perspective, the use of an ELN or LIMS has several advantages. It provides a more secure environment than paper because it can limit the access to data based on profiles. It also helps to create a written record of actions and all required traceability including witness. The ELN or LIMS integrates secure mechanisms such as time stamps and digital signatures on sensitive actions that cannot be changed. Consequently, it’s possible to prove the date of experiments. In addition, the electronic format helps avoid readability problems which you would sometimes see with scanned documents or handwriting.
Yes! SciCord customer environments are hosted in the award-winning Azure cloud to assure data security. Stored data is encrypted in the database to protect against intrusion, and when transmitted between your site and the Cloud servers.
Yes. SciCord will integrate with third party or in-house metrology, LIMS, SAP, and document repositories. Custom integrations are available at cost.
SciCord Informatics Platform is offered using the SaaS (Software as a Service / Cloud) model. This means all infrastructure, maintenance and support are provided by SciCord. The product is offered with either a monthly or annual subscription.
The scale of an organization can have an impact on informatics requirements. Smaller organizations can rely on interactions between individuals to “find” information and facilitate communication within and across projects. As organization size increases, the communication barriers naturally increase, often dramatically. For larger organizations, searching for information and efficient collation is paramount. Large organizations require a DataMart solution to facilitate finding and organizing information across multiple projects and over a potentially long time frame.
The single greatest challenge for most organizations is committing the resources required to push the implementation over the finish line. Any implementation requires contributions from the group of individuals most skilled in the target processes. These folks are typically also the most overworked people in the organization.
A second challenge is the boundaries between groups within an organization. Think analytical and QA or manufacture and QC. One group is typically driving the process and the other group may not be focused resulting in delays.
SciCord is provided as a service. This means technology updates are transparent to the customer. To use SciCord, customers only need PCs running Windows – no investment in expensive hardware or support staff.
SciCord offers full support for implementation and customization. Each client is assigned a Project Manager, who coordinates the deliverables between Lab Personnel and SciCord QA, Template Developer and Testers. All staff speak English, and some speak Italian fluently. SciCord provides a project management tool (RedMine) to coordinate the implementation activities.
Upgrade of a GxP compliant solution is often difficult and time consuming. SciCord provides a complete verification documentation set which often allows a customer to approve an upgrade without on premises testing. Once approved, SciCord upgrades the customer environment to the new release overnight. No additional effort is required by the customer.
The application is extended using standard spreadsheet (Excel) functionality. This means anyone with spreadsheet expertise can implement new functionality. Training for simple extensions requires just a few hours. The training required for more complex extensions is dependent on the level of Excel expertise.
SciCord provides a parameter driven API language. Most manipulations require a single line of instruction. The API can be understood in a single 4 hour training session.
SciCord is based out of Cary, North Carolina with a support center in Verona, Italy. Support is provided during 8-5 office hours for time zones throughout Europe, and the east coast and west coast of the USA.
SciCord employees are available for training and implementation activities on-site or remotely.
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.

Josh Guyer,
Senior Pharmaceutical Scientist